Takeda Pharmaceuticals U.S.A., Inc. jobs in Boston, MA

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Our mission is to create an agile and predictive scientific and technical organization supporting manufacturing and supply of Takeda portfolio products and collaborating with R&D/Pharmaceutical Sciences on enabling late phase development and industrializing commercial manufacturing of new innovative medicines for our patients around the world through robust CMC processes. Global Manufacturing Science is a part of Global Manufacturing and Supply and is based in Boston. How you will contribute: * Support the commercial manufacturing of active pharmaceutical ingredients/drug substances through the review of relevant documents and compile certain parameters in excel sheet * Perform statistical tools including digital tools designed for the purpose * Contribute to manufacturing investigation through collecting the relevant information from the documents provided * Assess the quality and regulatory impact in line with the guidelines Internship Development Opportunities: * How to learn and apply regulatory principles of commercial manufacturing in pharmaceutical industry * Approaches to solving real-world problems in commercial manufacturing using Digital and statistical tools * Methodologies in using real-world evidence (RWE) to help deliver medicines to patients globally * Exposure to professional environment and development of commercial settings Job Requirements: * This position will be Hybrid and require 2-3 days in the Cambridge office per week. * Applicants must be enrolled in a U.S. accredited university for the semester before and immediately following the internship. * Applicants must be pursuing a Bachelor's degree and have completed at least their freshman/sophomore year or be a graduate level student pursuing either a PharmD or Master's degree * For Bachelor's and Master's degree students, a major in healthcare, pharmacy or life science field is preferred. Internship Eligibility * Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship * Must be currently enrolled in a degree program graduating December 2026 or later * The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st) * The intern must be able to commit to one of these time frames * Able to work full time 40 hours a week during internship dates * Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program Program Highlights: * Hands-on experience with real projects and responsibilities * Dedicated mentorship program pairing interns with experienced professionals * Networking opportunities with industry professionals and fellow interns * Internship events focused on professional and skills development * Exposure to multiple business areas or departments within a Pharmaceutical Organization Applications will be accepted between November 7th- January 4th. Takeda Compensation and Benefits Summary We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Hourly Wage Range: $21.00 - $46.00 The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. internship benefits vary by location and may include: * Paid sick time * Civic Duty paid time off * Participation at company volunteer events * Participation at company sponsored special events * Access to on-site fitness center (where available) * Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Paid Intern (Fixed Term) (Trainee) Time Type Full time Job Exempt No It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions * Independently conduct audits * Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits * Facilitate Sponsor health authority inspections of global clinical facilities and study sites * Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs * Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. * May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements * Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. * 5+ years of experience in GCP auditing. * Substantial experience in inspection management. * Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. * Demonstrated ability to operate and influence decision-making processes * Effective communication skills * Successful track record of supervising employees and managing cross-cultural differences * Technical and administrative capabilities to independently carry out routine, complex and for-cause audits * Knowledge of data integrity controls and systems quality for clinical area * Strong analytical skills and report writing skills * Experience with GxP systems including computer system validation and associated regulations, recommended. * Ability to Travel (approximately 20%) * Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

Job Title: Transformation Leader - External Manufacturing - Biologics About the Job Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster. EM&S is leading the SANOFI CMO network and is committed to engage and manage external partners delivering exceptional manufacturing solutions. As we embark on a journey of growth and expansion, we are seeking a dynamic and experienced professional to lead our Business Transformation efforts in EM&S Spe Care. The Transformation Leader at the EM&S GBU level plays a key role in supporting transformation initiatives within the EM&S GBU. Acting as the primary link between the central transformation office and local EM&S GBU teams, the Transformation Leader ensures that projects are successfully adopted and embedded into daily operations. This role is focused on driving engagement, building change readiness, and ensuring that the transformation objectives deliver sustainable impact within the GBU. This positioning makes the Transformation Leader a "local transformation enabler": ensuring alignment with global vision, while guaranteeing practical adoption and ownership in the GBU. This is a hybrid role - 3 days a week onsite - required. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities: Support Transformation Delivery * Partner with the Global Transformation Leader to implement enterprise-wide programs within the GBU. * Localize change strategies to fit the GBU context, culture, and priorities. * Act as a key point of contact for all change-related activities in the GBU. Drive Adoption & Engagement * Ensure employees and managers understand the why, what, and how of transformation initiatives. * Develop and execute communication and training plans to maximize adoption. * Monitor adoption and embed new behaviors, processes, and tools into the GBU. Stakeholder & Leadership Support * Build strong relationships with GBU leaders to support them as change sponsors. * Provide coaching and guidance to managers and teams to reinforce change behaviors. * Act as a trusted advisor to GBU leadership on change readiness and risks. Change Measurement & Reporting * Track change adoption KPIs and report progress to the Transformation Leader and GBU leadership. * Identify resistance, barriers, and adoption gaps, and proactively recommend solutions. * Capture lessons learned to continuously improve change implementation in the GBU. About You * Bachelor's degree in Business, Human Resources, Organizational Development, or related field. * 5+ years of experience in change management or organizational transformation. * Strong knowledge of CMO/CDMO manufacturing - Required. * Strong knowledge of change management frameworks * Demonstrated ability to work in complex, matrixed organizations. * Excellent communication, facilitation, and interpersonal skills. * Proven track record in supporting digital, operational, or organizational transformation programs. * Certification in Change Management or Project Management is a plus. Key Competencies of a Transformation Leader As a CMO Business Operations & Transformation Lead, here are the essential competencies that a transformation leader must master: Vision & Strategy * Strategic thinking: Ability to see the "big picture" and anticipate trends * Organizational alignment: Connect transformation to business objectives Change Management * Change management: Master methodologies * Resistance management: Identify and address barriers to change * Change communication: Adapt messages to different audiences Operational Competencies * Project/Program Management * Business acumen with ability to translate transformation into operational impact. * Problem-solving and analytical thinking. * Process optimization: Identify and implement improvements * Digital literacy: Understand emerging technologies (AI, automation, cloud) * Innovation: Promote experimentation and learning Relational Competencies /Leadership & Influence * Cross-functional work: Orchestrate multi-functional teams * Inspirational leadership: Mobilize and engage teams * Influence without authority: Convince stakeholders at all levels and relationship building at GBU level. * Emotional intelligence: Understand and manage emotions during change change * Negotiation: Find compromises and create consensus Soft Skills * Communication: Strong communication and facilitation skills (Clarity, active listening, storytelling) * Empathy: Understand the human impact of change * Resilience and adaptability in dynamic environments. Why Choose Us? * Bring the miracles of science to life alongside a supportive, future-focused team. * Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. * Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. * Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Onsite #vhd Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $147,000.00 - $212,333.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Daiichi Sankyo, Inc. (DSI) is currently seeking a Medical Science Liaison (MSL) to join the Field Medical Affairs Team. The MSL develops ongoing professional relationships with national and regional healthcare opinion leaders and other healthcare professionals to provide medical and scientific support for Daiichi Sankyo, Inc. (DSI) initiatives in selected therapeutic areas. The MSL develops skills and competencies to educate healthcare professionals, DSI internal stakeholders (e.g., Medical, Marketing, and Sales), and decision makers in healthcare systems regarding therapeutic areas and related products developed and commercialized by DSI. This is a US Medical Affairs, Field based role. This territory currently covers the following states: ME, NH, VT, NY, CT, RI, MA Responsibilities: Builds and maintains professional relationships with healthcare professionals (HCPs) by developing the skills and with guidance, implementing the following: Presenting disease state and Daiichi Sankyo product specific data to HCPs Responding to unsolicited requests for medical information Identifying and appropriately facilitating engagement of qualified 1) investigators and study committee members for DSI clinical research programs, 2) investigator-initiated research study proposals, 3) speakers for DSI Brand Speaker programs, 4) advisors for DSI scientific, clinical and marketing advisory boards Gathering customer insights regarding DSI and competitor products to help inform medical and commercial decision-making Enhanced professional expertise through attendance of select scientific meetings and professional conferences for the purpose of continuing education and scientific exchange with key opinion leaders Develops positive working relationships with local and regional internal stakeholders to enhance DSI HCP relationships Develops the ability to apply the appropriate methods to implement the FMA department strategy within his/her geography in alignment with Medical and Brand strategies Completes administrative duties, including monthly expense reporting and field activity reporting Represents the Medical Science Liaison function by participating in DSI meetings, functions, events Additional duties and responsibilities are based on position level/title, and may include but are not limited to: Provides innovation in enhancing and developing professional relationships with national and regional healthcare opinion leaders and HCPs to provide medical and scientific support for DSI initiatives. Ability to anticipate trends and capitalize on opportunities Lead special projects/initiatives. Assist in the development of team members Represent FMA leadership at DSI meetings, functions and events Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university): PharmD, MD, PhD, NP or PA in a health sciences-related field or an equivalent combination of education and experience preferred Experience Qualifications: MSL/Sr. MSL 1 or More Years' experience, including medical & scientific affairs, clinical practice, research, academic or US-managed markets preferred Previous experience in Oncology, clinical research and medical education preferred Principal MSL/Associate Director MSL 5 or More Years' experience including medical & scientific affairs, clinical practice, research, academic or US managed markets preferred Previous experience in Oncology, clinical research and medical education preferred Additional Qualifications: Must have a valid driver's license with a driving record that meets company requirements Ability to travel up to 60% Compensation and seniority level/title based on experience and qualifications. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $150,800.00 - $226,200.00 Download Our Benefits Summary PDF

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products. Uses sound statistical methodology to conduct studies relating to the life cycle of the product. In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards. Develops and/or applies statistical theories, methods, and software. Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used. Provide specifications and directions to the clinicians/statistical programmers. Supports the regulatory review and approval of the experimental therapies. May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data. Job Description Summary We are seeking a visionary leader to shape and drive Clinical Data Science strategy across our global clinical development portfolio. This role ensures the rigorous application of statistical principles and advanced data science methodologies to optimize clinical trial efficiency and accelerate innovation. The Executive Director will spearhead the integration of AI/ML solutions for applications in disease diagnosis, modeling, imaging, genomics, proteomics, and precision medicine. Acting as the primary data science representative to global regulatory authorities, this individual will defend strategies and influence industry standards. Strategic Leadership: Define and execute Clinical Data Science strategies for clinical studies and development plans across the portfolio. Serve as the primary spokesperson for Data Science at Health Authority meetings, leading preparation of responses and influencing regulatory perspectives. Innovation & Execution Drive adoption of cutting-edge AI/ML methodologies for disease modeling, biomarker analysis, and precision medicine. Oversee multiple large-scale, critical data science initiatives, ensuring timely, high-quality deliverables aligned with industry best practices. Risk Management & Problem Solving Evaluate analytical options, proactively identify risks, and develop novel solutions to complex challenges. Thought Leadership & External Engagement Represent the organization at technical seminars and conferences; build networks with industry experts to advance best practices. Team Leadership & Development Manage and mentor a diverse team of data scientists and people managers across geographies. Foster career growth through open dialogue, performance management, and strategic development planning. Operational Excellence Ensure GxP compliance in data science programming for clinical trials. Manage budgets, vendor relationships, and third-party deliverables to maintain quality and efficiency. Executive Communication Deliver clear, compelling communication of complex data science concepts to internal and external stakeholders with executive presence. Qualifications Ph.D. in Biostatistics, Bioinformatics, or related computational sciences. Deep expertise in statistical methods and their application in clinical trials. Minimum 10 years of industry experience in clinical development, including Data Science and Biostatistics. Recognized thought leader in at least one data science discipline (e.g., AI/ML modeling, precision medicine). Proven experience presenting at external forums and influencing regulatory authorities. Strong people leadership experience in a Data Science setting. Prior research experience in neurology, particularly Alzheimer's disease biomarkers (plasma, CSF, imaging), strongly preferred. Eisai Salary Transparency Language: The annual base salary range for the Executive Director, Clinical Data Science is from :$283,200-$371,700Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ********************************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

Job Title: Global Regulatory Affairs CMC lead About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. As GRA CMC Lead within our GRA CMC & GRA Device Organization, you'll drive global regulatory strategies for pharmaceutical and vaccine products, collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and directly influence the success of drug approvals through strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role offers the opportunity to drive regulatory strategy for pharmaceutical products and vaccines across their lifecycle. Working at the intersection of science and compliance, you'll develop CMC strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities including FDA and EMA. You'll collaborate across R&D, Manufacturing, and Quality teams while preparing high-quality regulatory submissions, managing compliance, and anticipating regulatory trends-all contributing directly to bringing innovative therapies to patients worldwide About Sanofi We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. The Global Regulatory Affairs (GRA) CMC & Device Organization within Sanofi R&D serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on Chemistry, Manufacturing, and Controls (CMC) and medical device regulatory requirements across the product lifecycle. Our department bridges the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways. The team develops and implements global regulatory strategies for pharmaceutical products, biologics, vaccines, and combination products, working closely with cross-functional partners to navigate complex regulatory landscapes. With a commitment to Sanofi's "Take the Lead" values, particularly in "Leading Together" and "Being Bold," our mission is to secure timely approvals while maintaining the highest standards of quality and compliance, ultimately supporting Sanofi's goal of bringing innovative healthcare solutions to patients worldwide. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Develop and implement global regulatory CMC strategies Create strategies for development and marketed products Focus on chemical entities, biological entities, and/or vaccine products Execute and adapt strategies as needed Serve as the primary point of contact for regulatory authorities Act as direct liaison with agencies like US FDA and EMA Develop positive relationships with regulators Support strategic negotiations with worldwide Regulatory Health Authorities Manage CMC documentation and submissions Write, prepare, review, and approve regulatory CMC dossiers Ensure dossiers meet quality standards Comply with regulatory requirements Maintain documentation accuracy and completeness Lead cross-functional collaboration Work closely with R&D Functions Collaborate with Manufacturing & Supply Functions Coordinate with GRA Regulatory Operations Ensure effective implementation of regulatory strategies Facilitate resolution of CMC issues Identify and manage regulatory risks Assess regulatory CMC opportunities and risks Develop risk mitigation strategies Communicate implications to project teams Articulate risk/benefit components to stakeholders Contribute to regulatory science and policy activities Monitor local and international Health Authority regulations and guidelines Participate in the review process for new regulations Anticipate potential regulatory paradigm shifts Track and communicate current Health Authority thinking and trends About You Experience: 4+ years of CMC regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions. Regulatory Expertise: Experience preparing regulatory documentation and familiarity with standard submission processes Technical Knowledge: Understanding of pharmaceutical development, manufacturing processes, and regulatory requirements in major markets. Collaboration Skills: Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Manufacturing, and Quality teams. Education: Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field). Communication: Strong written and verbal communication skills, with fluency in English. Adaptability: Capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site), with openness to learning and growth. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Play a crucial role in bringing innovative therapies to millions worldwide, working at the forefront of drug discovery and development with a patient-centric approach. Leverage advanced AI, data, and digital platforms to push the boundaries of pharmaceutical science and regulatory strategy. Engage with diverse teams spanning scientific, clinical, and digital fields, fostering breakthroughs through cross-functional collaboration. Benefit from structured career paths offering both scientific and leadership advancement opportunities, including bold moves and short-term projects to expand your expertise. Join a workplace that prioritizes diversity, equity, and inclusion, with programs that celebrate every voice and perspective. Enjoy a supportive R&D environment that values work-life balance, offering flexible working options (60% on-site) and comprehensive well-being programs. Influence global regulatory strategies, interact with key health authorities, and stay at the forefront of evolving industry trends and regulations. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA #LI-Onsite #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $122,250.00 - $176,583.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The purpose of this role is to develop and implement account specific strategies to meet objectives for assigned regional payer accounts including Commercial, Medicare and Medicaid (State Medicaid agencies, managed Medicaid, and select client representatives of Medicaid Pharmacy Benefit Administrators). This role serves as the primary point of contact between Eisai and Regional Payer Accounts representing Eisai's product portfolio across all payer channels. The Regional Account Executive will be responsible for creating and maintaining access to Eisai's product portfolio in all assigned regional payer accounts and achieving defined objectives and goals within assigned regional payer accounts while building a strong corporate presence with key decision-makers, thought-leaders, and stakeholders. The Regional Account Executive will be responsible for managing access and policy for Eisai's products and appropriately communicating status with stakeholders including Market Access Leadership, Field Sales, other Account Executives, Marketing, HEOR and other headquarter personnel. This role is responsible for facilitating appropriate formulary positions and executing Eisai strategies in assigned regional payer account(s) which includes expertise with negotiating contracts, executing brand strategies and tactics, and educating on access at the local level. The Regional Account Executive will also be expected to assist at headquarters or in the field in projects that will optimize brand performance in the various payer channels. These projects may be brand specific, payer-specific or channel-specific. Essential Functions * Present the economic value proposition and clinical benefits of Eisai product portfolio to assigned regional payer account contacts to establish brand access. Negotiate and manage account contracts in support of Eisai product portfolio (as applicable). * Coordinate with all Commercial and Medicare National Account Directors and National Account Executives to work with downstream regional payer accounts of the national payers. Review and analyze applicable data to make informed decisions on regional payer accounts in terms of contract execution and performance. Appropriately communicate coverage for Eisai products to internal Eisai cross-functional stakeholders. Work with various key internal stakeholders to align national account business plans with brand plans and effectively implement those plans at local level. Keep senior management updated on all key issues at account(s) in a timely manner. Develops business plans for customers based on the marketplace within which they operate. * Work closely with Medicaid Director and other cross-functional teams to review and analyze applicable data to make informed decisions on individual states and multi-state pooling initiatives in terms of appropriate rebates and contract execution. * Develop strong corporate presence with nationally targeted State Medicaid agencies. * Closely monitor state Medicaid pharmacy and therapeutic committee (P&TC) and Drug Utilization Board (DURB) meetings for appropriate planning and implementation to maximize patient access across the Eisai portfolio. * Ability to build effective business plans that align with Eisai Product access goals based on the regional payer accounts they manage. Work with various stakeholders on projects that optimize the business. * Compliantly educate and inform Eisai field sales of access status for both medical and pharmacy benefit products. Work with various key internal stakeholders to align national and regional payer account business plans with brand plans and effectively implement those plans at local level. Keep senior management updated on all key issues at account(s) in a timely manner. * Drive company-leased vehicle to meetings with health care providers and other appropriate stakeholders and partners. When necessary, travel overnight including within territory and to conferences, training, and sales meetings. * Consistently demonstrate uncompromised integrity while working cross-functionally and collaboratively with internal and external stakeholders. Strong understanding of legal and regulatory parameters related to market access. Comply with all Eisai promotional and administrative policies and applicable law. Requirements * The candidate should possess strong large customer relationships, business acumen, account knowledge, and contract strategy/negotiation experience across all payer channels. * Experience working with commercial, Medicare, and Medicaid accounts and a proven record of success in both pharmacy and medical benefit environments are preferred. * Four-year college degree or higher * Strong business and analytical background * Minimum (10) years of pharmaceutical industry experience preferred * Minimum (2) years in pharmaceutical payer account management roles preferred * Excellent market, account, and customer knowledge. Existing relationships in regional accounts in assigned geography preferred * Strong negotiating/influencing skills * Demonstrated cross-functional team leadership skills * Excellent business writing and presentation skills * Proven record of success in managing managed care accounts in both pharmacy and medical benefit environments As a condition of employment and an essential function of this field-based position, applicants must be able to engage in person with HCPs and other third parties at their offices, institutions and other appropriate locations on a regular basis. In order to gain in-person access, applicants selected for the position may be required to complete third parties' credentialing and/or entry requirements, which often include an attestation to and/or providing proof of having received certain vaccinations. To the extent you are unable to meet certain requirements for qualifying medical (including pregnancy-related) or religious reasons, applicants must request a reasonable accommodation by contacting the Human Resources Department.Skills:Account Planning & Management, Communication & Cross-functional Influence, Critical Thinking & Business Agility, Customer Engagement, Industry & Regulatory (Market Access), Mentoring/ People Development, Project Management Eisai Salary Transparency Language: The base salary range for the Regional Account Executive (Northeast) is from :156,900-205,900 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

Job Title: Principal Process Engineer-Technical Sciences About the Job Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster. The Technical Sciences Group within MSAT Recombinant DS Global Platform function is the owner of Life Cycle Management of commercial manufacturing processes within Sanofi Manufacturing and Supply network. We are the process owners of commercial manufacturing processes, we drive life cycle initiatives and provide commercial manufacturing support, both internally and at CMOs. The function is also responsible for supporting tech transfer activities including process fit-gap assessment, process validation, PAI support, technical troubleshooting and drive continuous improvement initiatives. Our expansive portfolio covers 17 products, 5 modalities, 3 expression systems within 12 internal and external global sites in US and EU. We will be supporting the launch of 20 new products in the next 5 years including monoclonal and multi-specific antibodies, fusion proteins, antibody-drug conjugates. In recent years we have successfully established second-generation manufacturing processes with continuous process platform. We are pursuing future innovations such as digital labs, factory of future and advanced analytics-based process understanding and control. At Sanofi, we have charted a clear path forward to not only minimize the environmental impact across our value chain but also adapt our business to the environmental challenges that we face, promoting Environmental Sustainability by Design through our eco-design approach. This role will drive and execute the strategic direction of Environmental Sustainability by Design initiatives with the organization, fostering a culture of environmental sustainability and innovation in pharmaceutical development” About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs. Drives LCM activities of end-to-end recombinant DS manufacturing processes at CMOs, by partnering with the CMO technical teams and with Sanofi External Manufacturing groups. Provides technical support and routine process monitoring for commercial products Provides person-in-plant technical oversight of manufacturing operations at CMOs and communication to the relevant technical product team. Performs the reviews of manufacturing processes, critical deviations, and/or development and production data. Provides technical support and data analysis for investigations and critical deviations resolution. Recommends and drives continuous improvement initiatives to enhance quality, productivity, recovery, and overall efficiency through Sanofi digital tools. Demonstrates solid understanding and use of engineering principles and practices to solve a range of complex problems in creative and practical ways. Leads small technical project teams · and provides technical guidance to less experienced staff Works with other MSAT groups (internal or CMO) to design necessary experiments; contributes to understanding and interpretation of results; recommends changes or additional experiments Partners with colleagues and CMOs from various functions, such as Engineering, External Manufacturing and External Quality groups. Shepherds the use of digital tools as part of the LCM initiatives. Oversees and reports on overall manufacturing robustness and relevant KPIs. About You Basic Qualifications Bachelor's degree in engineering or science with 10+ years of experience in a tech transfer/tech support for DS manufacturing Master's degree in engineering or science with 8+ years of experience of experience in a tech transfer/tech support for DS manufacturing PhD in engineering or science with 4+ years of experience of experience in a tech transfer/tech support for DS manufacturing Leadership Qualifications Act for Change: embrace change and innovation and initiate new and improved ways of working. Cooperate transversally: collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business results. Lead and Develop People: Build, manage, motivate, and empower teams and workgroups. Take responsibility for developing one's self and others in anticipation of future business needs. Preferred Qualifications Experience in biotechnology or the pharmaceutical industry Experience in purification, cell culture, or analytical methods Experience with root cause analysis and/or risk assessment Knowledge of DeltaV automation Experience working with statistical analysis software Experience providing solutions for difficult technical issues Experience communicating with senior management Strong technical writing and communication skills Experience with high level data analysis Experience with project leadership Experience communicating with cross functional teams Proficient in Microsoft Word, Excel, PowerPoint Special Working Conditions Up to 35% Travel requirement Ability to gown and gain entry to manufacturing areas Support manufacturing operations on an "on call" 24/7 basis Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Onsite #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $147,000.00 - $212,333.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** **Summary:** The Regulatory Data Steward plays a key role in ensuring the quality, integrity, and compliance of regulatory data within the Company's Regulatory Information Management (RIM) ecosystem. This role combines hands-on data analysis and remediation with governance execution, supporting both operational data quality oversight and strategic regulatory compliance needs. The successful candidate will leverage strong data analysis skills, expertise in regulatory data standards, and knowledge of regulatory processes to safeguard master and transactional data. This position provides the opportunity to work across multiple functions and systems, integrating internal and external data assets into RIM platforms, while ensuring alignment with international regulations and the Company's data governance framework. **Key Responsibilities** **1. Operational Data Stewardship** + Monitor, profile, and analyze regulatory data to ensure compliance with defined standards and design specifications (source-to-target validation). + Perform data quality analysis, error detection, documentation, and correction across diverse platforms (SQL, Excel, Informatica, Veeva Vault, third-party applications). + Investigate, troubleshoot, and document data issues raised by internal and external stakeholders. + Support root-cause analysis of data issues and recommend process and system improvements. + Ensure sensitive data is always protected through approved controls and practices. **2. Governance & Compliance** + Implement data governance policies, standards, and SOPs in partnership with Regulatory Data Owners. + Define and maintain data quality controls, metrics, and dashboards within data catalogs and reporting tools. + Ensure processes, methodologies, and metrics are consistently applied to maintain and improve data quality. + Identify and escalate regulatory and legal risks related to data issues, ensuring timely resolution. + Maintain awareness of evolving international regulatory requirements (e.g., IDMP, SPOR, XEVMPD, eCTD, ePI, PQ/CMC, CTIS, ESMP) and assess their impact on RIM data. **3. Collaboration & Escalation** + Act as liaison between Data Owners, Business Process Owners, IT, and external vendors to ensure alignment on remediation and quality improvements. + Participate in cross-business unit forums to resolve data definition, production, and usage issues. + Communicate data quality concerns, escalations, and risks to stakeholders and governance forums in a clear and actionable manner. + Support knowledge sharing and mentoring across the data stewardship community. **4. Vendor & Process Oversight** + Establish, monitor, and report on Service Level Agreements (SLAs) with external vendors performing data stewardship and quality assurance activities. + Ensure external partners deliver consistent, compliant, and high-quality data services aligned with regulatory expectations. **5. Continuous Improvement** + Define processes and frequencies for metadata reconciliation and discrepancy resolution. + Recommend and implement new controls, process enhancements, and automation opportunities to improve data quality. + Support integration of new data assets from M&A, system migrations, or external regulatory sources into RIM.. **Required Qualifications** + 5+ years of experience in the healthcare/pharmaceutical industry. + 5+ years of experience in data management or data governance roles, ideally in a regulatory context. + Bachelor's degree in **Life Sciences, Pharmacy, Data Science, Information Management, or a related field** required. + Master's degree in **Regulatory Affairs, Data Management, or related discipline** preferred. + Strong expertise with the **Veeva RIM data model** and regulatory metadata management. + In-depth understanding of regulatory data standards (IDMP, SPOR, XEVMPD, eCTD, etc.). + Strong analytical and problem-solving skills, including root-cause analysis and remediation. + Hands-on experience with SQL, Excel, and reporting/visualization tools (Power BI, Tableau, or equivalent). + Experience working in GxP environments and familiarity with data privacy regulations. + Ability to work independently with minimal oversight, while influencing diverse stakeholders. + Excellent communication skills, with the ability to translate technical data concepts into business terms. + Experience with regulatory domains such as Labeling, CMC, and broader Regulatory Affairs processes. + Exposure to public and hybrid cloud environments. **Preferred Qualifications** + Experience supporting **large-scale data remediation, migration, or M&A integration projects** . + Experience working with outsourced data stewardship vendors or data service providers. + Knowledge of emerging regulatory frameworks (ePI, ESMP, PQ/CMC). + Familiarity with data quality and governance tools (e.g., Informatica, Collibra, or equivalent). + Change management or process improvement certification (e.g., Lean, Six Sigma, PROSCI). + Proven ability to influence without authority and drive adoption of governance processes **Takeda Compensation and Benefits Summary** We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. **For Location:** Massachusetts - Virtual **U.S. Base Salary Range:** $137,000.00 - $215,270.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** Massachusetts - Virtual **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time **Job Exempt** Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. \#LI-Remote

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Takeda's QCP & PMX is an integral part of the broader Quantitative Pharmacology & Translational Sciences organization within the R&D Data and Quantitative Sciences unit. The mission of QCP and PMX is to globally advance therapeutics by finding the right dose for the right patients with a purpose of maximizing benefit over risk. The model-based meta-analysis (MBMA) is crucial to enhance decision-making in the clinical development of multiple internal assets within Takeda's Oncology therapeutic area. In this role, the QCP & PMX intern will establish a MBMA framework for predicting long-term outcomes (OS/PFS) from the short-term endpoints (ORR, CR, PR etc.) to support early go/no-go decisions and improve future clinical trial designs. How You Will Contribute: Duties will include the following, under the manager's supervision * Literature review: Latest publications & MBMA methodology. * Building a comprehensive database for conducting hands-on analyses. * Model building (link short-term endpoints to PFS/OS) and validation. * Conducting head-to-head clinical trial simulations. * Benchmarking Takeda's internal assets against SoC/external competitors in early development and inform clinical development plan within the oncology space. Internship Development Opportunities: The QCP & PMX intern will learn: * How to apply quantitative skills for addressing clinical drug development questions. * How to conduct cutting-edge hands-on analyses. * Enhance critical thinking, hone communication skills and build supportive professional network. Job Requirements: * This position will be hybrid in the Cambridge office. * The candidate must be pursuing a PhD in Pharmaceutical Sciences, Clinical Pharmacology, Pharmacometrics, Biostatistics, or another relevant field (Candidates with applied projects in Clin Pharm/PMx during their senior Ph.D. years with prior internship experience are preferred). * Demonstrate an understanding of basic concepts in PK/PD and biostatistics. * Be acquainted with standard techniques of model building, validation, and simulations. * Experience in using R/Rstudio software is a plus. * Be motivated to conduct hands-on analyses in the context of clinical drug development with the ultimate goal of bringing back useful insights into the drug-development teams who do not have this kind of background. Internship Eligibility * Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship * Must be currently enrolled in a degree program graduating December 2026 or later * The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st) * The intern must be able to commit to one of these time frames * Able to work full time 40 hours a week during internship dates * Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program Program Highlights: * Hands-on experience with real projects and responsibilities * Dedicated mentorship program pairing interns with experienced professionals * Networking opportunities with industry professionals and fellow interns * Internship events focused on professional and skills development * Exposure to multiple business areas or departments within a Pharmaceutical Organization Applications will be accepted between October 31st- December 14th Takeda Compensation and Benefits Summary We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Hourly Wage Range: $21.00 - $46.00 The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. internship benefits vary by location and may include: * Paid sick time * Civic Duty paid time off * Participation at company volunteer events * Participation at company sponsored special events * Access to on-site fitness center (where available) * Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Paid Intern (Fixed Term) (Trainee) Time Type Full time Job Exempt No It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

The PCP/Endo Business Specialist is responsible for developing and implementing a plan for maximizing net sales of BIPI and co-promoted diabetes products that aligns with direction from BIPI commercial leadership and with BIPI guidelines, policies, and directives. The PCP/Endo Business Specialist will conduct their business with key targeted healthcare providers and community hospitals, and may have additional responsibilities in teaching hospitals, federal and military hospitals, managed health care facilities, group purchasing organizations, integrated delivery networks, etc. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Compensation Data This position offers a base salary typically between ($95K) and ($153,100k). The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements. For an overview of our benefits please click here. Duties & Responsibilities Utilizes product knowledge and demonstrated selling skills in order to influence targeted health care professionals to support the use of BIPI promoted diabetes products. Executes brand strategies to ensure that company sales and marketing messages are delivered appropriately to customers. Establishes and maintains effective communication/cooperation/coordination with co-promotion partners and BIPI employees. Completes pre-call plans to meet key stakeholder needs. Builds discussion around customer needs and opportunities. Fosters customer network development and communication. Has accurate and timely follow-up discussions with customers. Fosters ongoing trust with customer as relationship develops. Uses appropriate BIPI Sales Training techniques to facilitate the customer decision making process. Coordinates the engagement of healthcare providers through a range of personal and non-personal channels, according to customer preferences. Identifies top plans for customers. Engages customers in comprehensive discussions on the payer environment, co-pays, and formulary access. Works with Managed Care Area Managers to generate and sustain support for products on MCO formularies. Develops and influences an extended team to pull-through MCO decisions. Delivers on "continuation of care" model, including discharge protocol, treatment algorithms, disease management, etc. Analyzes qualitative and quantitative territory information to optimize territory business plan and customer calls. Monitors local market conditions for changes that impact business. Develops plans to optimize allocation of key resources, including samples, co-pay cards, funds for speaker programs, and funds for in-office meals. Adjusts implementation plans on a regular basis (speaker mgmt., advocate development, etc.). Leverages opportunities that meet both territory and brand tactics. Utilizes supporting analysis tools to plan activity, report and monitor resource utilization, and maintain account and customer records. Completes all administrative responsibilities as directed by management. Successfully completes all Sales Training requirements. Identifies thought leaders, innovators and advocates to support BIPI products. Works with trained speakers for diabetes topics and products. Provides feedback and follow-up to speakers and attendees. Initiates contacts and network-building among advocates and customer groups. Develops plans to develop speakers and thought leaders. Manages programs and budgets to stay within standards. Works effectively with all customer-facing roles (i.e. Account teams, Medical teams, etc.) in a given geography to meet customer needs and deliver net sales objectives. Demonstrates strong collaboration and communication as customers evolve and ownership of accounts transition from traditional to account based. Performs all Company business in accordance with all regulations (e.g., EEO, FDA, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIPI's excellent reputation within the medical and pharmaceutical community. PCP/Endo Business Specialist Requirements Bachelor's degree from an accredited institution is preferred. A minimum of two (2) years successful sales and/or marketing experience in pharmaceutical/healthcare industry, pharmacy, B2B, customer engagement services or equivalent Experience in diabetes therapeutic area preferred. History of successful performance Meets expectations for the key competencies required for this role Proficiency in Excel, Word, Outlook, and database applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate; exceptions to be granted by senior sales leadership. Valid Driver's License and an acceptable driving record Authorization and ability to drive a Company leased vehicle or authorized rental vehicle. Physical Demands / Surroundings Daily Travel within territory throughout the work day with multiple stops and visits to office buildings, hospitals and clinics. Going up and down stairs, bending, walking and lifting above head to shelf pharmaceutical material or goods. Periodic overnight travel for training and meetings. Intermittent repetitive lifting up to 40 lbs. Visual Demands Pass state motor vehicle vision requirement to operate motor vehicle. Must be able to work both with external and internal customers. Comfortable in new environments and adverse conditions. Temperaments/Mental Requirements Must be able to work with diverse groups of people in similar roles, interact with medical practitioners, business partners, manage stress and conflict associated with gaining access to physicians in a highly competitive environment. Level of Proficiency Must have the ability to learn and retain complex material, pass tests demonstrating product and disease-related knowledge and deliver content to physicians verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements. Attendance / Schedule At least 40 hours per week, requires morning and evening flexibility as necessary to meet physician's schedules and coordinate evening speaker programs - Must be able to function in a self-directed work environment. Proficient in remote engagements with key customers via video conferencing platforms. Able to deliver clear and compliant sales presentations remotely using video, phone and digital media applications. Understands how to build customer relationships that facilitate live and virtual engagement opportunities. These physical and mental requirements represent a sampling of the physical / mental requirements considered essential to the position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed. It is an essential function of/minimum qualification for this position that the employee/applicant be eligible and authorized under all U.S. Export Laws (defined below): a) to be employed by the Company; and b) to receive any technology from the Company that may be required to perform the duties of this position or to which an applicant/employee may, by virtue of holding such position, be provided access by the Company or any third parties during the course of employment. “Export Laws” means the Export Administration Regulations (“EAR”) of the U.S. Commerce Department's Bureau of Industry and Security, presently at 15 CFR §§ 730-799, and the economic sanctions regulations of the U.S. Treasury Department's Office of Foreign Assets Control (OFAC), presently at 31CFR Chapter V, as they may be amended from time to time. Executive PCP/Endo Business Specialist Experience in diabetes therapeutic area preferred History of successful performance Meets expectations for the key competencies required for this role Proficiency in Excel, Word, Outlook, and database applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate; exceptions to be granted by senior sales leadership. Valid Driver's License and an acceptable driving record Authorization and ability to drive a Company leased vehicle or authorized rental vehicle. Physical Demands / Surroundings Daily Travel within territory throughout the work day with multiple stops and visits to office buildings, hospitals and clinics. Going up and down stairs, bending, walking and lifting above head to shelf pharmaceutical material or goods. Periodic overnight travel for training and meetings. Intermittent repetitive lifting up to 40 lbs. Visual Demands Pass state motor vehicle vision requirement to operate motor vehicle. Must be able to work both with external and internal customers. Comfortable in new environments and adverse conditions. Temperaments/Mental Requirements Must be able to work with diverse groups of people in similar roles, interact with medical practitioners, business partners, manage stress and conflict associated with gaining access to physicians in a highly competitive environment. Level of Proficiency Must have the ability to learn and retain complex material, pass tests demonstrating product and disease-related knowledge and deliver content to physicians verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements. Attendance / Schedule At least 40 hours per week, requires morning and evening flexibility as necessary to meet physician's schedules and coordinate evening speaker programs - Must be able to function in a self-directed work environment. Proficient in remote engagements with key customers via video conferencing platforms. Able to deliver clear and compliant sales presentations remotely using video, phone and digital media applications. Understands how to build customer relationships that facilitate live and virtual engagement opportunities. These physical and mental requirements represent a sampling of the physical / mental requirements considered essential to the position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed. It is an essential function of/minimum qualification for this position that the employee/applicant be eligible and authorized under all U.S. Export Laws (defined below): a) to be employed by the Company; and b) to receive any technology from the Company that may be required to perform the duties of this position or to which an applicant/employee may, by virtue of holding such position, be provided access by the Company or any third parties during the course of employment. “Export Laws” means the Export Administration Regulations (“EAR”) of the U.S. Commerce Department's Bureau of Industry and Security, presently at 15 CFR §§ 730-799, and the economic sanctions regulations of the U.S. Treasury Department's Office of Foreign Assets Control (OFAC), presently at 31CFR Chapter V, as they may be amended from time to time

Job Title: Digital Consumer Experience Design About the Job Join the team transforming how healthcare is delivered for chronic and specialty conditions worldwide. In General Medicines, you'll help drive meaningful outcomes in diabetes, transplant, and immunology - with the scale and urgency patients deserve. About Sanofi EDGE: Sanofi EDGE - Building a Healthier Future, Together At EDGE, we're revolutionizing how individuals manage their health and well-being. We believe that lasting health behavior change is best achieved through a supportive ecosystem that includes not only clinical guidance but also the encouragement and practical assistance of a user's care circle. Our platform empowers individuals to set meaningful health goals, track their progress, and connect with their support network, all grounded in evidence-based principles and a deep understanding of human motivation. We're a passionate team dedicated to creating a user-centered experience that drives meaningful health outcomes and fosters long-term engagement. The Opportunity: We are seeking a talented and passionate UX/UI Designer to join our growing product and experience team. As a key member of the team, you will play a crucial role in shaping the user experience of our health management platform. You will be responsible for translating user needs, business requirements, and strategic goals into intuitive, engaging, and effective design solutions. You will collaborate closely with product managers, engineers, and researchers to create a seamless and empowering experience for our users and their care circles. Ideally, you will bring experience designing for consumer health applications, understanding the unique challenges and opportunities within this space. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities: * Lead and contribute to the end-to-end design process, including detailed UI specifications and visual design. * Develop a deep understanding of our users, their motivations (in formed by self-determination theory), and their care circle dynamics through user research, usability testing, and data analysis in collaboration with product and user research team members. * Create user flows, wireframes, prototypes, and high-fidelity mockups that effectively communicate design ideas and solutions. * Design intuitive and accessible user interfaces that are consistent with our brand guidelines and design system. * Collaborate closely with product managers to define product features and translate them into user-centered design solutions. * Work effectively with engineering teams to ensure the successful implementation of designs. * Participate in design reviews and provide constructive feedback to other team members. * Stay up-to-date with the latest UX/UI trends, best practices, and technologies, particularly within the digital health landscape. * Contribute to the evolution and maintenance of our design system. * Advocate for the user throughout the product development lifecycle. About You Qualifications: * Bachelor's degree in Design, Human-Computer Interaction (HCI), or a related field, or equivalent professional experience. * Proven experience (ideally 3+ years) as a UX/UI Designer, preferably with experience in consumer-facing digital products. * Strongly preferred: Experience designing for consumer health applications, with an understanding of health data privacy (e.g., HIPAA), accessibility standards (e.g.,WCAG), and user behavior in health management. * A strong portfolio showcasing user-centered design solutions and demonstrating a clear understanding of UX principles and UI best practices. * Proficiency in industry-standard design and prototyping tools (e.g., Figma, Miro, Adobe XD). * Excellent communication, collaboration, and presentation skills. * Ability to work independently and as part of a cross-functional team in a fast-paced environment. * A strong understanding of user-centered design methodologies and the ability to translate research insights into actionable design decisions. * A passion for improving people's lives through thoughtful and effective design. * Familiarity with agile development processes. Bonus Points: * Experience designing for behavior change or social support platforms. * Knowledge of self-determination theory and its application in digital product design. * Experience working with design systems. * Understanding of front-end development principles (HTML, CSS, JavaScript). * Experience using AI to create workflow efficiency To Apply: Please submit your resume and a link to your online portfolio showcasing your relevant work. In your portfolio, please highlight projects that demonstrate your user-centered design process and your ability to solve complex design challenges. If you have experience in consumer health, please specifically call out those projects. Why Choose Us? * Bring the miracles of science to life alongside a supportive, future-focused team. * Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. * Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. * Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Onsite #vhd Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $125,250.00 - $208,750.00 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

At AstraZeneca, we turn ideas into life-changing medicines. Working here means thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. At AstraZeneca, we are taking bold action on climate because we recognize the connection between healthy people and a healthy planet. As part of our flagship Ambition Zero Carbon program, we have committed to a fully electric vehicle (EV) fleet by the end of 2025, which means that all our drivers will be assigned an EV. As a Senior Pharmaceutical Sales Specialist for the Specialty Care Team, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. Accountabilities - Develop and demonstrate strong knowledge of clinical disease states and treatment guidelines. - Effectively communicate product information to healthcare professionals to influence prescribing behavior. - Execute call plans and Brand Strategy by translating data to actionable insights. - Build and maintain working relationships with healthcare professionals. - Drive portfolio demand performance through meaningful customer interactions leveraging multiple channels, such as digital platforms and face-to-face engagements to reach the customers. - Demonstrate openness to new ideas and seek innovative approaches to sales and customer engagement. Essential Skills/Experience - Bachelor's Degree - 2+ yrs of demonstrated Sales or Commercial experience or a combination of: pharmaceutical, healthcare, scientific, clinical, institutional or related industry experience - A valid driver's license and safe driving record Essential Skills and Capabilities - Customer Engagement: Demonstrated commitment to improving patient outcomes through effective engagement with healthcare professionals. - Advanced Sales Techniques: Experience with advanced sales techniques and strategies tailored to specialty care markets. - Clinical Acumen: Strong understanding of clinical trial data and the ability to communicate complex scientific information clearly. - Business Acumen: Ability to conduct detailed market analysis and leverage insights for strategic planning. Desirable Skills/Experience - Therapeutic area experience, specialization in clinical setting, and sales experience At AstraZeneca, we are on a journey to bring life-saving medicines to patients. Our role in contributing to decreasing mortality rates globally is clear. We shape the future by spotting scientifically led commercial opportunities and acting now to operationalize and scale them. Driven by the solutions we bring to the healthcare ecosystem, we make an impact at every step of the patient journey, improving their experience and outcomes. Our inclusive team draws on diverse backgrounds, skills, and experiences to create innovative solutions that make a difference. Join us in making a meaningful impact on patients' lives by applying today! The annual base salary (or hourly rate of compensation) for this position ranges from $107,172 -$160,758. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted 12-Dec-2025 Closing Date Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Objective / Purpose: The Head of Research Quality holds the highest leadership role within the Research Quality organization and serves as a key member of the R&D Quality leadership team. This executive is fully accountable for defining and executing the global strategic vision for Research Quality, overseeing a global team of experienced subject-matter experts dedicated to ensuring integrity, compliance, and ethical excellence in non-clinical research activities, studies, and processes supporting Takeda's R&D pipeline. Through strategic leadership, impactful stakeholder engagement, and championing an enterprise-wide quality culture, the Head of Research Quality drives organizational success and reinforces Takeda's commitment to industry-leading standards. Accountabilities: Establish and implement a comprehensive global strategic vision for Research Quality, ensuring sustained and impactful contributions to the enterprise. Align this vision with the overarching goals of Research and R&D Quality leadership. Design oversight strategies and effectively deploy resources to mitigate compliance risks for Research non-clinical studies conducted externally in non-OECD Mutual Acceptance of Data system countries. Cultivate influential relationships with key stakeholders to maintain an in-depth understanding of R&D and Research strategies. Leverage this insight to proactively anticipate and address impacts on Research Quality, driving business growth and success. Direct the Research Quality function in designing, implementing, and refining processes that ensure Takeda's non-clinical Research activities are conducted with the highest integrity and compliance with Takeda standards and global regulatory requirements. Architect strategies to foster a culture of continuous improvement, leading initiatives across internal stakeholder groups to uphold quality, compliance, and data integrity throughout Research programs and projects. Spearhead digital transformation and the adoption of cutting-edge science and technology to support data-driven processes and decision-making within Research Quality. Mentor and empower direct and indirect reports across Research Quality, promoting personal development and driving high-performance teams. Develop and sustain collaborative relationships with Research leaders to facilitate productive discussions and align strategies and priorities. Provide strategic oversight to enhance capabilities, mechanisms, and processes for proactive quality risk management across the global Research organization's activities and programs. Maintain and expand knowledge of global regulatory requirements and trends, identifying gaps and implementing solutions to position Takeda at the forefront of industry expectations. Implement strategies for the ongoing development and success of Research Quality, including talent development, succession planning, resource allocation, and budget management, aligning initiatives with R&D Quality and Global Quality. Offer strategic input to the R&D Quality Leadership team on key goals, initiatives, resource planning, and budgetary considerations, ensuring alignment with organizational objectives. Drive strategic alignment and successful achievement of shared goals through collaboration with other functions in R&D Quality and Global Quality. Identify areas of risk and improvement, presenting solutions to address these challenges effectively. Undertake additional duties as assigned, contributing to the overall success of the organization. Education & Competencies (Technical and Behavioral): Minimum requirements: Bachelor's Degree in Chemistry, Biology, Engineering or related field 12+ years of increasing responsibility and experience in the biopharma/biotech industry 8+ years of Quality/Compliance experience Prior management experience Preferred requirements: Advanced degree in Chemistry, Biology, Engineering or related field Experience working in biopharmaceutical research Desired skills & competencies In-depth knowledge of global regulations governing biopharmaceutical research, with the ability to effectively translate and articulate strategies to ensure compliance. Proven leadership, collaboration, and influencing skills, coupled with a demonstrated ability to solve problems and drive impactful change. Proficiency in working with diverse individuals across all organizational levels. Exceptional interpersonal, verbal, and written communication skills, enabling successful interaction with internal stakeholders and vendors. Adaptability and flexibility to thrive in dynamic environments, along with the ability to manage and deliver multiple projects on time. Strong attention to detail and organizational expertise, with a capacity to work independently across global settings and navigate organizational complexities. #GMSGQ #ZR1 #LI-LR1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $208,200.00 - $327,140.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

**Job Title:** Planning and Scheduling Specialist **About the Job** Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster. This organization is responsible for providing Facilities, Engineering and Maintenance support for all cGMP process and utility systems at Framingham MA Campus, maintaining these systems in a validated state of control and ensuring uninterrupted business continuity. This organization is also responsible for shared GMP and non GMP systems on the Framingham campus as defined by Service Level Agreements and this role will support key campus stakeholders including but not limited to Research & Development, Science, Global Manufacturing Sciences and Technology. This organization is also responsible for non GMP maintenance of buildings on the Framingham campus in conjunction with North America Sanofi Business services (SBS) and is the main group interfacing with SBS. Takes a lead role in matters related to asset management, PM program and planning and scheduling of preventive and unscheduled maintenance activities. Contributes to continuous improvement projects and initiatives. **About Sanofi:** We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. **Main Responsibilities:** + Maintains the Computerized Maintenance Management System (CMMS) to plan and schedule work orders, preventive maintenance activities, material lists and asset management. + Receives all work orders from requesting departments and end-users. Assess work request and makes decisions regarding response time and level of planning activities based on priority of requested work. + Adapts to changing production needs and prioritizes work among conflicting schedules and expectations. + Develops maintenance work packages by evaluating work orders for required permits, action notices, job steps, spare parts, tools, labor and opportunities for efficiencies. + Ensures estimate for time required to perform work activities are accurate for the purpose of establishing a schedule. + Utilizes reports to optimize schedule and level loading of resources. + Works in a collaborative team environment and interacts with other departments such as Engineering, Facilities, Validation, Quality, Manufacturing, and Metrology. + Team member or lead for special projects as assigned. + Acts as subject matter expert for work order management, asset management and PM program. + Supports audit requests and CMMS training. + Meets with production and area owners to finalize equipment availability and schedule upcoming maintenance activities. + Utilizes maintenance reports/metrics to manage incoming and future work activities. + Acts as Shutdown Coordinator or participates in the coordination and scheduling of building and utility shutdowns. **About You** **Basic Qualifications** + High School Diploma with 3+ years planning or scheduling or related work experience. + Strong organizational, administrative, and analytical skills. + Working knowledge of Computerized Maintenance Management System (CMMS), Computerized Calibration Management System (CCMS) + Experience working within cross-functional teams. + Working knowledge of quality management systems. + Customer service oriented, works well with internal and external customers. **Preferred Qualifications** + Experience working for a maintenance organization in a cGMP Biotech/Pharmaceutical manufacturing environment. + Knowledge of methods, materials, tools and equipment used in the maintenance of a modern pharmaceutical facility. + Knowledge of industrial and manufacturing equipment with the ability to help coordinate building shutdowns. + Ability to identify potential safety hazards, LOTO requirements, and appropriate precautions applicable to work assignments. + Experience in a Enterprise Asset Management System. **Special Working Conditions** + Ability to gown and enter clean rooms. **Why Choose Us?** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. \#GD-SG \#LI-GZ \#LI-Onsite \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. _North America Applicants Only_ The salary range for this position is: $35.56 - $47.41 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* . Global Terms & Conditions and Data Privacy Statement (*************************************************************** Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (***************************** As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************

Job Title: Head of Material Planning About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The Supply Chain organization is responsible for all supply chain activities across the Massachusetts BioCampus. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: PCU Material Planner Team Member responsibilities are: * Makes sure the 3rd party materials are planned with the right coverage targets as defined by Policy or Critical Material Manager (GSP) in case of exceptions / deviations • Reporting of deviations to coverage targets to Critical Material Manager (GSP) * Reviews SAP requisitions or Site Scheduler requests for Purchase Requisitions * Converts Purchase Requisitions sent by Site Scheduler into Purchase Orders, considering factors such as current inventory levels, safety stock policies, material coverage, , and supplier agreements. * Sends Purchase Orders/Schedule lines to suppliers, respecting suppliers' Lead Time, and updates supplier confirmation for each Purchase Order (order acknowledge) in the system so reception dates are available for the site logistic operations in the system if EDI is not established. In case EDI is in place the Material Planner checks the confirmed date and gets in contact with the scheduler or planner if the confirmed delivery date shows a discrepancy of more than +/-10 days * Assesses the availability of materials. * Collaborate with the quality team to secure the release on-time for third party purchasing materials and the reflection of this time in the ERP system to ensure master data correctness * Manages material issues with Site Planner or Scheduler, depending on the horizon of the issue. * Connects with suppliers to monitor the status of the supply plan and to detect exceptions to it as soon as possible to be able to address them. * Coordinates with Critical 3rd Party Material Planner (GSP) if any risk of material shortage cannot be addressed at the site level. * Support warehouse and/or quality teams in complaint management and related deviations * Communicates monthly rolling forecast to up to 36 months, confirming suppliers' capacity in collaboration with Site Scheduler and Supply Planner. * Provides Forecasts, OTIF data, etc. To Critical 3rd Party Material Planner (GSP) for Supplier S&OPs or Global Supply Review * Ensures system is updated (in terms of supplier feedback to requested supply) for Critical 3rd Party Material Planner (GSP) to be able to get the mid to long-term forecast from the system. * Ensures purchased materials are delivered in time for testing release and use. * Monitor issues regarding shipping and returns. * Track supplies' performance metrics. * Initiate conversation with suppliers and Critical 3rd Party Material Planner (GSP) in case of deviation from expected performance. * Communicate the need for qualifying new suppliers to procurement in case of materials shortages from existing suppliers. * Support the quality related topic for 3rd party materials, including creation and monitoring of change control request (CCR) related to supplier changes/ supplier notifications, new products, etc. • Analyzes and proposes updates to Master Data to enhance industrial performance. * Ensures critical (leadtime > frozen horizon) or high value (ABC > 80% of value) material is flagged as KX relevant and MRP is done in KX unless exception conditions met (VMI in SAP, Quota management in SAP, etc.) and creates BuyBODs The PCU meeting roles of the PCU Material Planner Team Member are: * Leads the MRP Meeting * Contributes to the Level 1 Supply Chain +QDCI meeting * Contributes to the Handover to Scheduler meeting * Contributes to the Transparency meeting * Contributes to Capability Review in case of capacity limiting Material Constraint CI loop contribution of PCU Material Planner Team Member includes: * Collaborating with data steward and suppliers to maintain MRP Data in systems (MOQ, Lead Times, Safety Stocks, etc.). * As DCO, analyzing and preparing proposal of Master Data Evolution to support the industrial performance. Takes responsibility for the availability of components to enable production orders. * Tracks suppliers OTIF and performs root cause analysis for planning changes and action plan follow-up. * Manages performance of Suppliers (OTIF) linked with KSOL. Manages Critical Material (materials at risk and critical suppliers) Key Involvement in Decision-Making Process Key Roles (D,A,I) * A/I: Prepares key insights for Supplier S&OPs, key advisor to identify critical * materials in alignment with Critical Material Manager GSP * A/I: Key advisor in CI initiatives related to material planning, * D: Takes care of implementation of CI initiatives * A/I: Strongly involved in setting thresholds for 3rd party Material in system (e.g., high stock values, long lead times, VMI) About You Basic Qualifications * Bachelor's Degree * 10+ years of materials, purchasing or supply chain experience * 5+ years of supervisory experience * 5+ years of experience working with SAP and inventory management systems * Excellent communication skills * Proficient with MS office applications Preferred Qualifications * Bachelor's Degree in a science or technical field * Experience in pharmaceuticals or a related industry * APICS Certification and 10+ years' experience using SAP, and Oracle strongly desired * Strong understanding of planning and purchasing systems in a CGMP manufacturing environment * Project management skills * Expertise in document management systems * Knowledge and understanding of biopharmaceutical CGMP manufacturing preferably in large scale commercial biologics manufacturing required. * Solid understanding of quality, supply chain, finance and planning * Knowledgeable of requirements for post approval changes and of information typically found in the CMC sections of regulatory submissions * Knowledge and experience with discrepancy investigation and lot disposition. Disclaimer The above information was designed to indicate the general nature and level of work performed by employees with this job description. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an "at will" employment relationship. Why Choose Us * Bring the miracles of science to life alongside a supportive, future-focused team. * Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. * Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. * Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Onsite #vhd Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $114,750.00 - $165,750.00 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** Environment, Health and Safety (EHS) is responsible for ensuring MA Bio Ops maintains compliance with applicable EHS regulations, corporate EHS standards, and maintains the site's EHS management system. The team also focuses on reducing EHS risks at the site through the application of controls, as well as provide support to the site functions by partnering with them to assess risk, identify non-compliance, and to provide recommendations to mitigate both. The primary role of the EHS Intern is to support select EHS compliance activities across the Massachusetts Bio Operations Site. This could include supporting EHS functions within manufacturing, warehouses, laboratories and offices. Performing required inspections and investigations, gathering and analyzing data for reports and EHS software management, providing and developing training, assembling metrics and supporting sustainability initiatives will be core responsibilities. A strong focus will be placed on EHS project. **How You Will Contribute:** As a EHS Intern, you will have the opportunity to... + Support EHS programs to ensure compliance with the latest regulations, best practices or corporate standards. + Work with other Takeda departments and continuously improve data integrity, and compile metrics for internal or corporate reporting + Support EHS related incidents investigations to determine causes. Help establish and implement corrective actions and make recommendations for areas needing improvement. + May develop and deliver EHS training to all personnel as required by regulations and by Takeda standards and procedures. + Gather and manage data related to the EHS programs working with other Takeda departments, consultants, and contractors. **Internship Development Opportunities:** + Learn to work as part of a professional technical support team + Learn how to assess risk and propose effective controls to reduce risk **Job Requirements:** + Must be pursuing a Bachelors Degree in an EHS discipline such as environmental sciences or similar + Creates an environment that inspires an inclusive and diverse culture + Ability to prioritize projects and achieve exceptional outcomes + Comfortable working through ambiguity + Ability to promote change and encourage new ways of working + Proactively takes steps to learn and grow + Confidence working with data and emerging technology **Internship Eligibility** + Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship + Must be currently enrolled in a degree program graduating December 2026 or later + The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st) + The intern must be able to commit to one of these time frames + Able to work full time 40 hours a week during internship dates + Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program ** ** **Program Highlights:** + Hands-on experience with real projects and responsibilities + Dedicated mentorship program pairing interns with experienced professionals + Networking opportunities with industry professionals and fellow interns + Internship events focused on professional and skills development + Exposure to multiple business areas or departments within a Pharmaceutical Organization Applications will be accepted between November 7th - January 2nd **Takeda Compensation and Benefits** **Summary** We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. **For Location:** USA - MA - Lexington - BIO OPS **U.S. Hourly Wage Range:** $21.00 - $46.00 The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. internship benefits vary by location and may include: + Paid sick time + Civic Duty paid time off + Participation at company volunteer events + Participation at company sponsored special events + Access to on-site fitness center (where available) + Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking. **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** USA - MA - Lexington - BIO OPS **Worker Type** Employee **Worker Sub-Type** Paid Intern (Fixed Term) (Trainee) **Time Type** Full time **Job Exempt** No It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Our Data and Quantitative Sciences (DQS) is made up of more than 250 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from statistics, programming, outcomes research and epidemiology, quantitative clinical pharmacology, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and re-imagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation. As part of DQS, the Statistics and Quantitative Sciences (SQS) at Takeda is looking to add individuals to our team that are team oriented, collaborative, strong understanding of the statistics function, exceptional leaders and innovators. SQS aspires to bring safe and effective medications to the patients with our quantitative skills. We design efficient trials, contribute to clinical development strategies, perform high quality statistical analyses, and pursue operational excellence. How You Will Contribute: As an Intern, you will have the opportunity to * Conduct literature reviews and contribute to the prediction model development using various statistical methodologies. * Perform data analysis using SAS, R or python. * Support internal activities like team meetings in preparation of key program activities. * Use of AI enabled tools for efficiency in documents process. * Communicate findings and results effectively with cross-functional teams through written reports and oral presentations. Internship Development Opportunities: * Gain hands-on experience in applying statistical methodologies to drug development and clinical trial analyses * Develop an understanding of regulatory and compliance standards, including how regulatory guidelines influence statistical analyses in clinical trials. * Strengthen project and time management by contributing projects with defined timelines, deliverables and cross-functional collaborations. * Learn to apply machine-learning and predictive modeling techniques to support future study design and planning. * Enhance ability to communicate and justify statistical approaches when addressing questions from cross-functionals. Job Requirements: * This position will be Hybrid and require 2-3 days in the Cambridge office per week. * Must be pursuing a PhD in Biostatistics. * Strong understanding of machine learning concepts and their applications. * Experience in applying machine-learning methods to predict treatment outcome. based on baseline characteristics and selected post baseline biomarkers. * Familiarity with statistical techniques of model development and parameter tuning. * Proficiency in SAS and R programming languages for data manipulation and statistical analysis. Python experience is a plus. Internship Eligibility * Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship * Must be currently enrolled in a degree program graduating December 2026 or later * The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st) * The intern must be able to commit to one of these time frames * Able to work full time 40 hours a week during internship dates * Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program Program Highlights: * Hands-on experience with real projects and responsibilities * Dedicated mentorship program pairing interns with experienced professionals * Networking opportunities with industry professionals and fellow interns * Internship events focused on professional and skills development * Exposure to multiple business areas or departments within a Pharmaceutical Organization Applications will be accepted between November 20th-January 2nd Takeda Compensation and Benefits Summary We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Hourly Wage Range: $21.00 - $46.00 The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. internship benefits vary by location and may include: * Paid sick time * Civic Duty paid time off * Participation at company volunteer events * Participation at company sponsored special events * Access to on-site fitness center (where available) * Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Paid Intern (Fixed Term) (Trainee) Time Type Full time Job Exempt No It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** **Primary** **Role:** The Staff Device Engineer will lead technical efforts for combination products and drug delivery device projects with limited oversight. As a hands-on technical lead/contributor and device subject matter expert (SME), this person will provide project and engineering leadership in the concept, feasibility, development, qualification and launch phases of device development. Area of focus will include identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, equipment development oversight. Extensive collaboration with internal and external partners. This role supports as well a team of device engineers responsible for all the technical aspects of life cycle management of commercialized Combination Products, Medical Devices and pre-filled syringe among others. This role works with cross functional team to support lifecycle management of commercial combination product. The Staff Device Engineer has extensive experience in medical devices for drug delivery including combination products, solid understanding of polymeric medical device manufacturing processes via molding and assembly, and solid knowledge of global standards for the combination products. This key technical role is responsible for change controls, manufacturing process validation, device product complaints, regular review of DHF, and post-market surveillance as related to on-market products. This role interacts with external CLO and CMO and vendors, works closely with drug product, quality, regulatory, program leadership, etc. and establish strategic working relationships. **Responsibilities:** + Plans and coordinates work with departmental and cross functional peers (within and outside Pharm Sci) with an understanding of project timelines/deliverables and define risks and recommend contingency plans as required. + Evaluates impact of decisions across CMC functions. + Makes significant independent contributions to complex pipeline or functional area project. May significantly contribute to more than one project within functional area. + Independently designs, executes and reports results. Proactively analyses manufacturing issues and coordinates potential solutions with the CMC team. Assists in the technical aspects of negotiation with vendors. + Coordinates support of specific technical issues related to projects + May proactively address issues during or resulting from manufacturing. + Provide technical leadership and contribution on cross functional teams for devices through clinical development, product registration and commercialization. Own and lead the creation of design control deliverables to comply with medical device and combination device regulations. + Lead project execution activities and oversee the development of statistically sound design verification protocols/reports and design validation. + Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers. + Lead or assist in deviation, complaint and failure investigations. **Education and Experience** **Requirements:** + Bachelor's degree and 8+ years relevant industry experience **or** master's degree and 6+ years relevant industry experience, **or** PhD and 0+ years in the field of combination product or medical device development and commercialization is desired. + Minimum of 6 years leading cross functional teams and projects. Hands on technical support and lab skills for measurement using various instruments required + Experience supporting regulated devices / combination products under Design Control (21 CFR 820), ISO13485, and ISO14791 requirements. + Knowledge of global industry standards (ex: ISO, AAMI, ANSI, etc.). + Hands on technical leadership skills with a track record of supporting on- the market products and delivering new products to market + Design for Six Sigma (DFSS) certification is desirable. + Prior experience leading & supporting projects that include managing external design, development, and manufacturing partners. + Prior technical leadership experience with creating design control/technical file deliverables and manufacturing scale-up a plus. + Proven track record of developing and gain regulatory approval of drug delivery systems a plus + Working knowledge of solid works desirable. **Key Skills and** **Competencies:** + A strong knowledge of developing and commercializing FDA regulated devices / combination products under Design Control regulations and ISO14971. + Extensive knowledge of engineering principles, concepts and applications. + Self-starter with strong planning and organizational skills. + An aptitude for project foresight and contingency planning. + Effective planning and organizational skills. + Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary audiences + Strong knowledge of project management techniques, tools and metrics. + Ability to mentor technical and cross functional team members. + Strong collaboration skills with external partners. **Other Job** **Components:** **Complexity and Problem** **Solving:** + Develops and implements novel approaches and tools for data collection, management, engineering, analysis, modeling, and interpretation. + Reviews, interprets data and communicates results with Pharm Sci functions and CMC team. Planning and implementation of solutions to project problem/issues + Coordinates tech transfer with vendors. + Stays updated on related technologies/methodologies and proposes options to implement within area of expertise + Drive the evaluation of complex drug delivery systems and provide sound technical recommendations to move projects forward. + Identify, communicate and lead device design control process evolution to meet device regulations. **Internal and External** **Contacts:** + Collaborate with commercial Product teams, Quality, Mfg, Regulatory, R&D, Clinical, Legal + Work closely with Contract Lab Organizations (CLOs), Contract Manufacturing Organizations (CMOs) + Communicates activities from their functional area to project teams (pipeline, non-pipeline, and functional initiatives) and requests functional area action from the project teams to senior leaders in their functional area. + Has authority as a technical project leader to commit available resources to execute specific project tasks for project teams (pipeline, non-pipeline, and functional initiatives) upon request + May fully represent their functional area to a project teams (pipeline, non-pipeline, and functional initiatives with narrow focus) May identify topics for functional initiatives + Work closely with external design, development and manufacturing partners **Functional training for multiple laboratory technologies:** + Develops and uses basic knowledge of cross functional departments to guide junior colleagues on impact of changes and inter- dependencies. + Develops expertise in multiple laboratory technologies and leverages as functional area resource and trainer. + May have responsibility for training/mentoring of junior colleagues **Takeda Compensation and Benefits Summary** We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. **For Location:** Lexington, MA **U.S. Base Salary Range:** $111,800.00 - $175,670.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** Lexington, MA **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time **Job Exempt** Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.