Het overzicht van de statistiek van de lonen bij het beroep "Managing Director in Belgium"

Location: Poland - home-based    Schedule: Full-time, permanent         CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.         As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.       Join our team and help us deliver clinical trials that will improve patients' lives.         Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Masters degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in Poland:Internet compensation of up to PLN 80 per monthInsurances: Group Accident (employer funded), medical care, and social fund (as per Polish regulations)PPK Pension participation (as per Polish regulations)Meal VouchersFlexible working hoursOccasional work from homeHolidays: Between 20 and 26 days per year, depending on seniorityRefund on corrective glasses for computer work (as per Polish regulations)Annual Christmas partySeniority Bonus (5y-1.000PLN, 10y-2.000PLN,15y-3.000PLN, 20y-4.000PLN)  The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.      If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact [email protected] for more information.         Who will you be working for?         About CROMSOURCE          CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                          Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Strategy Lead, CMC, CRO, Outsourcing, Regulatory, Regulatory OperationsLocation: PolandShare: LinkedIn Facebook Twitter Email

Location: Spain - home-based    Schedule: Full-time, permanent         CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.         As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.       Join our team and help us deliver clinical trials that will improve patients' lives.         Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Master's degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in Spain:Competitive SalaryHealth insuranceHome office allowanceMeal vouchers23 days of holiday per year + 2 convenio days and bank holidays  The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.      If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact mailto [email protected] for more information.     Who will you be working for?         About CROMSOURCE          CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                          Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Strategy Lead, CRO, Outsourcing, Regulatory, Regulatory OperationsLocation: SpainShare: LinkedIn Facebook Twitter Email

Location: Italy - home-based    Schedule: Full-time, permanent         CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.         As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.       Join our team and help us deliver clinical trials that will improve patients' lives.         Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Masters degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in Italy:Meal vouchersMobile phone if requested by the Line ManagerDedicated Line ManagerMonthly meetings with the line managerFull performance and development process with end-of-year reviews  The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.      If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact [email protected] for more information.         Who will you be working for?         About CROMSOURCE          CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                          Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Strategy Lead, CMC, CRO, Outsourcing, RegulatoryLocation: ItalyShare: LinkedIn Facebook Twitter Email

Location: Netherlands - home-based    Schedule: Full-time, permanent     CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.       As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Masters degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in the Netherlands:Competitive SalaryGroup health insuranceGreat pension scheme24 vacation days (but up to 30 days, depending on negotiation)Internet reimbursementCompany Car with fuel card depending on the function.Full performance and development process with end-of-year reviews The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.    If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact [email protected] for more information.         Who will you be working for?         About CROMSOURCE         CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                        Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Regulatory Affairs Director, Strategy Lead, Clinical Research Organisation, CRO, Regulatory, Regulatory OperationsLocation: NetherlandsShare: LinkedIn Facebook Twitter Email

Location: Germany - home-based    Schedule: Full-time, permanent         CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.         As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.       Join our team and help us deliver clinical trials that will improve patients' lives.         Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Masters degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in Germany:30 Euro net Internet cost reimbursement per monthAdditional Accident Insurance, fully covered by the company25 vacation daysPossibility of salary conversion for additional pension insuranceDedicated Line Manager The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.      If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact [email protected] for more information.         Who will you be working for?         About CROMSOURCE          CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                          Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Regulatory Affairs Director, Strategy Lead, Clinical Research Organisation, CRO, Regulatory, Regulatory OperationsLocation: GermanyShare: LinkedIn Facebook Twitter Email

Location: Belgium - home-based    Schedule: Full-time, permanent     CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.       As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Masters degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in Belgium:Competitive SalaryGroup and hospitalisation insuranceElectronic meal vouchersInternet reimbursementCompany Car with fuel card depending on the function.Dedicated Line Manager The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.    If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact [email protected] for more information.         Who will you be working for?         About CROMSOURCE         CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                        Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Regulatory Affairs Director, Strategy Lead, Clinical Research Organisation, CRO, Regulatory, Regulatory OperationsLocation: BelgiumShare: LinkedIn Facebook Twitter Email

Location: Italy - Hybrid (2 days in office) Schedule: Full-time, Permanent     CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Medical Writing Director.       The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments. This role will provide written and verbal feedback to the internal team and clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities: Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.Plans and organizes workload for assigned projects and tasks identifies project needs, tracks timelines, and implements clients' requests.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Presents on Medical Writing processes at full-service bid defense meetings.Develops and delivers training to the global team in various aspects of medical writing.Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.Oversight of a portfolio of clients.Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.Provides scientific and technical guidance to the client and Medical Writers.Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Education and Experience:At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory. Experience in DSUR will be considered an added advantage.An understanding of the drug development process.Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.Experience in interacting with cross-functional study team members. Specific Role Requirements and Skills:Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.Read, write, and speak fluent English, excellent verbal, and written communication skills.Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.Culturally aware and able to work comfortably within a global team. The Application Process  Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information.     Who will you be working for?     About CROMSOURCE       CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                    Our Company Ethos  Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.     About TalentSource Life Sciences   TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.     CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.     Keywords: Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writing.Skills: Medical Writer, CER, clinical trials, Medical Writing, Outsourcing, PharmacologyLocation: ItalyShare: LinkedIn Facebook Twitter Email

Location: Belgium - Hybrid (2 days in office)Schedule: Full-time, permanent     CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations.     The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities:Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process  Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information.     Who will you be working for?     About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                    Our Company Ethos  Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.     About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.     CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.     Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, Submissions.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: BelgiumShare: LinkedIn Facebook Twitter Email

Location: Italy - Hybrid (2 days in office)Schedule: Full-time, permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations. The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.  CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, SubmissionsSkills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: ItalyShare: LinkedIn Facebook Twitter Email

Location: Spain - Hybrid (2 days in office)Schedule: Full-time, permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations. The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                   Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.  CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.  Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, Submissions.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: SpainShare: LinkedIn Facebook Twitter Email

Location: Poland - Hybrid (2 days in office)Schedule: Full-time, permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations. The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, Submissions.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: PolandShare: LinkedIn Facebook Twitter Email

Location: Belgium - Hybrid (2 days in office) Schedule: Full-time, Permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Medical Writing Director.   The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments. This role will provide written and verbal feedback to the internal team and clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.Plans and organizes workload for assigned projects and tasks: identifies project needs, tracks timelines, and implements clients' requests.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Presents on Medical Writing processes at full-service bid defense meetings.Develops and delivers training to the global team in various aspects of medical writing.Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.Oversight of a portfolio of clients.Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.Provides scientific and technical guidance to the client and Medical Writers.Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Education and Experience:At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory. Experience in DSUR will be considered an added advantage.An understanding of the drug development process.Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.Experience in interacting with cross-functional study team members. Specific Role Requirements and Skills:Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.Read, write, and speak fluent English, excellent verbal, and written communication skills.Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.Culturally aware and able to work comfortably within a global team. The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writing.Skills: Medical Writer, CER, clinical trials, CRO, Medical Writing, Outsourcing, PharmacologyLocation: BelgiumShare: LinkedIn Facebook Twitter Email

Location: Netherlands - Hybrid (2 days in office) Schedule: Full-time, Permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Medical Writing Director.   The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments. This role will provide written and verbal feedback to the internal team and clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.Plans and organizes workload for assigned projects and tasks: identifies project needs, tracks timelines, and implements clients' requests.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Presents on Medical Writing processes at full-service bid defense meetings.Develops and delivers training to the global team in various aspects of medical writing.Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.Oversight of a portfolio of clients.Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.Provides scientific and technical guidance to the client and Medical Writers.Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Education and Experience:At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory. Experience in DSUR will be considered an added advantage.An understanding of the drug development process.Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.Experience in interacting with cross-functional study team members. Specific Role Requirements and Skills:Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.Read, write, and speak fluent English, excellent verbal, and written communication skills.Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.Culturally aware and able to work comfortably within a global team. The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writingSkills: Medical Writer, CER, clinical trials, CRO, Medical Writing, Outsourcing, PharmacologyLocation: NetherlandsShare: LinkedIn Facebook Twitter Email

Location: Germany - Hybrid (2 days in office) Schedule: Full-time, Permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Medical Writing Director.   The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments. This role will provide written and verbal feedback to the internal team and clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.Plans and organizes workload for assigned projects and tasks: identifies project needs, tracks timelines, and implements clients' requests.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Presents on Medical Writing processes at full-service bid defense meetings.Develops and delivers training to the global team in various aspects of medical writing.Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.Oversight of a portfolio of clients.Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.Provides scientific and technical guidance to the client and Medical Writers.Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Education and Experience:At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory. Experience in DSUR will be considered an added advantage.An understanding of the drug development process.Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.Experience in interacting with cross-functional study team members. Specific Role Requirements and Skills:Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.Read, write, and speak fluent English, excellent verbal, and written communication skills.Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.Culturally aware and able to work comfortably within a global team. The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                   Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writing.Skills: Medical Writer, CER, clinical trials, CRO, Outsourcing, PharmacologyLocation: GermanyShare: LinkedIn Facebook Twitter Email

Location: United Kingdom - Hybrid (2 days in office) Schedule: Full-time, Permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Medical Writing Director.   The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments. This role will provide written and verbal feedback to the internal team and clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.Plans and organizes workload for assigned projects and tasks: identifies project needs, tracks timelines, and implements clients' requests.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Presents on Medical Writing processes at full-service bid defense meetings.Develops and delivers training to the global team in various aspects of medical writing.Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.Oversight of a portfolio of clients.Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.Provides scientific and technical guidance to the client and Medical Writers.Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Education and Experience:At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory. Experience in DSUR will be considered an added advantage.An understanding of the drug development process.Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.Experience in interacting with cross-functional study team members. Specific Role Requirements and Skills:Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team membersRead, write, and speak fluent English, excellent verbal, and written communication skills.Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.Culturally aware and able to work comfortably within a global team. The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information.  Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writing.Skills: Medical Writer, CER, CRO, Medical Writing, Outsourcing, PharmacologyLocation: United KingdomShare: LinkedIn Facebook Twitter Email

Location: Poland - Hybrid (2 days in office) Schedule: Full-time, Permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Medical Writing Director.   The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments. This role will provide written and verbal feedback to the internal team and clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.Plans and organizes workload for assigned projects and tasks: identifies project needs, tracks timelines, and implements clients' requests.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Presents on Medical Writing processes at full-service bid defense meetings.Develops and delivers training to the global team in various aspects of medical writing.Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.Oversight of a portfolio of clients.Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.Provides scientific and technical guidance to the client and Medical Writers.Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Education and Experience:At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory. Experience in DSUR will be considered an added advantage.An understanding of the drug development process.Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.Experience in interacting with cross-functional study team members. Specific Role Requirements and Skills:Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.Read, write, and speak fluent English, excellent verbal, and written communication skills.Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.Culturally aware and able to work comfortably within a global team. The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writingSkills: Medical Writer, CER, CRO, Medical Writing, Outsourcing, PharmacologyLocation: PolandShare: LinkedIn Facebook Twitter Email

Location: Spain - Hybrid (2 days in office) Schedule: Full-time, Permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Medical Writing Director.   The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments. This role will provide written and verbal feedback to the internal team and clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.Plans and organizes workload for assigned projects and tasks: identifies project needs, tracks timelines, and implements clients' requests.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Presents on Medical Writing processes at full-service bid defense meetings.Develops and delivers training to the global team in various aspects of medical writing.Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.Oversight of a portfolio of clients.Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.Provides scientific and technical guidance to the client and Medical Writers.Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Education and Experience:At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory. Experience in DSUR will be considered an added advantage.An understanding of the drug development process.Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.Experience in interacting with cross-functional study team members. Specific Role Requirements and Skills:Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team membersRead, write, and speak fluent English, excellent verbal, and written communication skills.Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.Culturally aware and able to work comfortably within a global team. The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.   About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writing.Skills: Medical Writer, CER, clinical trials, CRO, Medical Writing, Outsourcing, PharmacologyLocation: SpainShare: LinkedIn Facebook Twitter Email

Role Purpose:The M&A Director supports the company by managing the acquisition project and corresponding valuation, due diligence and integration of targets. They will be the owner of the M&A process and will be the driver of the business case in order to allow Exco and Board to take well founded decisions. The M&A Director will collaborate closely with the senior management to support the decision and monitor the progress.Responsibilities:Valuation and price proposal through the identification and preparation of a business plan in coordination with the respective business functions (VP or EVP) and the relevant synergiesPresent conclusions and recommendations on projects/acquisitions to senior management and Executive CommitteeSelect, appoint and coordinate external M&A advisors with the required expertise areasDeal negotiation based on Executive Committee mandate for medium size M&A within the bolt on acquisitions Driving of the complete due diligence process by ensuring all key value creators are assessed in support of the business planIdentifying key risks and opportunities of the project and ensuring they are reflected in the price adjustmentsPropose deal structuring supported by the relevant functions (e.g. tax, financing) Ensuring the deal documents support the agreed dealPost-acquisition: drive the first stage of the integration of newly acquired companies before transferring to the respective P&L ownerWork collaboratively with the senior management in identifying merger and acquisition targets within the business’s marketLead of the project team and management of the agreed timelines between Sibelco and the targetEnsure proper integration within the organization

Job Description Your mission Responsible for achieving target conversion for reactive and reservation sales. Responsible for overall proactive sales deployment both locally and internationally inclusive of prospecting targets. Responsible for the performance and optimization of all channels inclusive of 3rd party channels such as OTAs and Group intermediary platforms. Partners with Revenue Management to assist in the development of the hotel sales and distribution strategy and ensures that these strategies are communicated Accountable of the hotel website content in terms of key unique selling points and accuracy of copy and imagery Support the development of the hotel positioning within the market and be the voice of the consumer to help shape up the long-term positioning strategy of the hotel. Working side by side with hotel Revenue Manager to define sales strategies We offer A competitive salary package including a salary based on your current competencies Mealvouchers, Eco-chèques, Sport & Culture chèque Hospitalisation and Group insurance Employee benefit card offering discounted rates at both Accor worldwide and in HIVELY HOSPITALITY network Learning programs through our academies Opportunity to develop your talent and grow within your property and across the world Managing a team of 5 co-workers, in Sales, Events & Reservations 237 premium Pullman rooms, 3 F&B outlets & 1,200 sqm of modulable event space Qualifications Your profile  Strong Leadership skills Commitments to achieve budgets The ability to develop and implement successful sales strategies Extensive knowledge of group, catering, contract and transient business Extensive knowledge of Luxury segments and customers (if applicable) Ability to interpret market data and apply to sales strategy Knowledge of operations and associated challenges for all brands Effective decision-making skills Effective coaching and development skills Fluent in French, English and Dutch

About BCW Brussels:At BCW Brussels, you will find a collegiate and collaborative environment focused on opportunity and a growth mindset. Our teams are diverse and talented and deliver innovative solutions to our celebrated client roster. We offer depth and breadth of communications capabilities and industry expertise, matched by innovative tools. Our counsel and campaigns are increasingly digital and social, and we make the most of BCW’s global network to create global impact and move people. For more information on BCW Brussels: We believe that creating truly inclusive and innovative solutions is critical to our success, so Inclusion, Diversity, Equity and Accountability ( are embedded into everything we do for our people, agency, clients, and the communities we serve. We strongly encourage applications from talent across all dimensions of race/ethnicity and the LGBTQ+, differently abled. The Role:We are looking for an experienced consultant (Director level) to join our Healthcare & Food team in Brussels. This is an exciting opportunity to develop and implement impactful EU and multi-market health policy programs that will contribute to shaping the future of the European healthcare innovation ecosystem. In this role, you will be able to work with a wide range of stakeholders (for example, EU and national policymakers, industry, patient communities, medical societies, media influencers) with a view to drive tangible and meaningful policy impact and improve healthcare systems outcomes.  What you'll do as you move with us:Lead and grow a portfolio of healthcare and consumer health projects, while nurturing client relationships and delivering strategic and well-thought-out integrated communications programs. Work with account teams and clients to identify opportunities to deliver greater impact and results. Take a proactive role in new business development, and in agency operations and forums, contributing to the strength of our broader team both internally and externally.Mentor and train junior colleagues and support them to deliver best-in-class consulting services.Share knowledge and best practice and position BCW externally on the healthcare & food sector and policy developments.Experience that contributes to your success:Extensive experience with a focus on healthcare, consumer health or medical technology within an agency or similar environments.Proven experience of leading projects is essential as well as involvement in building strong client relationships.Experience in developing and deploying public affairs programs, disease awareness campaigns and advocacy relations is essential.Experience of managing account financials, internal forecasting, and reporting.Growth Mindset: we are looking for individuals who want to challenge both themselves and the status quo, who will bring their true selves and their passion to the team, and the work we do.Experience in managing complex fast-paced situations successfully. Ambitious and entrepreneurial with a robust, determined, and hands-on approach.Self-motivated, blended with impressive interpersonal skills.Excellent written and verbal communications skills along with strong attention to detailDesire to work in a diverse and inclusive organization as an active participant in culture initiatives, training opportunities and employee resource groups.More about BCW:BCW is the global communications agency that moves people on behalf of clients. BCW partners with clients in the B2B, consumer, corporate, crisis management, healthcare, public affairs, purpose and technology sectors to set strategic direction for all communications and create powerful and unexpected ideas that earn attention. Through an “Earned-Plus” offer – earned media plus paid media, creative technology, data, AI andan expanding suite of innovative capabilities – BCW moves people with power and precision to move its clients forward. BCW is a part of WPP (NYSE: WPP), a creative transformation company. For more information, visit . Our Promise  BCW are committed to growing and sustaining an agency that is both representative and inclusive of the communities we live and work within. At BCW, we believe that a diverse and inclusive workforce enables our agency to thrive and deliver brilliant work. We actively welcome applications from under-represented individuals and groups and celebrate differences, be it ethnicity, religion, age, gender, gender identity or expression, sexual orientation, marital status, or disability. We will only assess you on your abilities and fit for the role, please do get in touch if you would like to discuss any reasonable adjustments you need to ensure a level playing field during the recruitment process.