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Aanbevolen vacatures

Site Coördinator Pipelines
Tormans Group, Wallonië
Voornaamste taken Suivi et coordination des travaux de Génie Civil et de Piping sur le terrain sous la direction du chef de projet.* Contrôle de la qualité lors de l’exécution des travaux (Plans, cahiers des charges, Méthodes d’exécution, …).* Suivi et Respect de la sécurité au quotidien (Contrôle des instructions, Aspects VCA, Préparation du travail, …).* Respect du planning lors de l’exécution des travaux (délais d’interventions, coordination des acteurs externes et internes, …).* Contrôle du respect du budget (Contrôle des prestations effectuées, suivi de travaux en régie et suivant contrats définis, …).* Tâches administratives lors de l’exécution des travaux (Commandes, réception de matériel, carnets de soudures, réalisation d’as-built.Les projets portent sur l’exécution de travaux d’ entretiens et d’adaptations en canalisations Profiel Vous disposez d’un Bachelor ou d’un Master en Electromécanique ou dans une orientation technique, un diplôme de géomètre est aussiaccepté.* Vous avez une très bonne connaissance du néerlandais (MUST) et du français tant à l’oral qu’à l’écrit.* Une expérience dans le piping est un atout majeur.* Vos qualités sont : sens de l’initiative, sens élevé de l’organisation,aptitude à résoudre des problèmes, communication aisée, précision, esprit critique, flexibilité, ...* Un diplôme VCA** et un certificat de secourisme d’entreprise sont un must, vous êtes disposé à avoir ces diplômes rapidement.* Vous êtes disposé à effectuer des déplacements professionnels entre les sites (déplacements nationaux), si nécessaire à loger pour des durées relativement courtes.
Director, Pipeline Project Management - Vaccines
1925 GlaxoSmithKline LLC, Wavre
GSK site preferred locations: Upper Providence, PA (Collegeville), Wavre, Belgium, Siena, Italy. Hybrid role: on-site 2-3 days per week strongly preferred. Additional flexible arrangements considered on case-by-case basis. Pipeline Project Management drives decisions and enables teams to choose the best path and deliver medicines to patients faster than ever. In GSK, the Pipeline Project Manager Vaccines (PPM) will act as the ‘COO’ of the asset and will partner with project leads to help teams plot the best course, then accelerate through complexity and uncertainty with no compromise to quality or safety.  Pipeline Project Managers compose a community of drug/vaccine development and commercialization experts applying industry-leading project management practices to plan and deliver pipeline projects with industry-leading performance: Apply a holistic perspective and broad knowledge of drug/vaccine development to help Research and Development teams test ideas and optimize the strategy. Empower teams to challenge convention, manage uncertainty, and accelerate delivery of critical milestones. Continuously assess progress and clear the way for uninterrupted focus on the critical path. Build high-performing teams by cultivating trust and outcomes-focused ways of working. Share learnings and proven practices across PPM so that we learn and grow as an organization. The PPM can also operate at program level, as when (for example) a franchise or disease-area team oversees multiple projects under the umbrella of a single program strategy. The Director brings significant experience and demonstrates success managing R&D pipeline projects within a complex life sciences organization. The Director can independently manage multiple projects and is considered a strategic thought partner to the project team leader in defining and delivering project goals by applying expertise in varying PM methodologies. The Director PPM leads the creation, optimization, and execution of ambitious plans with accountability for all asset/workstream PPM deliverables. The Director leads the application of established project management approaches and resources and influences the development of new capabilities. The Director may lead Associate Director PPMs and/or flexible service providers, with or without a formal reporting relationship. Key Responsibilities: Oversee projects deliverables and guide strategy and governance preparation for direct reports to ensure outcomes consistent with PPM expectations. Facilitate and/or contribute to asset strategy and evidence strategy, and lead development of the integrated project plan to ensure feasibility and alignment with TA strategy, prioritization, and pipeline performance objectives. Own the single integrated plan that builds team commitment to shared goals with schedules and budgets based on clear dependencies and assumptions. Lead options planning, generate recommendations, alternatives, and tradeoffs to strengthen decision-making and optimize the project strategy. Leads team preparation for governance decisions and owns schedule, risk, and budget inputs. Identify opportunities to accelerate by challenging constraints that impact critical path and near-critical path activities. Orchestrate seamless handoffs with focus on the critical path through proactive project plan monitoring, risk management, and cross-functional management of project issues with timely escalation to leadership as required. Ensure rigor, consistency, and compliance in established systems to drive timely, high-quality data and reporting in and across projects. Build trusting relationships with the team and stakeholders to encourage transparency and collaboration. Use strong facilitation skills to lead regular project team meetings and apply consistent best practice for meeting agendas, actions, minutes, and other meeting documentation. Establish and sustain agreed-upon ways of working for effective team communication, decisions, and conflict resolution. Actively promote GSK’s Code and values. Seek diverse perspectives, cultivate psychological safety, and ensure that all relevant voices are heard to strengthen outcomes and foster broad commitment. Work on any assignment as directed. Why you? Basic Qualifications: Bachelor’s Degree in Life Sciences or Business with 10+ years of project management experience in a matrix team environment in pharmaceutical R&D or related industry. Experience in all aspects of project management based on established PM principles and methods (e.g. PMI/PMBOK), including scenario analysis, risk management, planning and execution, critical path management, lessons learned, communication and reporting. Experience building and maintaining project plans, budget and resource forecasts, and project management documentation (key assumptions, risks, etc.).  Experience using established PM planning tools. (ie: Planisware, MS Project, etc.) Experience facilitating project team meetings. Experience preparing for governance interactions to enable funding, resourcing, and strategic and operational project decisions. Experience leading and facilitating the identification, visualization, and acceleration of the project’s critical path, and the ability to present the critical path activities and dependencies to project stakeholders. Preferred Qualifications: Project Management Expertise Master’s Degree/Advanced Degree with PMP certification Minimum 10 years of project management experience in a matrix team environment in pharmaceutical R&D or related industry. Demonstrated expertise in all aspects of project management, based on established PM principles and methods (e.g. PMI/PMBOK). Extensive experience building and maintaining high-quality project plans, budget and resource forecasts, and project management documentation (key assumptions, risks, etc.).  Expert-level ability to communicate clear, concise view of project status, critical path, and upcoming work to help the team and functions work in concert.  Experience leading and facilitating the identification, visualization, and acceleration of the project’s critical path, including the ability to explain the critical path activities and dependencies to project stakeholders. Extensive expertise in managing project risks, ensuring that the risks across functions are appropriately identified, measured, managed, and communicated. Expert proficiency in established PM planning tools. Extensive experience facilitating and documenting effective project team meetings. Experience leading or contributing to organizational project management capabilities and PM-related improvement initiatives as needed. Drug Development Experience Deep understanding of drug development and organizational knowledge to validate the operational feasibility, challenge project team assumptions, and prompt subject matter experts to consider the impact of portfolio strategy and external landscape (regulatory, commercial, and competitive). Extensive experience guiding teams to develop recommendations and options inclusive of benefit, cost, and risk trade-offs to realize the project strategy. Extensive experience preparing for governance interactions to enable funding, resourcing, and strategic and operational project decisions. Leadership & Interpersonal Skills Knowledge of formal high-performance team concepts and experience leading or partnering with project leaders to establish and sustain a high-performance team environment. Demonstrated ability to build trust and strengthen collaborative relationships with matrixed team members across teams, sub-teams, and functions. Demonstrated ability to identify, capture, share, and apply learnings and best-practice across projects. Demonstrated experience proactively collaborating with a wide variety of project, functional, and leadership stakeholders. Knowledge of established models for critical thinking, innovation, negotiation, and influencing skills, and experience leading teams in the use of those models to achieve positive outcomes. #LI-GSK Please visit to learn more about the comprehensive benefits program GSK offers US employees. Why Us? GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
Director, Senior Director & Executive Director, Safety Physician SERM (Safety Evaluation & Risk Management)
1054 GlaxoSmithKline Services Unlimited, Wavre
Description , as this will not be available post closure of the advert.  When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. *LI-GSK Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: Medical Doctor (physician) (or equivalent e.g. veterinarian/dentist with appropriate PV experience), with additional relevant medical or scientific post-graduate qualifications. Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.  Experience working in large matrix organizations Advanced experience in the Pharmaceutical or Biotech industry working in Medical Affairs, Pharmacovigilance, Drug Safety or a related field. Preferred Qualifications & Skills: If you have the following characteristics, it would be a plus: An understanding of both clinical trial safety and post marketing. Experience of working with oncology patients. GMC registered or local equivalent Why Us? GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Pharmacovigilance Scientists - Associate Director/ Director/ Senior Director
1925 GlaxoSmithKline LLC, Wavre
Pharmacovigilance Scientists - Associate Director/ Director/ Senior Director Positions in GSK Safety Evaluation and Risk Management (SERM) - Specialty Safety Business. Exciting opportunities to make a significant impact on patients’ lives Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting.  Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks. Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally. If appointed as a manager (i.e., Team/Group Leader) is responsible for leadership of a team of individual contributors. Line Management (including functional matrix reports) leadership competencies include resource and team management, coaching, influencing others, collaborative working, decision making, change management, partnership, and relations management. If you are passionate about working with colleagues with world-class scientific expertise focused on delivering medicines and devices of significant value for patients and public health, we have Pharmacovigilance Scientist opportunities in the Specialty SERM Group: Bringing together more than 300 products, including best in class, first in class, growth and pipeline assets, our pharmacovigilance Specialty/General Medicines portfolio represents an incredible opportunity to impact the lives of 700+ million patients in the next 10 years. Many of the GSK heritage brands we manage are the leader in their therapy area or even the number one pharmaceutical brand on the market. We provide pharmacovigilance and comprehensive benefit-risk management for advanced Respiratory medicines and devices, Allergy/immunoinflammatory and Dermatology, Neurosciences, Anti-infectives including anti-microbials, antivirals (ViiV Healthcare) and antimalarials, Urology, CV/Metabolic, Hepatology and many more! Product support ranges from R&D into Post-approval, Established & Generics. We have exciting opportunities for you to join our team and be motivated by colleagues, engaged and energized by the science and inspired by the patients whose needs we strive to meet. Scientific/Medical Knowledge PV Expertise Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix. Leads the safety component of global regulatory submissions.  Expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis and interpretation. Demonstrated track record of quality decision making and creative problem resolution, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.  Demonstrates highly developed multi-tasking skills, ability to prioritise tasks and consistently delivers on deadlines, with high performance standards for quality.  Explores positions and alternatives to reach mutually beneficial agreements and solutions. Cross-functional Matrix team leadership Leads safety governance by development of safety strategy and its execution for products in clinical development and post marketing settings. Anticipates, detects and addresses product safety issues (e.g., product incidents) and ensures that risk-reduction strategies are implemented appropriately. Facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.  Represents GS on cross-functional Clinical Matrix Teams and/or Project Teams. Leads cross-functional ad hoc teams to address urgent and important product safety issues.  Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality and efficiency.  Authors/participates in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently. Accountable for the escalation of issues and communication on safety matters (e.g., GSB, CHSLC, GLC, QPPV). Builds strong working relationships and displays excellent leadership skills on safety issues whilst working in a matrix team, with a demonstrated ability to lead a team in a matrix setting. Ability to coach and mentor others. Communications (verbal, written) and Influencing (internal PV Governance and External LTs) Leads presentations on recommendations or safety issues to senior staff members at the GSK Senior Governance Committees. Has the skillset to interact with confidence, credibility, and influence at all levels of the GSK organisation. In addition, is expected to represent GSK and contribute to safety related discussions at meetings with regulatory authorities, outside consultants and other companies such as licensing partners. Leads cross-functional process improvement team within GSK. Thinks tactically/strategically and takes account of the internal and external environment when considering safety issues and changes to SERM processes or business improvements. Contributes to development of long-term strategy for clinical programs. Regularly contributes innovative ideas to address new issues or improve approaches to existing operations.  Leads inspection readiness and prepared as needed to support audits/inspections. Excellent communication (verbal, written) and influencing (internally and externally) skills. Relevant Degree qualification. Higher level of education/qualification in life science discipline or relevant experience. Advanced experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, Drug Safety, Medical Affairs, or a related field. Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities. Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes. Cross-functional Matrix team leadership in large organizations. Appropriate behavioural competencies. Strong: Leadership Capability, Strategic Thinking, Business Acumen, Project Management, Communication Skills. Ability to work across global sites. Why Us? GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Pharmacovigilance Scientists - Associate Director/ Director/ Senior Director
1925 GlaxoSmithKline LLC, Rixensart
Pharmacovigilance Scientists - Associate Director/ Director/ Senior Director Positions in GSK Safety Evaluation and Risk Management (SERM) - Specialty Safety Business. Exciting opportunities to make a significant impact on patients’ lives Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting.  Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks. Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally. If appointed as a manager (i.e., Team/Group Leader) is responsible for leadership of a team of individual contributors. Line Management (including functional matrix reports) leadership competencies include resource and team management, coaching, influencing others, collaborative working, decision making, change management, partnership, and relations management. If you are passionate about working with colleagues with world-class scientific expertise focused on delivering medicines and devices of significant value for patients and public health, we have Pharmacovigilance Scientist opportunities in the Specialty SERM Group: Bringing together more than 300 products, including best in class, first in class, growth and pipeline assets, our pharmacovigilance Specialty/General Medicines portfolio represents an incredible opportunity to impact the lives of 700+ million patients in the next 10 years. Many of the GSK heritage brands we manage are the leader in their therapy area or even the number one pharmaceutical brand on the market. We provide pharmacovigilance and comprehensive benefit-risk management for advanced Respiratory medicines and devices, Allergy/immunoinflammatory and Dermatology, Neurosciences, Anti-infectives including anti-microbials, antivirals (ViiV Healthcare) and antimalarials, Urology, CV/Metabolic, Hepatology and many more! Product support ranges from R&D into Post-approval, Established & Generics. We have exciting opportunities for you to join our team and be motivated by colleagues, engaged and energized by the science and inspired by the patients whose needs we strive to meet. Scientific/Medical Knowledge PV Expertise Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix. Leads the safety component of global regulatory submissions.  Expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis and interpretation. Demonstrated track record of quality decision making and creative problem resolution, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.  Demonstrates highly developed multi-tasking skills, ability to prioritise tasks and consistently delivers on deadlines, with high performance standards for quality.  Explores positions and alternatives to reach mutually beneficial agreements and solutions. Cross-functional Matrix team leadership Leads safety governance by development of safety strategy and its execution for products in clinical development and post marketing settings. Anticipates, detects and addresses product safety issues (e.g., product incidents) and ensures that risk-reduction strategies are implemented appropriately. Facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.  Represents GS on cross-functional Clinical Matrix Teams and/or Project Teams. Leads cross-functional ad hoc teams to address urgent and important product safety issues.  Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality and efficiency.  Authors/participates in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently. Accountable for the escalation of issues and communication on safety matters (e.g., GSB, CHSLC, GLC, QPPV). Builds strong working relationships and displays excellent leadership skills on safety issues whilst working in a matrix team, with a demonstrated ability to lead a team in a matrix setting. Ability to coach and mentor others. Communications (verbal, written) and Influencing (internal PV Governance and External LTs) Leads presentations on recommendations or safety issues to senior staff members at the GSK Senior Governance Committees. Has the skillset to interact with confidence, credibility, and influence at all levels of the GSK organisation. In addition, is expected to represent GSK and contribute to safety related discussions at meetings with regulatory authorities, outside consultants and other companies such as licensing partners. Leads cross-functional process improvement team within GSK. Thinks tactically/strategically and takes account of the internal and external environment when considering safety issues and changes to SERM processes or business improvements. Contributes to development of long-term strategy for clinical programs. Regularly contributes innovative ideas to address new issues or improve approaches to existing operations.  Leads inspection readiness and prepared as needed to support audits/inspections. Excellent communication (verbal, written) and influencing (internally and externally) skills. Relevant Degree qualification. Higher level of education/qualification in life science discipline or relevant experience. Advanced experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, Drug Safety, Medical Affairs, or a related field. Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities. Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes. Cross-functional Matrix team leadership in large organizations. Appropriate behavioural competencies. Strong: Leadership Capability, Strategic Thinking, Business Acumen, Project Management, Communication Skills. Ability to work across global sites. Why Us? GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.