Director of Finance Job no: 536376 Work type: Staff Full-Time Location: Main Campus (Gainesville, FL) Categories: Business/Accounting/Finance, Executive/Director/Management Department: - PH-ADMINISTRATIVE FIN AFFAIRS Classification Title:Director of Finance Classification Minimum Requirements: Master's degree in appropriate area of specialization and six years of appropriate experience or a bachelor's degree in appropriate areas of specialization and eight years of experience. Job Description: Join Our Leadership Team Shape the Financial Future of the College of Pharmacy! Are you a strategic thinker with a passion for driving financial excellence? The University of Florida College of Pharmacy is seeking a dynamic Director of Finance to lead and shape our financial future. This pivotal role reports directly to the Dean and partners with senior leadership to align financial strategy with institutional priorities as we kick off our new five-year strategic plan. Budget and Financial Management: • Provide Financial Leadership • Lead and oversee financial operations across all college units • Offer strategic financial guidance aligned with the college's mission and goals Plan for Fiscal Sustainability • Direct short- and long-term financial planning to ensure stability • Advise the Dean and senior leadership on financial position, trends, risks, and opportunities including commitment tracking Develop & Implement Financial Strategy • Create comprehensive financial plans to support academic, research, and operational priorities • Ensure optimal resource allocation through data-informed planning Budget Management • Coordinate annual budgeting processes, including funding requests and reallocations • Oversee financial adjustments to support dynamic needs and priorities • Management of college incentive plans • Meet with individual department units to review program budget and future forecast • Provide detailed analysis and recommendations to improve financial planning and resource allocation Stewardship of Funds •Manage multiple funding streams: state appropriations, contracts and grants, UF Foundation, auxiliaries, student fees, and College of Pharmacy Faculty Practice Association accounts •Champion responsible, efficient financial stewardship that reflects institutional priorities • Policy Compliance & Communication • Interpret and apply financial policies from the university, state, and federal levels • Develop internal financial procedures and controls to maintain compliance and operational integrity Internal Support & Coordination • Act as a key resource for policy guidance and financial training • Collaborate with central UF offices Finance & Accounting, Contracts & Grants, Budget for policy alignment and consistency Financial Reporting and Compliance: • Directs preparation, review, and submission of internal and external financial reports, such as: • Variance reports • Forecasting summaries • Fund balances • Other reports required by university, state, or external entities • Ensures all reporting complies with university, state, and federal regulations and policies • Serves as the primary contact for financial audits and reviews by university, state, and independent auditors • Monitors financial transactions for accuracy, consistency, and integrity • Proactively investigates and resolves financial discrepancies and reporting issues • Oversight of annual auxiliary rate reviews Team Leadership: • Lead finance and logistics teams with strategic oversight and clear delegation • Align responsibilities with team strengths to ensure accountability and workflow efficiency • Guide performance through feedback, coaching, and professional development • Foster a collaborative, service-driven culture focused on growth and excellence • Ensure clear, consistent communication of expectations, timelines, and deliverables The University of Florida: UF, the flagship AAU institution of the State of Florida, is a top-tier research institution with a long history of training outstanding undergraduate, graduate, and professional students. UF is currently ranked among U.S. public universities by U.S. News and World Report. The University of Florida's academic health center is the country's only academic health center, with six health-related colleges located on a single, contiguous campus. The colleges, major research centers and institutes, and clinical enterprises focus on building collaborative, specialized clinical services centered on quality and innovation. The UF College of Pharmacy ranked by U.S. News & World Report as the No. 1 pharmacy college in Florida and the No. 4 pharmacy college nationally, the University of Florida College of Pharmacy has been developing future leaders in pharmacy practice and science for nearly a century. At campuses in Gainesville, Jacksonville and Orlando, award-winning faculty aim to improve the health of Floridians and people across the world through pharmacy education, high-impact research and clinical innovation. As one of the Top 3, National Institutes of Health-funded pharmacy colleges nationally, the UF College of Pharmacy features preeminent researchers who are leading major medical breakthroughs in areas such as drug discovery and development, pharmacometrics and systems pharmacology, and precision medicine. The college's online programs are among the largest and most successful in the world, having received multiple national awards for excellence in distance education. Why Gainesville? Gainesville is home to Florida's largest and oldest university, as well as a vibrant hub of education, healthcare, culture, and sports in the state. The University of Florida and UF Health Shands Hospital are major employers, providing jobs for many residents of surrounding counties. The Greater Gainesville area serves as the cultural, educational, and commercial heart of the north central Florida region. Gainesville offers a full range of municipal services, including cultural and administrative support. Renowned for its preservation of historic landmarks and natural beauty, the city boasts numerous parks, museums, and lakes that attract thousands of visitors. With its lush urban forest and Tree City USA designation, Gainesville stands out as one of Florida's most picturesque cities. Its central location provides convenient access to both coasts, offering easy exploration of Florida's famed beaches, springs, and nature reserves. Explore Gainesville in 60 Seconds. Expected Salary:Commensurate with education and experience. Employment Benefits include: • Health Insurance: UF participates in state- and university-sponsored benefits programs for individuals, families and domestic partners, and offers voluntary insurance that includes vision, dental, long-term disability and more. • Retirement Options: Attractive options include Florida Retirement System Pension Plan, State University System Optional Retirement Program, Florida Retirement System Investment Plan, and Voluntary Retirement Savings Plan. • Leave: UF Faculty and Staff enjoy a generous paid leave plan as well as access to a sick-leave pool, maternity/paternity leave, and leave payouts. To learn more visit: hr.ufl.edu/benefits Required Qualifications: •Master's degree in appropriate area of specialization and six years of appropriate experience or a bachelor's degree in appropriate areas of specialization and eight years of experience. Preferred: • Advanced degree in Finance, Accounting, or Business, MBA preferred • Experience in higher education and/or a health care environment • Have extensive experience and knowledge in strategic financial/budget management • Experience with PeopleSoft and/or Workday • Significant supervisory experience and the ability to effectively manage, coach, mentor and motivate others • Ability to work strategically, develop and implement constituency programs and activities • Must be an outstanding communicator and possess excellent written and verbal communication skills; interpersonal skills; and the ability to work collegially and interact effectively with a constituency • Have a proven ability to cultivate and maintain strong working relationships with internal and external leaders and organizations • Ability to work collaboratively and be a team player • Strong customer service focused mindset Special Instructions to Applicants: We welcome nominations of and applications for individuals who would bring unique perspectives and experiences to support UF's mission of excellence in education, research, and student life. Inquiries and nominations can be sent to Search Chair John Gums, PharmD () Candidates must apply online at Careers at UF. For full consideration, applications must be submitted by August 14, 2025 with the following required documents: • Cover Letter • Resume • List of references for at least three (3) professional contacts that includes: • Full name • Current position • Email address • Telephone number Applications received after July 21, 2025 will be reviewed at the discretion of the search panel. The position posting will remain open and accept applications until a competitive pool of applicants is established. This is primarily an on-campus leadership position with hybrid flexibility possible after a successful onboarding period. Health Assessment Required: No . click apply for full job details
10/21/2025
Full time
Director of Finance Job no: 536376 Work type: Staff Full-Time Location: Main Campus (Gainesville, FL) Categories: Business/Accounting/Finance, Executive/Director/Management Department: - PH-ADMINISTRATIVE FIN AFFAIRS Classification Title:Director of Finance Classification Minimum Requirements: Master's degree in appropriate area of specialization and six years of appropriate experience or a bachelor's degree in appropriate areas of specialization and eight years of experience. Job Description: Join Our Leadership Team Shape the Financial Future of the College of Pharmacy! Are you a strategic thinker with a passion for driving financial excellence? The University of Florida College of Pharmacy is seeking a dynamic Director of Finance to lead and shape our financial future. This pivotal role reports directly to the Dean and partners with senior leadership to align financial strategy with institutional priorities as we kick off our new five-year strategic plan. Budget and Financial Management: • Provide Financial Leadership • Lead and oversee financial operations across all college units • Offer strategic financial guidance aligned with the college's mission and goals Plan for Fiscal Sustainability • Direct short- and long-term financial planning to ensure stability • Advise the Dean and senior leadership on financial position, trends, risks, and opportunities including commitment tracking Develop & Implement Financial Strategy • Create comprehensive financial plans to support academic, research, and operational priorities • Ensure optimal resource allocation through data-informed planning Budget Management • Coordinate annual budgeting processes, including funding requests and reallocations • Oversee financial adjustments to support dynamic needs and priorities • Management of college incentive plans • Meet with individual department units to review program budget and future forecast • Provide detailed analysis and recommendations to improve financial planning and resource allocation Stewardship of Funds •Manage multiple funding streams: state appropriations, contracts and grants, UF Foundation, auxiliaries, student fees, and College of Pharmacy Faculty Practice Association accounts •Champion responsible, efficient financial stewardship that reflects institutional priorities • Policy Compliance & Communication • Interpret and apply financial policies from the university, state, and federal levels • Develop internal financial procedures and controls to maintain compliance and operational integrity Internal Support & Coordination • Act as a key resource for policy guidance and financial training • Collaborate with central UF offices Finance & Accounting, Contracts & Grants, Budget for policy alignment and consistency Financial Reporting and Compliance: • Directs preparation, review, and submission of internal and external financial reports, such as: • Variance reports • Forecasting summaries • Fund balances • Other reports required by university, state, or external entities • Ensures all reporting complies with university, state, and federal regulations and policies • Serves as the primary contact for financial audits and reviews by university, state, and independent auditors • Monitors financial transactions for accuracy, consistency, and integrity • Proactively investigates and resolves financial discrepancies and reporting issues • Oversight of annual auxiliary rate reviews Team Leadership: • Lead finance and logistics teams with strategic oversight and clear delegation • Align responsibilities with team strengths to ensure accountability and workflow efficiency • Guide performance through feedback, coaching, and professional development • Foster a collaborative, service-driven culture focused on growth and excellence • Ensure clear, consistent communication of expectations, timelines, and deliverables The University of Florida: UF, the flagship AAU institution of the State of Florida, is a top-tier research institution with a long history of training outstanding undergraduate, graduate, and professional students. UF is currently ranked among U.S. public universities by U.S. News and World Report. The University of Florida's academic health center is the country's only academic health center, with six health-related colleges located on a single, contiguous campus. The colleges, major research centers and institutes, and clinical enterprises focus on building collaborative, specialized clinical services centered on quality and innovation. The UF College of Pharmacy ranked by U.S. News & World Report as the No. 1 pharmacy college in Florida and the No. 4 pharmacy college nationally, the University of Florida College of Pharmacy has been developing future leaders in pharmacy practice and science for nearly a century. At campuses in Gainesville, Jacksonville and Orlando, award-winning faculty aim to improve the health of Floridians and people across the world through pharmacy education, high-impact research and clinical innovation. As one of the Top 3, National Institutes of Health-funded pharmacy colleges nationally, the UF College of Pharmacy features preeminent researchers who are leading major medical breakthroughs in areas such as drug discovery and development, pharmacometrics and systems pharmacology, and precision medicine. The college's online programs are among the largest and most successful in the world, having received multiple national awards for excellence in distance education. Why Gainesville? Gainesville is home to Florida's largest and oldest university, as well as a vibrant hub of education, healthcare, culture, and sports in the state. The University of Florida and UF Health Shands Hospital are major employers, providing jobs for many residents of surrounding counties. The Greater Gainesville area serves as the cultural, educational, and commercial heart of the north central Florida region. Gainesville offers a full range of municipal services, including cultural and administrative support. Renowned for its preservation of historic landmarks and natural beauty, the city boasts numerous parks, museums, and lakes that attract thousands of visitors. With its lush urban forest and Tree City USA designation, Gainesville stands out as one of Florida's most picturesque cities. Its central location provides convenient access to both coasts, offering easy exploration of Florida's famed beaches, springs, and nature reserves. Explore Gainesville in 60 Seconds. Expected Salary:Commensurate with education and experience. Employment Benefits include: • Health Insurance: UF participates in state- and university-sponsored benefits programs for individuals, families and domestic partners, and offers voluntary insurance that includes vision, dental, long-term disability and more. • Retirement Options: Attractive options include Florida Retirement System Pension Plan, State University System Optional Retirement Program, Florida Retirement System Investment Plan, and Voluntary Retirement Savings Plan. • Leave: UF Faculty and Staff enjoy a generous paid leave plan as well as access to a sick-leave pool, maternity/paternity leave, and leave payouts. To learn more visit: hr.ufl.edu/benefits Required Qualifications: •Master's degree in appropriate area of specialization and six years of appropriate experience or a bachelor's degree in appropriate areas of specialization and eight years of experience. Preferred: • Advanced degree in Finance, Accounting, or Business, MBA preferred • Experience in higher education and/or a health care environment • Have extensive experience and knowledge in strategic financial/budget management • Experience with PeopleSoft and/or Workday • Significant supervisory experience and the ability to effectively manage, coach, mentor and motivate others • Ability to work strategically, develop and implement constituency programs and activities • Must be an outstanding communicator and possess excellent written and verbal communication skills; interpersonal skills; and the ability to work collegially and interact effectively with a constituency • Have a proven ability to cultivate and maintain strong working relationships with internal and external leaders and organizations • Ability to work collaboratively and be a team player • Strong customer service focused mindset Special Instructions to Applicants: We welcome nominations of and applications for individuals who would bring unique perspectives and experiences to support UF's mission of excellence in education, research, and student life. Inquiries and nominations can be sent to Search Chair John Gums, PharmD () Candidates must apply online at Careers at UF. For full consideration, applications must be submitted by August 14, 2025 with the following required documents: • Cover Letter • Resume • List of references for at least three (3) professional contacts that includes: • Full name • Current position • Email address • Telephone number Applications received after July 21, 2025 will be reviewed at the discretion of the search panel. The position posting will remain open and accept applications until a competitive pool of applicants is established. This is primarily an on-campus leadership position with hybrid flexibility possible after a successful onboarding period. Health Assessment Required: No . click apply for full job details
ATSU - Post-Award Project Manager Job Type Full-time Description A.T. Still University (ATSU) is seeking a full-time exempt Post-Award Project Manager on the Kirksville, Missouri campus. The post-award project manager position will be a professional member of and work collaboratively with the award-winning ATSU SP team, yet may be assigned to a designated ATSU grant project director/principal investigator (likely affiliated with an ATSU school/department outside of SP). The purpose of this position is to ensure the timely and compliant management and implementation of a funded sponsored project(s) of broad scope and high priority. Duties & Responsibilities: The post-award project manager will collaborate with the designated project director(s)/principal investigator(s) to lead appropriate and timely accomplishment of all funded sponsored project activities. To this end, the post-award project manager will work, on a day-to-day basis, with the PD/PI to: Convene/conduct project advisory committee meetings, subcommittee/team meetings, and other grant-funded or grant-specific events. Assess and secure grant-specific facilities, equipment, and other resources to accomplish all grant-funded goals, objectives, and activities. Manage, oversee, and track travel and other requirements for both internal and external project personnel. Create or collaborate with faculty, staff, external consultants, and guest faculty in the production, delivery, and assessment of relevant academic/project-specific materials. Work alongside project leaders/faculty to develop and implement needs/interest surveys for pre- and post-assessment of related sponsored project activities, as well as assist in compiling related data for analyses. Track and report on all sponsored project data, outcomes, etc., being accountable to the PD/PI, ATSU SP, and ultimately the external sponsor of the grant. Collaborate with the PD/PI in co-authoring project-related manuscripts, publications, and other dissemination work. Oversee and manage all programmatic and budgetary compliance specific to the designated sponsored project(s). Monitor emerging policy guidance and participate in funding source and industry technical assistance calls/webinars. Lead in the preparation of progress reports, competing/continuation grant applications, and other required grant reports/documents, including the management of participant demographic data, tables, spreadsheets, etc. Learn required electronic reporting systems and continually improve the use of digital artifacts. Facilitate, activate, and oversee the grant budget, expenditures, and sub-awards/contracts. Provide subrecipient monitoring and oversight as required by policy. Assist project director(s)/principal investigator(s) and the University's sponsored programs team in identifying emerging program priorities/needs and developing complementary grant proposals. Identify emerging opportunities for intra-institution collaboration. Requirements Education & Experience: Bachelor's degree in Education, Business, Health Education, etc., required or the equivalent combination of education/experience from which comparable knowledge and abilities are acquired. Master's degree a plus. The post-award project manager should have experience (1) with project/grants management; budgeting/accounting; data tracking/assessment, competitive/technical writing, program development, proofreading, and editing; (2) in a highly productive and sometimes stressful environment; (3) working independently and in a team environment; and (4) with managing multiple deadlines and priorities. Familiarity with higher education/academic medicine and/or health care/research environment is beneficial. Previous publishing/writing is desirable but not mandatory. The position requires excellent writing, editing, and abstracting for scholarly work and presentations, as well as reporting/continuation applications. Ability to understand/interpret complex policy, guidance, and funding source requirements needed. The position also requires excellent software knowledge/capability (Microsoft Word, Excel, Access, PowerPoint, GMail, Adobe, etc.), a high proficiency in searching and conducting research via the Internet, and organization in creating, handling, and managing digital grant reports/applications. Work Location: Kirksville, MO, campus with potential for telecommuting. Occasional travel to professional meetings/conferences may be necessary. ATSU offers a comprehensive benefits package including medical, dental, and vision coverages, among more. If eligible, employee-elected benefits would begin the first of the month following hire date. For more information, please visit: atsu.edu/employment/benefits . A.T. Still University (ATSU) does not discriminate on the basis of race, color, religion, ethnicity, national origin, sex (including pregnancy), sexual orientation, age, disability, or veteran status in admission or access to, or treatment or employment in its programs and activities. To apply, visit Copyright 2025 Inc. All rights reserved. Posted by the FREE value-added recruitment advertising agency jeid-a4d94db5790b264bae78d0e470d6d530
10/20/2025
Full time
ATSU - Post-Award Project Manager Job Type Full-time Description A.T. Still University (ATSU) is seeking a full-time exempt Post-Award Project Manager on the Kirksville, Missouri campus. The post-award project manager position will be a professional member of and work collaboratively with the award-winning ATSU SP team, yet may be assigned to a designated ATSU grant project director/principal investigator (likely affiliated with an ATSU school/department outside of SP). The purpose of this position is to ensure the timely and compliant management and implementation of a funded sponsored project(s) of broad scope and high priority. Duties & Responsibilities: The post-award project manager will collaborate with the designated project director(s)/principal investigator(s) to lead appropriate and timely accomplishment of all funded sponsored project activities. To this end, the post-award project manager will work, on a day-to-day basis, with the PD/PI to: Convene/conduct project advisory committee meetings, subcommittee/team meetings, and other grant-funded or grant-specific events. Assess and secure grant-specific facilities, equipment, and other resources to accomplish all grant-funded goals, objectives, and activities. Manage, oversee, and track travel and other requirements for both internal and external project personnel. Create or collaborate with faculty, staff, external consultants, and guest faculty in the production, delivery, and assessment of relevant academic/project-specific materials. Work alongside project leaders/faculty to develop and implement needs/interest surveys for pre- and post-assessment of related sponsored project activities, as well as assist in compiling related data for analyses. Track and report on all sponsored project data, outcomes, etc., being accountable to the PD/PI, ATSU SP, and ultimately the external sponsor of the grant. Collaborate with the PD/PI in co-authoring project-related manuscripts, publications, and other dissemination work. Oversee and manage all programmatic and budgetary compliance specific to the designated sponsored project(s). Monitor emerging policy guidance and participate in funding source and industry technical assistance calls/webinars. Lead in the preparation of progress reports, competing/continuation grant applications, and other required grant reports/documents, including the management of participant demographic data, tables, spreadsheets, etc. Learn required electronic reporting systems and continually improve the use of digital artifacts. Facilitate, activate, and oversee the grant budget, expenditures, and sub-awards/contracts. Provide subrecipient monitoring and oversight as required by policy. Assist project director(s)/principal investigator(s) and the University's sponsored programs team in identifying emerging program priorities/needs and developing complementary grant proposals. Identify emerging opportunities for intra-institution collaboration. Requirements Education & Experience: Bachelor's degree in Education, Business, Health Education, etc., required or the equivalent combination of education/experience from which comparable knowledge and abilities are acquired. Master's degree a plus. The post-award project manager should have experience (1) with project/grants management; budgeting/accounting; data tracking/assessment, competitive/technical writing, program development, proofreading, and editing; (2) in a highly productive and sometimes stressful environment; (3) working independently and in a team environment; and (4) with managing multiple deadlines and priorities. Familiarity with higher education/academic medicine and/or health care/research environment is beneficial. Previous publishing/writing is desirable but not mandatory. The position requires excellent writing, editing, and abstracting for scholarly work and presentations, as well as reporting/continuation applications. Ability to understand/interpret complex policy, guidance, and funding source requirements needed. The position also requires excellent software knowledge/capability (Microsoft Word, Excel, Access, PowerPoint, GMail, Adobe, etc.), a high proficiency in searching and conducting research via the Internet, and organization in creating, handling, and managing digital grant reports/applications. Work Location: Kirksville, MO, campus with potential for telecommuting. Occasional travel to professional meetings/conferences may be necessary. ATSU offers a comprehensive benefits package including medical, dental, and vision coverages, among more. If eligible, employee-elected benefits would begin the first of the month following hire date. For more information, please visit: atsu.edu/employment/benefits . A.T. Still University (ATSU) does not discriminate on the basis of race, color, religion, ethnicity, national origin, sex (including pregnancy), sexual orientation, age, disability, or veteran status in admission or access to, or treatment or employment in its programs and activities. To apply, visit Copyright 2025 Inc. All rights reserved. Posted by the FREE value-added recruitment advertising agency jeid-a4d94db5790b264bae78d0e470d6d530
Job Title : Senior Director, Transplant Access Strategy and Provider Accounts Location: Cambridge MA or Morristown, NJ About the Job The Sr Director, Transplant Market Access Strategy & Provider Accounts will lead a small team and be responsible for developing and implementing the short and long-term transplant market access strategy (positioning, pricing, contracting, pull-through plans) from start to end, for national/regional payers, institutions, channel customers, and patient support services. The candidate will utilize portfolio expertise and managed markets experience to build an integrated market access strategy based upon the brands strategies. The ability to identify key customer segments and generate customer insights is critical in this role. In addition, the role will define & implement inline and launch indication pricing strategy, MAx strategy, plan/tools, based on the global brand strategies. The incumbent will be responsible for transversally leading across diverse teams including Marketing, Market Access Shared Services, HEVA/RWE, PSS, Trade, Finance, Legal, manufacturing and logistics, and field sales. The candidate must have strong business acumen and outstanding communication and interpersonal skills to develop productive relationships across all internal and external customer groups. We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue progress to make a real impact on millions of patients around the world. Main Responsibilities: Partner effectively with support functions, Global Market Access and US teams to execute on MAx core deliverables (ex. specific market access or other tools). Represent the access customer perspective within cross-functional, cross-regional commercialization teams including Brand, USMA, HEVA/RWE, Market Access Shared Services, PSS, Trade, Finance, Communications, Policy/Advocacy, and Public Affairs thereby optimizing the lifecycle of transplant products. Partner with relevant departments (as listed above) to influence the market assessment, product positioning, and target product profile by providing strategic input regarding market access, reimbursement, and pricing information throughout the product lifecycle. Participate in account discussions, as necessary, to communicate brand value, strategies, and market dynamics as they impact the product. As a part of the broader global market access community, work closely with access professionals across the world ensuring consistent feedback and optimization of Global Value and Access deliverables including launch preparation, negotiations training, and contracting (including value-based and outcomes-based frameworks). Develop market access strategies for future indications including generation of pricing recommendation, value proposition and messages, and detailed forecast assumptions, support strategies within depth market research, and environmental data & analogs as appropriate. Partner closely with marketing on the assessment of business development/divestiture opportunities. Monitor the marketplace for market access challenges, trends, threats & opportunities. Partner closely with market access strategy colleagues within BU and across the organization to share best practices, customer insights and emerging trends. About You Basic Qualifications: BA/BS and 10+ years' relevant professional experience including market access, health economics, pricing & reimbursement 10+ years' experience at local and/or international level w/ knowledge of US and Global market access & payer environment Knowledge of disease market access desirable, but other backgrounds are welcomed. Preferred Qualifications: Proven track record of leading within a matrix environment to reach business objectives Demonstrated ability to take on highly complex business problems, recommend strategic and tactical solutions in a simple and straightforward manner Exhibits outstanding written and oral communication skills, including the ability to effectively write and deliver presentations to professionals at all levels within Sanofi Demonstrated relationship building and team management at all levels of the organization and across geographies Travel: Approximately 10-20% The successful candidate will be required to sign and execute a restricted covenant upon hire. 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
10/20/2025
Full time
Job Title : Senior Director, Transplant Access Strategy and Provider Accounts Location: Cambridge MA or Morristown, NJ About the Job The Sr Director, Transplant Market Access Strategy & Provider Accounts will lead a small team and be responsible for developing and implementing the short and long-term transplant market access strategy (positioning, pricing, contracting, pull-through plans) from start to end, for national/regional payers, institutions, channel customers, and patient support services. The candidate will utilize portfolio expertise and managed markets experience to build an integrated market access strategy based upon the brands strategies. The ability to identify key customer segments and generate customer insights is critical in this role. In addition, the role will define & implement inline and launch indication pricing strategy, MAx strategy, plan/tools, based on the global brand strategies. The incumbent will be responsible for transversally leading across diverse teams including Marketing, Market Access Shared Services, HEVA/RWE, PSS, Trade, Finance, Legal, manufacturing and logistics, and field sales. The candidate must have strong business acumen and outstanding communication and interpersonal skills to develop productive relationships across all internal and external customer groups. We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue progress to make a real impact on millions of patients around the world. Main Responsibilities: Partner effectively with support functions, Global Market Access and US teams to execute on MAx core deliverables (ex. specific market access or other tools). Represent the access customer perspective within cross-functional, cross-regional commercialization teams including Brand, USMA, HEVA/RWE, Market Access Shared Services, PSS, Trade, Finance, Communications, Policy/Advocacy, and Public Affairs thereby optimizing the lifecycle of transplant products. Partner with relevant departments (as listed above) to influence the market assessment, product positioning, and target product profile by providing strategic input regarding market access, reimbursement, and pricing information throughout the product lifecycle. Participate in account discussions, as necessary, to communicate brand value, strategies, and market dynamics as they impact the product. As a part of the broader global market access community, work closely with access professionals across the world ensuring consistent feedback and optimization of Global Value and Access deliverables including launch preparation, negotiations training, and contracting (including value-based and outcomes-based frameworks). Develop market access strategies for future indications including generation of pricing recommendation, value proposition and messages, and detailed forecast assumptions, support strategies within depth market research, and environmental data & analogs as appropriate. Partner closely with marketing on the assessment of business development/divestiture opportunities. Monitor the marketplace for market access challenges, trends, threats & opportunities. Partner closely with market access strategy colleagues within BU and across the organization to share best practices, customer insights and emerging trends. About You Basic Qualifications: BA/BS and 10+ years' relevant professional experience including market access, health economics, pricing & reimbursement 10+ years' experience at local and/or international level w/ knowledge of US and Global market access & payer environment Knowledge of disease market access desirable, but other backgrounds are welcomed. Preferred Qualifications: Proven track record of leading within a matrix environment to reach business objectives Demonstrated ability to take on highly complex business problems, recommend strategic and tactical solutions in a simple and straightforward manner Exhibits outstanding written and oral communication skills, including the ability to effectively write and deliver presentations to professionals at all levels within Sanofi Demonstrated relationship building and team management at all levels of the organization and across geographies Travel: Approximately 10-20% The successful candidate will be required to sign and execute a restricted covenant upon hire. 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job Title: Associate Director-Principal Medical Writer Location: USA, Remote. Proximity to Cambridge/Boston, MA or Morristown, NJ is highly desirable for attending occasional team meetings 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. The Principal Medical Writer is a key member of the Medical Writing team, the Clinical Trial Team (CTT) and Project Team. This is a position for a senior medical writer who has an extensive experience with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission lead. As an integral part of the clinical team, the position holder ensures the quality, compliance with internal and external standards, and timely production of English-language clinical documents regarding both the project as a whole, and individual clinical studies. Our Team: Global Medical writing and Document management serves to generate timely, high quality, cost effective and regulatory compliant documents. Our mission is to synergize and harness evolving technologies pushing the edge of regulatory writing. 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: More specifically the position holder, is responsible for the timely preparation and/or coordination, in English, of reports and/or related regulatory documentation (in some cases of extremely time-critical documentation), required for the planning, initiation, performance and reporting of clinical studies and for marketing approvals worldwide. This work involves close cooperation with members of the CTT and Project Team, as well as colleagues within Clinical Documentation. must provide dedicated scientific authoring expertise to ensure that the clinical opinion, as defined by the Clinical Study Director and the Therapeutic Department Head, is presented accurately and concisely. may need to liaise with external services and review documentation generated elsewhere (e.g. Clinical Research Organisations (CROs), subsidiaries, co-development partners), and internal support staff (e.g. for the preparation of tables, illustrations and appendices). in addition to bringing the required medical writing skills and industry experience, must be willing and able to take responsibility for the mentoring and/or training of more junior colleagues, management of Clinical Documentation teams, maintaining close contact with external departments, and the coordination of external contractors. In addition, he/she is the Clinical Documentation representative in transversal initiatives to contribute to the implementation of process improvement. He /she leads projects in view of developing innovative solutions and technologies (e.g. content re-use, AI) to bring efficiencies and cost savings. He/she contributes to training preparation and delivery, and provides support to the medical writing teams. Principal duties and responsibilities Produce and update clinical documents in a timely manner for study start, conduct and completion, as well as regulatory submissions according to company standards and procedures with the ultimate aim to gain regulatory approval of therapeutic indications. Coordinate medical writing activities in study teams, including external services. Ensure information sharing among MWs. Submit suggestions for improving or extending the standards of clinical documentation, share experience with other medical writers of accommodating special details of clinical studies not covered by the standards and technical expertise gained with advanced technologies. Review clinical development plans to ensure adequate planning of medical writing activities. Advise team members of regulatory requirements for documentation and propose strategies that provide efficiency gains. Prepare or coordinate the preparation of clinical modules for registration dossier, including overall EU or US clinical regulatory documentation using available standards, and ensure consistency across regulatory documents following database changes or modifications to the registration package. Prepare or coordinate the preparation of responses regarding company drug submission dossiers to Health Authorities. Review and edit work of contract writers to ensure quality is maintained. Build and sustain rapport with clinical personnel, including internal clients and colleagues. Establish effective cross-functional relationships with local and counterparts in other departments, especially Regulatory Operations. Maintain awareness of current clinical documentation requirements for target regulatory agencies. Notify management of any changes to standards and the impact of these changes on systems/processes. Represent Clinical Documentation as Subject Matter Expert on transversal initiatives, concerning content, processes and tools for the implementation of new/updated processes or IT solutions to bring efficiencies, time and/or cost saving. Acts as change agent for the medical writing teams. Share experience with and train other medical writers. In collaboration with ITS, lead transversal project teams in view of the implementation of new technologies for accelerating the preparation of the documents and providing cost saving. About You Knowledge and skills An experience as a Medical Writer of at least 6 years, or equivalent. Ability to clearly, accurately, and concisely prepare all types of clinical documentation, including major submission and/or complex documents in English. Excellent interpersonal and leadership skills. Ability to work both autonomously and collaboratively with transversal teams in a multicultural, multilingual, and geographically dispersed environment. Must be deadline oriented, possesing a sense of urgency, accuracy, and be meticulous and attentive to detail. Technical comfort with electronic document management and word processing software is required, particularly good Microsoft Word skills. Keen interest in exploring and implementing emerging innovative digital technologies, including content reuse strategies and AI-assisted document authoring solutions. Native English speaker or with proven excellent spoken and written English. Possesses a solid work ethic, professionalism, organizational ability, and follow-up skills Formal Education And/or Experience required Advanced scientific degree, Master or Ph.D. in life sciences, PharmD, or medically qualified. Work experience of more than 6 years as a medical writer or equivalent, or presenting relevant specialist qualifications. Experience as Lead Project MW on multiple types of clinical documents. Professional background documenting an excellent understanding of, and experience in, clinical development, including clinical study performance/methodology, basic statistics, and/or the regulatory environment. Knowledge and skill desirable but non-essential Specific knowledge of company-targeted therapeutic areas is strongly desirable. 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. 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. . click apply for full job details
10/20/2025
Full time
Job Title: Associate Director-Principal Medical Writer Location: USA, Remote. Proximity to Cambridge/Boston, MA or Morristown, NJ is highly desirable for attending occasional team meetings 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. The Principal Medical Writer is a key member of the Medical Writing team, the Clinical Trial Team (CTT) and Project Team. This is a position for a senior medical writer who has an extensive experience with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission lead. As an integral part of the clinical team, the position holder ensures the quality, compliance with internal and external standards, and timely production of English-language clinical documents regarding both the project as a whole, and individual clinical studies. Our Team: Global Medical writing and Document management serves to generate timely, high quality, cost effective and regulatory compliant documents. Our mission is to synergize and harness evolving technologies pushing the edge of regulatory writing. 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: More specifically the position holder, is responsible for the timely preparation and/or coordination, in English, of reports and/or related regulatory documentation (in some cases of extremely time-critical documentation), required for the planning, initiation, performance and reporting of clinical studies and for marketing approvals worldwide. This work involves close cooperation with members of the CTT and Project Team, as well as colleagues within Clinical Documentation. must provide dedicated scientific authoring expertise to ensure that the clinical opinion, as defined by the Clinical Study Director and the Therapeutic Department Head, is presented accurately and concisely. may need to liaise with external services and review documentation generated elsewhere (e.g. Clinical Research Organisations (CROs), subsidiaries, co-development partners), and internal support staff (e.g. for the preparation of tables, illustrations and appendices). in addition to bringing the required medical writing skills and industry experience, must be willing and able to take responsibility for the mentoring and/or training of more junior colleagues, management of Clinical Documentation teams, maintaining close contact with external departments, and the coordination of external contractors. In addition, he/she is the Clinical Documentation representative in transversal initiatives to contribute to the implementation of process improvement. He /she leads projects in view of developing innovative solutions and technologies (e.g. content re-use, AI) to bring efficiencies and cost savings. He/she contributes to training preparation and delivery, and provides support to the medical writing teams. Principal duties and responsibilities Produce and update clinical documents in a timely manner for study start, conduct and completion, as well as regulatory submissions according to company standards and procedures with the ultimate aim to gain regulatory approval of therapeutic indications. Coordinate medical writing activities in study teams, including external services. Ensure information sharing among MWs. Submit suggestions for improving or extending the standards of clinical documentation, share experience with other medical writers of accommodating special details of clinical studies not covered by the standards and technical expertise gained with advanced technologies. Review clinical development plans to ensure adequate planning of medical writing activities. Advise team members of regulatory requirements for documentation and propose strategies that provide efficiency gains. Prepare or coordinate the preparation of clinical modules for registration dossier, including overall EU or US clinical regulatory documentation using available standards, and ensure consistency across regulatory documents following database changes or modifications to the registration package. Prepare or coordinate the preparation of responses regarding company drug submission dossiers to Health Authorities. Review and edit work of contract writers to ensure quality is maintained. Build and sustain rapport with clinical personnel, including internal clients and colleagues. Establish effective cross-functional relationships with local and counterparts in other departments, especially Regulatory Operations. Maintain awareness of current clinical documentation requirements for target regulatory agencies. Notify management of any changes to standards and the impact of these changes on systems/processes. Represent Clinical Documentation as Subject Matter Expert on transversal initiatives, concerning content, processes and tools for the implementation of new/updated processes or IT solutions to bring efficiencies, time and/or cost saving. Acts as change agent for the medical writing teams. Share experience with and train other medical writers. In collaboration with ITS, lead transversal project teams in view of the implementation of new technologies for accelerating the preparation of the documents and providing cost saving. About You Knowledge and skills An experience as a Medical Writer of at least 6 years, or equivalent. Ability to clearly, accurately, and concisely prepare all types of clinical documentation, including major submission and/or complex documents in English. Excellent interpersonal and leadership skills. Ability to work both autonomously and collaboratively with transversal teams in a multicultural, multilingual, and geographically dispersed environment. Must be deadline oriented, possesing a sense of urgency, accuracy, and be meticulous and attentive to detail. Technical comfort with electronic document management and word processing software is required, particularly good Microsoft Word skills. Keen interest in exploring and implementing emerging innovative digital technologies, including content reuse strategies and AI-assisted document authoring solutions. Native English speaker or with proven excellent spoken and written English. Possesses a solid work ethic, professionalism, organizational ability, and follow-up skills Formal Education And/or Experience required Advanced scientific degree, Master or Ph.D. in life sciences, PharmD, or medically qualified. Work experience of more than 6 years as a medical writer or equivalent, or presenting relevant specialist qualifications. Experience as Lead Project MW on multiple types of clinical documents. Professional background documenting an excellent understanding of, and experience in, clinical development, including clinical study performance/methodology, basic statistics, and/or the regulatory environment. Knowledge and skill desirable but non-essential Specific knowledge of company-targeted therapeutic areas is strongly desirable. 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. 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. . click apply for full job details
Job Title : Senior Director, Transplant Access Strategy and Provider Accounts Location: Cambridge MA or Morristown, NJ About the Job The Sr Director, Transplant Market Access Strategy & Provider Accounts will lead a small team and be responsible for developing and implementing the short and long-term transplant market access strategy (positioning, pricing, contracting, pull-through plans) from start to end, for national/regional payers, institutions, channel customers, and patient support services. The candidate will utilize portfolio expertise and managed markets experience to build an integrated market access strategy based upon the brands strategies. The ability to identify key customer segments and generate customer insights is critical in this role. In addition, the role will define & implement inline and launch indication pricing strategy, MAx strategy, plan/tools, based on the global brand strategies. The incumbent will be responsible for transversally leading across diverse teams including Marketing, Market Access Shared Services, HEVA/RWE, PSS, Trade, Finance, Legal, manufacturing and logistics, and field sales. The candidate must have strong business acumen and outstanding communication and interpersonal skills to develop productive relationships across all internal and external customer groups. We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue progress to make a real impact on millions of patients around the world. Main Responsibilities: Partner effectively with support functions, Global Market Access and US teams to execute on MAx core deliverables (ex. specific market access or other tools). Represent the access customer perspective within cross-functional, cross-regional commercialization teams including Brand, USMA, HEVA/RWE, Market Access Shared Services, PSS, Trade, Finance, Communications, Policy/Advocacy, and Public Affairs thereby optimizing the lifecycle of transplant products. Partner with relevant departments (as listed above) to influence the market assessment, product positioning, and target product profile by providing strategic input regarding market access, reimbursement, and pricing information throughout the product lifecycle. Participate in account discussions, as necessary, to communicate brand value, strategies, and market dynamics as they impact the product. As a part of the broader global market access community, work closely with access professionals across the world ensuring consistent feedback and optimization of Global Value and Access deliverables including launch preparation, negotiations training, and contracting (including value-based and outcomes-based frameworks). Develop market access strategies for future indications including generation of pricing recommendation, value proposition and messages, and detailed forecast assumptions, support strategies within depth market research, and environmental data & analogs as appropriate. Partner closely with marketing on the assessment of business development/divestiture opportunities. Monitor the marketplace for market access challenges, trends, threats & opportunities. Partner closely with market access strategy colleagues within BU and across the organization to share best practices, customer insights and emerging trends. About You Basic Qualifications: BA/BS and 10+ years' relevant professional experience including market access, health economics, pricing & reimbursement 10+ years' experience at local and/or international level w/ knowledge of US and Global market access & payer environment Knowledge of disease market access desirable, but other backgrounds are welcomed. Preferred Qualifications: Proven track record of leading within a matrix environment to reach business objectives Demonstrated ability to take on highly complex business problems, recommend strategic and tactical solutions in a simple and straightforward manner Exhibits outstanding written and oral communication skills, including the ability to effectively write and deliver presentations to professionals at all levels within Sanofi Demonstrated relationship building and team management at all levels of the organization and across geographies Travel: Approximately 10-20% The successful candidate will be required to sign and execute a restricted covenant upon hire. 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
10/20/2025
Full time
Job Title : Senior Director, Transplant Access Strategy and Provider Accounts Location: Cambridge MA or Morristown, NJ About the Job The Sr Director, Transplant Market Access Strategy & Provider Accounts will lead a small team and be responsible for developing and implementing the short and long-term transplant market access strategy (positioning, pricing, contracting, pull-through plans) from start to end, for national/regional payers, institutions, channel customers, and patient support services. The candidate will utilize portfolio expertise and managed markets experience to build an integrated market access strategy based upon the brands strategies. The ability to identify key customer segments and generate customer insights is critical in this role. In addition, the role will define & implement inline and launch indication pricing strategy, MAx strategy, plan/tools, based on the global brand strategies. The incumbent will be responsible for transversally leading across diverse teams including Marketing, Market Access Shared Services, HEVA/RWE, PSS, Trade, Finance, Legal, manufacturing and logistics, and field sales. The candidate must have strong business acumen and outstanding communication and interpersonal skills to develop productive relationships across all internal and external customer groups. We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue progress to make a real impact on millions of patients around the world. Main Responsibilities: Partner effectively with support functions, Global Market Access and US teams to execute on MAx core deliverables (ex. specific market access or other tools). Represent the access customer perspective within cross-functional, cross-regional commercialization teams including Brand, USMA, HEVA/RWE, Market Access Shared Services, PSS, Trade, Finance, Communications, Policy/Advocacy, and Public Affairs thereby optimizing the lifecycle of transplant products. Partner with relevant departments (as listed above) to influence the market assessment, product positioning, and target product profile by providing strategic input regarding market access, reimbursement, and pricing information throughout the product lifecycle. Participate in account discussions, as necessary, to communicate brand value, strategies, and market dynamics as they impact the product. As a part of the broader global market access community, work closely with access professionals across the world ensuring consistent feedback and optimization of Global Value and Access deliverables including launch preparation, negotiations training, and contracting (including value-based and outcomes-based frameworks). Develop market access strategies for future indications including generation of pricing recommendation, value proposition and messages, and detailed forecast assumptions, support strategies within depth market research, and environmental data & analogs as appropriate. Partner closely with marketing on the assessment of business development/divestiture opportunities. Monitor the marketplace for market access challenges, trends, threats & opportunities. Partner closely with market access strategy colleagues within BU and across the organization to share best practices, customer insights and emerging trends. About You Basic Qualifications: BA/BS and 10+ years' relevant professional experience including market access, health economics, pricing & reimbursement 10+ years' experience at local and/or international level w/ knowledge of US and Global market access & payer environment Knowledge of disease market access desirable, but other backgrounds are welcomed. Preferred Qualifications: Proven track record of leading within a matrix environment to reach business objectives Demonstrated ability to take on highly complex business problems, recommend strategic and tactical solutions in a simple and straightforward manner Exhibits outstanding written and oral communication skills, including the ability to effectively write and deliver presentations to professionals at all levels within Sanofi Demonstrated relationship building and team management at all levels of the organization and across geographies Travel: Approximately 10-20% The successful candidate will be required to sign and execute a restricted covenant upon hire. 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job Title: Associate Director, Marketing - Alpha-1 Antitrypsin Deficiency Launch Location: Cambridge, MA About the Job The Associate Director, Marketing - Alpha-1 Antitrypsin Deficiency Launch will be responsible for supporting unbranded and branded efforts for INBRX-101, which is expected to be the first innovative medicine in the AATD space in several years. The role will work closely with the US and global brand teams, as well as with the US Go-to-Market Capabilities (GTMC) team to create and drive clear and data-driven action plans. The successful candidate will support the market development strategy-leveraging digital tools and analytics-and promotional strategy-ensuring the pull-through of strategic differentiators into patient, account, and health systems channels. This position will report to the Alpha-1 Antitrypsin Deficiency US Launch Lead, and will be based in Cambridge, MA. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Main Responsibilities Support the development and execution of the US commercial strategy for the INBRX-101 launch Create and drive clear and data-driven market development and promotional action plans Collaborate extensively with marketing, GTMC, and other functions to ensure we achieve key milestones and targets Manage external vendor relationships and budgets to ensure effective execution of strategy and tactical plan About You Bachelor degree required, MBA a plus Minimum of 5+ years of progressive experience marketing in pharmaceutical/biotech commercial teams with a minimum of 2 years of experience marketing and launching drugs in the U.S. required Specialty therapeutic and immunology experience strongly preferred Ability to leverage insights and analytics in the development of clear and data-driven action plans; a thinker who is both big picture as well as detail-oriented with a strong sense of urgency Demonstrated ability to autonomously lead, prioritize, and manage multiple projects from start to finish, and effectively collaborate and engage with internal and external partners Knowledge of the Legal and Regulatory landscape pertaining to pharmaceutical marketing; including Medical/Legal/Regulatory Review Committee process 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 a 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
10/20/2025
Full time
Job Title: Associate Director, Marketing - Alpha-1 Antitrypsin Deficiency Launch Location: Cambridge, MA About the Job The Associate Director, Marketing - Alpha-1 Antitrypsin Deficiency Launch will be responsible for supporting unbranded and branded efforts for INBRX-101, which is expected to be the first innovative medicine in the AATD space in several years. The role will work closely with the US and global brand teams, as well as with the US Go-to-Market Capabilities (GTMC) team to create and drive clear and data-driven action plans. The successful candidate will support the market development strategy-leveraging digital tools and analytics-and promotional strategy-ensuring the pull-through of strategic differentiators into patient, account, and health systems channels. This position will report to the Alpha-1 Antitrypsin Deficiency US Launch Lead, and will be based in Cambridge, MA. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Main Responsibilities Support the development and execution of the US commercial strategy for the INBRX-101 launch Create and drive clear and data-driven market development and promotional action plans Collaborate extensively with marketing, GTMC, and other functions to ensure we achieve key milestones and targets Manage external vendor relationships and budgets to ensure effective execution of strategy and tactical plan About You Bachelor degree required, MBA a plus Minimum of 5+ years of progressive experience marketing in pharmaceutical/biotech commercial teams with a minimum of 2 years of experience marketing and launching drugs in the U.S. required Specialty therapeutic and immunology experience strongly preferred Ability to leverage insights and analytics in the development of clear and data-driven action plans; a thinker who is both big picture as well as detail-oriented with a strong sense of urgency Demonstrated ability to autonomously lead, prioritize, and manage multiple projects from start to finish, and effectively collaborate and engage with internal and external partners Knowledge of the Legal and Regulatory landscape pertaining to pharmaceutical marketing; including Medical/Legal/Regulatory Review Committee process 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 a 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job Title: Associate Director, Market Access Training Location: Cambridge, MA Morristown, NJ About the Job Sanofi has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases, multiple sclerosis, immunology and oncology, we are dedicated to making a positive impact on the lives of the patients and families we serve. Sanofi's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. Sanofi's reach and resources makes us one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. At Sanofi, we chase the miracles of science to improve people's lives. Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and specialty care. The Sanofi Associate Director Market Access Training, reports to the Head of Strategy and Operations for US Market Access and is based in Cambridge, MA or Morristown, NJ. The Lead, US Market Access Training is responsible for developing and implementing comprehensive training programs that enable the Market Access team to effectively engage with payers, integrated delivery networks, and other healthcare stakeholders. This role will drive the strategic direction of Market Access training initiatives, ensuring all team members possess the knowledge, skills, and tools necessary to successfully navigate the complex US healthcare landscape and deliver exceptional value to both internal and external customers. This includes responsibility for implementation, measurement, and continuous improvement to the following work streams: We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Main Responsibilities: Training Strategy & Development: Develop and execute an annual training plan aligned with business objectives and market access strategies Design, implement, and evaluate market access training programs, including new hire onboarding, ongoing skill development, and advanced market access concepts Create innovative learning solutions that address identified knowledge gaps and enhance team capabilities Establish metrics to measure training effectiveness and impact on business outcomes Cross-Functional Collaboration Partner closely with Access Strategy and Account Teams to identify training needs and develop targeted solutions Work with compliance to ensure all training materials and programs adhere to industry regulations and company policies Engage with external vendors and subject matter experts to supplement internal training resources Collaborate with GTMC (Go To Market Capabilities) learning and development teams to bring Sanofi development programs to US Market Access Content Development & Delivery Develop comprehensive training materials including presentations, e-learning modules, job aids, Echo flash cards and reference guides Facilitate live training sessions, workshops, and role-playing exercises Implement blended learning approaches to accommodate different learning styles and operational constraints Maintain and update training content to reflect new launches and company strategies Ensure training content is updated and compliant Lead the measurement and feedback of all training programs Develop and maintain new hire training programs and curriculum Lead the coordination and assist in the facilitation of all Market Access Role New Hire training About You Basic Qualifications: BA/BS Degree required, preferably in life science or business. MBA a plus. The ideal candidate will have 5 plus years of relevant pharmaceutical/biotech industry experience Proven communication skills with a well-developed ability to efficiently and productively communicate both verbally and in writing Highly organized, with strong project management skills Demonstrate excellence in building workshops for brand/product and advanced sales skills Ability to influence, collaborate and interact effectively a senior leadership team and multiple key stakeholders across sales and marketing to align objectives and provide consistent training direction Demonstrated excellence in project management and effectively managing multiple projects/priorities including budgeting and actual spend against budget is required Ensure that all training programs are consistent with, and supporting of, company legal, regulatory and compliance guidelines 25-35% national travel required Preferred Qualifications Market Access Experience Training or Learning Design experience Excellent verbal & written communication skills essential to success in this position Strong collaboration, organizational and operations skills Ideal candidate will have experience in specialty pharmaceuticals or biologics market access, with a background in infusible products, specialty pharmacy, and buy & bill, and product launch 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
10/20/2025
Full time
Job Title: Associate Director, Market Access Training Location: Cambridge, MA Morristown, NJ About the Job Sanofi has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases, multiple sclerosis, immunology and oncology, we are dedicated to making a positive impact on the lives of the patients and families we serve. Sanofi's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. Sanofi's reach and resources makes us one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. At Sanofi, we chase the miracles of science to improve people's lives. Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and specialty care. The Sanofi Associate Director Market Access Training, reports to the Head of Strategy and Operations for US Market Access and is based in Cambridge, MA or Morristown, NJ. The Lead, US Market Access Training is responsible for developing and implementing comprehensive training programs that enable the Market Access team to effectively engage with payers, integrated delivery networks, and other healthcare stakeholders. This role will drive the strategic direction of Market Access training initiatives, ensuring all team members possess the knowledge, skills, and tools necessary to successfully navigate the complex US healthcare landscape and deliver exceptional value to both internal and external customers. This includes responsibility for implementation, measurement, and continuous improvement to the following work streams: We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Main Responsibilities: Training Strategy & Development: Develop and execute an annual training plan aligned with business objectives and market access strategies Design, implement, and evaluate market access training programs, including new hire onboarding, ongoing skill development, and advanced market access concepts Create innovative learning solutions that address identified knowledge gaps and enhance team capabilities Establish metrics to measure training effectiveness and impact on business outcomes Cross-Functional Collaboration Partner closely with Access Strategy and Account Teams to identify training needs and develop targeted solutions Work with compliance to ensure all training materials and programs adhere to industry regulations and company policies Engage with external vendors and subject matter experts to supplement internal training resources Collaborate with GTMC (Go To Market Capabilities) learning and development teams to bring Sanofi development programs to US Market Access Content Development & Delivery Develop comprehensive training materials including presentations, e-learning modules, job aids, Echo flash cards and reference guides Facilitate live training sessions, workshops, and role-playing exercises Implement blended learning approaches to accommodate different learning styles and operational constraints Maintain and update training content to reflect new launches and company strategies Ensure training content is updated and compliant Lead the measurement and feedback of all training programs Develop and maintain new hire training programs and curriculum Lead the coordination and assist in the facilitation of all Market Access Role New Hire training About You Basic Qualifications: BA/BS Degree required, preferably in life science or business. MBA a plus. The ideal candidate will have 5 plus years of relevant pharmaceutical/biotech industry experience Proven communication skills with a well-developed ability to efficiently and productively communicate both verbally and in writing Highly organized, with strong project management skills Demonstrate excellence in building workshops for brand/product and advanced sales skills Ability to influence, collaborate and interact effectively a senior leadership team and multiple key stakeholders across sales and marketing to align objectives and provide consistent training direction Demonstrated excellence in project management and effectively managing multiple projects/priorities including budgeting and actual spend against budget is required Ensure that all training programs are consistent with, and supporting of, company legal, regulatory and compliance guidelines 25-35% national travel required Preferred Qualifications Market Access Experience Training or Learning Design experience Excellent verbal & written communication skills essential to success in this position Strong collaboration, organizational and operations skills Ideal candidate will have experience in specialty pharmaceuticals or biologics market access, with a background in infusible products, specialty pharmacy, and buy & bill, and product launch 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job Title: Director, Global Regulatory Affairs - Global Labeling Strategy Location: Morristown, NJ Cambridge, MA 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. The Director, Global Regulatory Affairs - Global Labeling Strategy is responsible for leading the development and implementation of global labeling strategy for assigned products, including those in early and late-stage development, life cycle management (LCM), and marketed portfolios. This role provides functional leadership and oversight for one or more therapeutic areas and may supervise or mentor Global Labeling Strategists. The Director plays an active role in shaping labeling strategy early in product development by providing regulatory input into clinical development plans, including guidance on Phase 2 and Phase 3 protocols, recommendation for the selection of endpoints relevant for labeling, and consideration of patient experience data (e.g., Patient Report Outcomes, quality of life measures). This strategic input ensures alignment between clinical evidence generation and future labeling opportunities aligned with the Sanofi "Label as a driver" philosophy. The Director ensures that core labeling (e.g., Company Core Data Sheets) and regional labeling (e.g., US Prescribing Information, EU SmPC) comply with global regulatory requirements, reflect current scientific and clinical evidence, and support the safe and effective use of Sanofi products. The role is accountable for the quality and consistency of labeling content across global markets and supports interactions with regulatory authorities during labeling development and negotiation. 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: Lead the development, maintenance, and alignment of global labeling strategy and content (e.g., CCDS, USPI, SmPC) for assigned products throughout the product lifecycle. Provide regulatory labeling leadership to cross-functional teams (Regulatory Strategy, Clinical Development, Medical Affairs, Pharmacovigilance, Market Access ). Contribute to early development programs by identifying labeling-relevant clinical endpoints, offering strategic input into the design of Phase 2 and Phase 3 clinical trials. Assess opportunities for the integration of patient experience data (e.g., PROs, QoL measures) to support future labeling claims. Represent Global Labeling on global regulatory teams and labeling sub-teams; lead labeling-related discussions and decision-making. Coordinate end-to-end labeling processes, including governance review, internal alignment, and submission planning for regulatory dossiers. Support regulatory agency interactions and negotiations involving labeling content; contribute to strategy for responding to health authority questions or label revisions. Ensure consistency between core and local market labeling; collaborate with regional /country regulatory teams to address labeling implementation or compliance issues. Monitor external regulatory environment, competitor labeling trends, and emerging guidance to inform strategic labeling decisions, and partner with GRA policy teams to connect the evolution in the environment with the labelling strategy May lead or participate in process improvement, digital transformation, or operational excellence initiatives within Global Labeling and transversally across GRA/Sanofi as applicable. Mentor and guide junior team members; may directly supervise Global Labeling Strategists depending on organizational structure. About You Earned Bachelor's degree in life sciences, pharmacy, or medically related field required. Advanced degree (PharmD, PhD, MD or MSc) preferred. Minimum 10 years of experience in the pharmaceutical or biotechnology industry, including 5+ years in regulatory affairs with significant experience in labeling strategy. Experience with investigational and marketed products across multiple regions (US, EU required). Proven involvement in early development labeling strategy, including contributions to clinical protocol development and endpoint discussions. Experience incorporating patient-focused evidence into labeling strategy is a plus. Prior experience managing or mentoring team members is preferred. Strong knowledge of global regulatory labeling requirements (FDA, EMA, ICH) and lifecycle labeling best practices. Strategic thinking with the ability to anticipate and influence regulatory direction across the development continuum. Scientific rigor and analytical ability to interpret complex data and develop regulatory-sound labeling content. Proven leadership and collaboration skills in cross-functional, matrixed environments. Excellent communication, negotiation, and stakeholder management skills. Project and time management expertise; able to manage multiple priorities in parallel. Strong understanding of regulatory submission processes and health authority interactions. 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. Exposure to cutting-edge technologies and research methodologies. Networking opportunities within Sanofi and the broader biotech community. 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
10/20/2025
Full time
Job Title: Director, Global Regulatory Affairs - Global Labeling Strategy Location: Morristown, NJ Cambridge, MA 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. The Director, Global Regulatory Affairs - Global Labeling Strategy is responsible for leading the development and implementation of global labeling strategy for assigned products, including those in early and late-stage development, life cycle management (LCM), and marketed portfolios. This role provides functional leadership and oversight for one or more therapeutic areas and may supervise or mentor Global Labeling Strategists. The Director plays an active role in shaping labeling strategy early in product development by providing regulatory input into clinical development plans, including guidance on Phase 2 and Phase 3 protocols, recommendation for the selection of endpoints relevant for labeling, and consideration of patient experience data (e.g., Patient Report Outcomes, quality of life measures). This strategic input ensures alignment between clinical evidence generation and future labeling opportunities aligned with the Sanofi "Label as a driver" philosophy. The Director ensures that core labeling (e.g., Company Core Data Sheets) and regional labeling (e.g., US Prescribing Information, EU SmPC) comply with global regulatory requirements, reflect current scientific and clinical evidence, and support the safe and effective use of Sanofi products. The role is accountable for the quality and consistency of labeling content across global markets and supports interactions with regulatory authorities during labeling development and negotiation. 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: Lead the development, maintenance, and alignment of global labeling strategy and content (e.g., CCDS, USPI, SmPC) for assigned products throughout the product lifecycle. Provide regulatory labeling leadership to cross-functional teams (Regulatory Strategy, Clinical Development, Medical Affairs, Pharmacovigilance, Market Access ). Contribute to early development programs by identifying labeling-relevant clinical endpoints, offering strategic input into the design of Phase 2 and Phase 3 clinical trials. Assess opportunities for the integration of patient experience data (e.g., PROs, QoL measures) to support future labeling claims. Represent Global Labeling on global regulatory teams and labeling sub-teams; lead labeling-related discussions and decision-making. Coordinate end-to-end labeling processes, including governance review, internal alignment, and submission planning for regulatory dossiers. Support regulatory agency interactions and negotiations involving labeling content; contribute to strategy for responding to health authority questions or label revisions. Ensure consistency between core and local market labeling; collaborate with regional /country regulatory teams to address labeling implementation or compliance issues. Monitor external regulatory environment, competitor labeling trends, and emerging guidance to inform strategic labeling decisions, and partner with GRA policy teams to connect the evolution in the environment with the labelling strategy May lead or participate in process improvement, digital transformation, or operational excellence initiatives within Global Labeling and transversally across GRA/Sanofi as applicable. Mentor and guide junior team members; may directly supervise Global Labeling Strategists depending on organizational structure. About You Earned Bachelor's degree in life sciences, pharmacy, or medically related field required. Advanced degree (PharmD, PhD, MD or MSc) preferred. Minimum 10 years of experience in the pharmaceutical or biotechnology industry, including 5+ years in regulatory affairs with significant experience in labeling strategy. Experience with investigational and marketed products across multiple regions (US, EU required). Proven involvement in early development labeling strategy, including contributions to clinical protocol development and endpoint discussions. Experience incorporating patient-focused evidence into labeling strategy is a plus. Prior experience managing or mentoring team members is preferred. Strong knowledge of global regulatory labeling requirements (FDA, EMA, ICH) and lifecycle labeling best practices. Strategic thinking with the ability to anticipate and influence regulatory direction across the development continuum. Scientific rigor and analytical ability to interpret complex data and develop regulatory-sound labeling content. Proven leadership and collaboration skills in cross-functional, matrixed environments. Excellent communication, negotiation, and stakeholder management skills. Project and time management expertise; able to manage multiple priorities in parallel. Strong understanding of regulatory submission processes and health authority interactions. 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. Exposure to cutting-edge technologies and research methodologies. Networking opportunities within Sanofi and the broader biotech community. 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job Title: Director, Marketing Strategic Accounts T1D Location: Cambridge, MA Morristown, NJ About the Job The Director of Marketing Strategic Accounts T1D serves as a key member of the brand marketing team reporting to the Sr. Director of Site of Care Marketing. This role bridges brand strategy and field execution, translating brand imperatives into actionable tools, resources, and engagement models that empower the newly formed Strategic Account Manager (SAM) team to drive institutional partnerships, pathway development, access expansion and site activation in support of brand adoption. The Director of Marketing Strategic Accounts T1D partners closely with the Early Detection T1D Marketer to ensure a cohesive and coordinated approach to account development - spanning awareness, early detection, and site activation. The role requires a deep understanding of integrated delivery networks, healthcare ecosystems, and the levers that influence institutional decision-making. We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue progress to make a real impact on millions of patients around the world. Main Responsibilities Develop and execute the strategic account marketing plan to empower the newly formed Strategic Account Management (SAM) team in driving institutional collaboration, pathway development, and site activation in alignment with TZIELD's brand and access objectives Leverage a deep understanding of the patient journey at the site-of-care level to identify key decision-maker needs, barriers, and opportunities among C/D suite leaders, P&T committee sponsors, and departmental stakeholders Collaborate cross-functionally with HCP, Consumer, Access, and Early Detection Marketing teams to ensure a cohesive strategy, consistent messaging, and unified calls to action across all customer touchpoints Partner with account leadership to assess and deliver the appropriate mix of branded and unbranded resources that enhance SAM engagement, improve account understanding, and accelerate institutional adoption Integrate field insights and regional learnings into brand planning and resource development to continuously refine institutional marketing strategy and execution Coordinate with GTMC and Training to ensure marketing initiatives and materials are effectively incorporated into SAM onboarding and capability-building programs Partner cross functionally to design and adapt population-health resources that enable value-based discussions with health system stakeholders. Lead the development, review, and approval of marketing materials in collaboration with Regulatory, Legal, and Compliance to ensure adherence to all company policies, SOPs, and applicable guidelines Support marketing budget and resources efficiently, providing regular updates on performance Travel within commercial regions to support meetings, events, and field engagements (estimated 10-20%) About You Qualifications Bachelor's degree required; advanced degree (MBA, PharmD, etc.) preferred 10+ years of pharmaceutical or biopharmaceutical industry experience in marketing, sales or related roles with 3+ years of marketing experience preferred Ability to analyze complex market data and translate insights into actionable strategies Strong clinical knowledge and understanding of relevant therapeutic areas Experience working within a cross-functional, matrixed environment with the ability to influence, mobilize and manage a complex set of internal stakeholders and processes. Excellent communication, organizational, and project management, budget management & presentation skills Experience with MLR (Medical, Legal, Regulatory) review process a plus 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
10/20/2025
Full time
Job Title: Director, Marketing Strategic Accounts T1D Location: Cambridge, MA Morristown, NJ About the Job The Director of Marketing Strategic Accounts T1D serves as a key member of the brand marketing team reporting to the Sr. Director of Site of Care Marketing. This role bridges brand strategy and field execution, translating brand imperatives into actionable tools, resources, and engagement models that empower the newly formed Strategic Account Manager (SAM) team to drive institutional partnerships, pathway development, access expansion and site activation in support of brand adoption. The Director of Marketing Strategic Accounts T1D partners closely with the Early Detection T1D Marketer to ensure a cohesive and coordinated approach to account development - spanning awareness, early detection, and site activation. The role requires a deep understanding of integrated delivery networks, healthcare ecosystems, and the levers that influence institutional decision-making. We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue progress to make a real impact on millions of patients around the world. Main Responsibilities Develop and execute the strategic account marketing plan to empower the newly formed Strategic Account Management (SAM) team in driving institutional collaboration, pathway development, and site activation in alignment with TZIELD's brand and access objectives Leverage a deep understanding of the patient journey at the site-of-care level to identify key decision-maker needs, barriers, and opportunities among C/D suite leaders, P&T committee sponsors, and departmental stakeholders Collaborate cross-functionally with HCP, Consumer, Access, and Early Detection Marketing teams to ensure a cohesive strategy, consistent messaging, and unified calls to action across all customer touchpoints Partner with account leadership to assess and deliver the appropriate mix of branded and unbranded resources that enhance SAM engagement, improve account understanding, and accelerate institutional adoption Integrate field insights and regional learnings into brand planning and resource development to continuously refine institutional marketing strategy and execution Coordinate with GTMC and Training to ensure marketing initiatives and materials are effectively incorporated into SAM onboarding and capability-building programs Partner cross functionally to design and adapt population-health resources that enable value-based discussions with health system stakeholders. Lead the development, review, and approval of marketing materials in collaboration with Regulatory, Legal, and Compliance to ensure adherence to all company policies, SOPs, and applicable guidelines Support marketing budget and resources efficiently, providing regular updates on performance Travel within commercial regions to support meetings, events, and field engagements (estimated 10-20%) About You Qualifications Bachelor's degree required; advanced degree (MBA, PharmD, etc.) preferred 10+ years of pharmaceutical or biopharmaceutical industry experience in marketing, sales or related roles with 3+ years of marketing experience preferred Ability to analyze complex market data and translate insights into actionable strategies Strong clinical knowledge and understanding of relevant therapeutic areas Experience working within a cross-functional, matrixed environment with the ability to influence, mobilize and manage a complex set of internal stakeholders and processes. Excellent communication, organizational, and project management, budget management & presentation skills Experience with MLR (Medical, Legal, Regulatory) review process a plus 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job Title: Associate Director, Marketing - Early Detection T1D Location: Remote/Field About the Job The Associate Director, Marketing - Early Detection (T1D) plays a critical role in shaping the ecosystem for Type 1 Diabetes (T1D) early detection and intervention. As a key member of the U.S. TZIELD marketing team, this role bridges local market needs with national brand strategy to accelerate the identification and engagement of at-risk patients through care pathway initiatives. This individual serves as the strategic marketing lead supporting the Care Pathway Educator (CPE) team - a newly formed, field-based organization dedicated to improving care coordination and education across endocrinology, primary care, and health system settings. The Associate Director will translate brand vision into scalable field enablement resources and programs designed to drive earlier diagnosis, care standardization, and readiness for brand adoption when appropriate. This position partners closely with the Strategic Account Marketer to ensure alignment with strategically important account development. It also works cross-functionally with Sales, Medical, Training, Payer Access & Public Affairs (PA&PA), Patient Support Services (PSS), and the broader marketing organization to maintain strong alignment with the overall key account strategy. We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue progress to make a real impact on millions of patients around the world. Main Responsibilities Serve as the marketing lead for early detection initiatives, aligning unbranded ecosystem efforts with long-term brand objectives and the patient journey strategy Partner with the Sr. Director, Site of Care Marketing, to evolve the early detection strategy as a critical lever for TZIELD market development and access expansion Shape the positioning, narrative, and value proposition of the Care Pathway Educator (CPE) team to ensure consistent, compliant, and compelling external engagement Translate insights from field teams and health systems into actionable marketing strategies that remove barriers to early testing and diagnosis Identify and activate opportunities within key accounts to build screening pathways, referral networks, and multidisciplinary engagement models Provide strategic and tactical support to the CPE team, including the development of unbranded materials, pathway tools, and educational resources Partner closely with the Strategic Account Marketing and Field Account Teams (SAM/CPE) to ensure early detection priorities are integrated into key account strategies Collaborate across marketing, medical, training, payer access & public affairs, patient support services, and analytics to ensure seamless execution and measurable impact Develop metrics, dashboards, and feedback loops to track field engagement effectiveness and inform future resource development Ensure unbranded initiatives remain credible, compliant, and grounded in scientific integrity while advancing ecosystem readiness for TZIELD Travel within regions to support meetings, events, and field engagements (estimated 10-20%) About You Qualifications Bachelor's degree required; advanced degree (MBA, PharmD, etc.) preferred 8+ years of pharmaceutical or biopharmaceutical industry experience in marketing, sales or related roles with 3+ years of marketing experience preferred Ability to analyze complex market data and translate insights into actionable strategies Strong clinical knowledge and understanding of relevant therapeutic areas Experience working within a cross-functional, matrixed environment with the ability to influence, mobilize and manage a complex set of internal stakeholders and processes. Excellent communication, organizational, and project management, budget management & presentation skills Experience with MLR (Medical, Legal, Regulatory) review process a plus Willingness and ability to travel within Commercial regions 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
10/20/2025
Full time
Job Title: Associate Director, Marketing - Early Detection T1D Location: Remote/Field About the Job The Associate Director, Marketing - Early Detection (T1D) plays a critical role in shaping the ecosystem for Type 1 Diabetes (T1D) early detection and intervention. As a key member of the U.S. TZIELD marketing team, this role bridges local market needs with national brand strategy to accelerate the identification and engagement of at-risk patients through care pathway initiatives. This individual serves as the strategic marketing lead supporting the Care Pathway Educator (CPE) team - a newly formed, field-based organization dedicated to improving care coordination and education across endocrinology, primary care, and health system settings. The Associate Director will translate brand vision into scalable field enablement resources and programs designed to drive earlier diagnosis, care standardization, and readiness for brand adoption when appropriate. This position partners closely with the Strategic Account Marketer to ensure alignment with strategically important account development. It also works cross-functionally with Sales, Medical, Training, Payer Access & Public Affairs (PA&PA), Patient Support Services (PSS), and the broader marketing organization to maintain strong alignment with the overall key account strategy. We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue progress to make a real impact on millions of patients around the world. Main Responsibilities Serve as the marketing lead for early detection initiatives, aligning unbranded ecosystem efforts with long-term brand objectives and the patient journey strategy Partner with the Sr. Director, Site of Care Marketing, to evolve the early detection strategy as a critical lever for TZIELD market development and access expansion Shape the positioning, narrative, and value proposition of the Care Pathway Educator (CPE) team to ensure consistent, compliant, and compelling external engagement Translate insights from field teams and health systems into actionable marketing strategies that remove barriers to early testing and diagnosis Identify and activate opportunities within key accounts to build screening pathways, referral networks, and multidisciplinary engagement models Provide strategic and tactical support to the CPE team, including the development of unbranded materials, pathway tools, and educational resources Partner closely with the Strategic Account Marketing and Field Account Teams (SAM/CPE) to ensure early detection priorities are integrated into key account strategies Collaborate across marketing, medical, training, payer access & public affairs, patient support services, and analytics to ensure seamless execution and measurable impact Develop metrics, dashboards, and feedback loops to track field engagement effectiveness and inform future resource development Ensure unbranded initiatives remain credible, compliant, and grounded in scientific integrity while advancing ecosystem readiness for TZIELD Travel within regions to support meetings, events, and field engagements (estimated 10-20%) About You Qualifications Bachelor's degree required; advanced degree (MBA, PharmD, etc.) preferred 8+ years of pharmaceutical or biopharmaceutical industry experience in marketing, sales or related roles with 3+ years of marketing experience preferred Ability to analyze complex market data and translate insights into actionable strategies Strong clinical knowledge and understanding of relevant therapeutic areas Experience working within a cross-functional, matrixed environment with the ability to influence, mobilize and manage a complex set of internal stakeholders and processes. Excellent communication, organizational, and project management, budget management & presentation skills Experience with MLR (Medical, Legal, Regulatory) review process a plus Willingness and ability to travel within Commercial regions 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Seeking a BC/BE Internal Medicine or Family Medicine Physician who is intrinsically motivated to provide excellent care to older adults in Birmingham, AL. Position Highlights: Full-Time, Monday through Friday, 8:00 AM - 5:00 PM Fellowship training in Geriatrics preferred Highly qualified candidates may also be considered for a Center Medical Director position. Deliver higher quality health and wellness care that improves outcomes, manages medical costs and provides an unmatched experience for adults on Medicare in medically underserved communities. Innumerable support resources to help you provide outstanding care. Benefits: Competitive Salary Quarterly bonus based on quality metrics 6 weeks of PTO, inclusive of PTO, major holidays, and CME Continuing Medical Education stipend Tuition Reimbursement Provided Health, Vision, Dental, and Life Insurance 401K Investment, up to 4% company match, vested immediately Provided Medical Malpractice Insurance Partnership Track Dedicated Medical Scribe and Medical Assistant Relocation package on a case-by-case basis Opportunities for leadership development New centers and flexible work environments Opportunities for high levels of responsibility and rapid advancement The Community: Birmingham, Alabama, is a city rich in history and cultural significance, particularly in the realms of the civil rights movement and industrial development. Founded in 1871, it quickly grew into the South s industrial hub, particularly due to its abundant natural resources like coal, iron ore, and limestone. This combination earned it the nickname "The Pittsburgh of the South." During the 20th century, Birmingham was a key player in the steel industry, though the city has since diversified into sectors like finance, healthcare, and technology. Its historical importance is also tied to the civil rights movement, with pivotal events such as the 1963 Birmingham campaign, led by figures like Martin Luther King Jr., highlighting the city's role in the fight for racial equality. Today, Birmingham is a vibrant city with a burgeoning cultural scene and a growing economy. Its downtown area has seen significant revitalization in recent years, with new restaurants, craft breweries, and art galleries adding to the city's appeal. The city is home to several important institutions, including the University of Alabama at Birmingham (UAB), which is a major medical and research center. Birmingham is also known for its beautiful parks, such as Railroad Park, and landmarks like Vulcan Park, which houses the world s largest cast-iron statue. While it continues to confront challenges related to its past, Birmingham is often recognized for its resilience and ongoing efforts to reinvent itself as a modern, dynamic Southern city. APPLY NOW or TEXT Job and email address to 636 - 628 - 2412. Search all of our provider opportunities at: brittmedical DOT com
10/20/2025
Full time
Seeking a BC/BE Internal Medicine or Family Medicine Physician who is intrinsically motivated to provide excellent care to older adults in Birmingham, AL. Position Highlights: Full-Time, Monday through Friday, 8:00 AM - 5:00 PM Fellowship training in Geriatrics preferred Highly qualified candidates may also be considered for a Center Medical Director position. Deliver higher quality health and wellness care that improves outcomes, manages medical costs and provides an unmatched experience for adults on Medicare in medically underserved communities. Innumerable support resources to help you provide outstanding care. Benefits: Competitive Salary Quarterly bonus based on quality metrics 6 weeks of PTO, inclusive of PTO, major holidays, and CME Continuing Medical Education stipend Tuition Reimbursement Provided Health, Vision, Dental, and Life Insurance 401K Investment, up to 4% company match, vested immediately Provided Medical Malpractice Insurance Partnership Track Dedicated Medical Scribe and Medical Assistant Relocation package on a case-by-case basis Opportunities for leadership development New centers and flexible work environments Opportunities for high levels of responsibility and rapid advancement The Community: Birmingham, Alabama, is a city rich in history and cultural significance, particularly in the realms of the civil rights movement and industrial development. Founded in 1871, it quickly grew into the South s industrial hub, particularly due to its abundant natural resources like coal, iron ore, and limestone. This combination earned it the nickname "The Pittsburgh of the South." During the 20th century, Birmingham was a key player in the steel industry, though the city has since diversified into sectors like finance, healthcare, and technology. Its historical importance is also tied to the civil rights movement, with pivotal events such as the 1963 Birmingham campaign, led by figures like Martin Luther King Jr., highlighting the city's role in the fight for racial equality. Today, Birmingham is a vibrant city with a burgeoning cultural scene and a growing economy. Its downtown area has seen significant revitalization in recent years, with new restaurants, craft breweries, and art galleries adding to the city's appeal. The city is home to several important institutions, including the University of Alabama at Birmingham (UAB), which is a major medical and research center. Birmingham is also known for its beautiful parks, such as Railroad Park, and landmarks like Vulcan Park, which houses the world s largest cast-iron statue. While it continues to confront challenges related to its past, Birmingham is often recognized for its resilience and ongoing efforts to reinvent itself as a modern, dynamic Southern city. APPLY NOW or TEXT Job and email address to 636 - 628 - 2412. Search all of our provider opportunities at: brittmedical DOT com
Job Title: Associate Director, Marketing - Early Detection T1D Location: Remote/Field About the Job The Associate Director, Marketing - Early Detection (T1D) plays a critical role in shaping the ecosystem for Type 1 Diabetes (T1D) early detection and intervention. As a key member of the U.S. TZIELD marketing team, this role bridges local market needs with national brand strategy to accelerate the identification and engagement of at-risk patients through care pathway initiatives. This individual serves as the strategic marketing lead supporting the Care Pathway Educator (CPE) team - a newly formed, field-based organization dedicated to improving care coordination and education across endocrinology, primary care, and health system settings. The Associate Director will translate brand vision into scalable field enablement resources and programs designed to drive earlier diagnosis, care standardization, and readiness for brand adoption when appropriate. This position partners closely with the Strategic Account Marketer to ensure alignment with strategically important account development. It also works cross-functionally with Sales, Medical, Training, Payer Access & Public Affairs (PA&PA), Patient Support Services (PSS), and the broader marketing organization to maintain strong alignment with the overall key account strategy. We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue progress to make a real impact on millions of patients around the world. Main Responsibilities Serve as the marketing lead for early detection initiatives, aligning unbranded ecosystem efforts with long-term brand objectives and the patient journey strategy Partner with the Sr. Director, Site of Care Marketing, to evolve the early detection strategy as a critical lever for TZIELD market development and access expansion Shape the positioning, narrative, and value proposition of the Care Pathway Educator (CPE) team to ensure consistent, compliant, and compelling external engagement Translate insights from field teams and health systems into actionable marketing strategies that remove barriers to early testing and diagnosis Identify and activate opportunities within key accounts to build screening pathways, referral networks, and multidisciplinary engagement models Provide strategic and tactical support to the CPE team, including the development of unbranded materials, pathway tools, and educational resources Partner closely with the Strategic Account Marketing and Field Account Teams (SAM/CPE) to ensure early detection priorities are integrated into key account strategies Collaborate across marketing, medical, training, payer access & public affairs, patient support services, and analytics to ensure seamless execution and measurable impact Develop metrics, dashboards, and feedback loops to track field engagement effectiveness and inform future resource development Ensure unbranded initiatives remain credible, compliant, and grounded in scientific integrity while advancing ecosystem readiness for TZIELD Travel within regions to support meetings, events, and field engagements (estimated 10-20%) About You Qualifications Bachelor's degree required; advanced degree (MBA, PharmD, etc.) preferred 8+ years of pharmaceutical or biopharmaceutical industry experience in marketing, sales or related roles with 3+ years of marketing experience preferred Ability to analyze complex market data and translate insights into actionable strategies Strong clinical knowledge and understanding of relevant therapeutic areas Experience working within a cross-functional, matrixed environment with the ability to influence, mobilize and manage a complex set of internal stakeholders and processes. Excellent communication, organizational, and project management, budget management & presentation skills Experience with MLR (Medical, Legal, Regulatory) review process a plus Willingness and ability to travel within Commercial regions 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
10/20/2025
Full time
Job Title: Associate Director, Marketing - Early Detection T1D Location: Remote/Field About the Job The Associate Director, Marketing - Early Detection (T1D) plays a critical role in shaping the ecosystem for Type 1 Diabetes (T1D) early detection and intervention. As a key member of the U.S. TZIELD marketing team, this role bridges local market needs with national brand strategy to accelerate the identification and engagement of at-risk patients through care pathway initiatives. This individual serves as the strategic marketing lead supporting the Care Pathway Educator (CPE) team - a newly formed, field-based organization dedicated to improving care coordination and education across endocrinology, primary care, and health system settings. The Associate Director will translate brand vision into scalable field enablement resources and programs designed to drive earlier diagnosis, care standardization, and readiness for brand adoption when appropriate. This position partners closely with the Strategic Account Marketer to ensure alignment with strategically important account development. It also works cross-functionally with Sales, Medical, Training, Payer Access & Public Affairs (PA&PA), Patient Support Services (PSS), and the broader marketing organization to maintain strong alignment with the overall key account strategy. We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue progress to make a real impact on millions of patients around the world. Main Responsibilities Serve as the marketing lead for early detection initiatives, aligning unbranded ecosystem efforts with long-term brand objectives and the patient journey strategy Partner with the Sr. Director, Site of Care Marketing, to evolve the early detection strategy as a critical lever for TZIELD market development and access expansion Shape the positioning, narrative, and value proposition of the Care Pathway Educator (CPE) team to ensure consistent, compliant, and compelling external engagement Translate insights from field teams and health systems into actionable marketing strategies that remove barriers to early testing and diagnosis Identify and activate opportunities within key accounts to build screening pathways, referral networks, and multidisciplinary engagement models Provide strategic and tactical support to the CPE team, including the development of unbranded materials, pathway tools, and educational resources Partner closely with the Strategic Account Marketing and Field Account Teams (SAM/CPE) to ensure early detection priorities are integrated into key account strategies Collaborate across marketing, medical, training, payer access & public affairs, patient support services, and analytics to ensure seamless execution and measurable impact Develop metrics, dashboards, and feedback loops to track field engagement effectiveness and inform future resource development Ensure unbranded initiatives remain credible, compliant, and grounded in scientific integrity while advancing ecosystem readiness for TZIELD Travel within regions to support meetings, events, and field engagements (estimated 10-20%) About You Qualifications Bachelor's degree required; advanced degree (MBA, PharmD, etc.) preferred 8+ years of pharmaceutical or biopharmaceutical industry experience in marketing, sales or related roles with 3+ years of marketing experience preferred Ability to analyze complex market data and translate insights into actionable strategies Strong clinical knowledge and understanding of relevant therapeutic areas Experience working within a cross-functional, matrixed environment with the ability to influence, mobilize and manage a complex set of internal stakeholders and processes. Excellent communication, organizational, and project management, budget management & presentation skills Experience with MLR (Medical, Legal, Regulatory) review process a plus Willingness and ability to travel within Commercial regions 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job Title: Director, Global Regulatory Affairs - Global Labeling Strategy Location: Morristown, NJ Cambridge, MA 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. The Director, Global Regulatory Affairs - Global Labeling Strategy is responsible for leading the development and implementation of global labeling strategy for assigned products, including those in early and late-stage development, life cycle management (LCM), and marketed portfolios. This role provides functional leadership and oversight for one or more therapeutic areas and may supervise or mentor Global Labeling Strategists. The Director plays an active role in shaping labeling strategy early in product development by providing regulatory input into clinical development plans, including guidance on Phase 2 and Phase 3 protocols, recommendation for the selection of endpoints relevant for labeling, and consideration of patient experience data (e.g., Patient Report Outcomes, quality of life measures). This strategic input ensures alignment between clinical evidence generation and future labeling opportunities aligned with the Sanofi "Label as a driver" philosophy. The Director ensures that core labeling (e.g., Company Core Data Sheets) and regional labeling (e.g., US Prescribing Information, EU SmPC) comply with global regulatory requirements, reflect current scientific and clinical evidence, and support the safe and effective use of Sanofi products. The role is accountable for the quality and consistency of labeling content across global markets and supports interactions with regulatory authorities during labeling development and negotiation. 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: Lead the development, maintenance, and alignment of global labeling strategy and content (e.g., CCDS, USPI, SmPC) for assigned products throughout the product lifecycle. Provide regulatory labeling leadership to cross-functional teams (Regulatory Strategy, Clinical Development, Medical Affairs, Pharmacovigilance, Market Access ). Contribute to early development programs by identifying labeling-relevant clinical endpoints, offering strategic input into the design of Phase 2 and Phase 3 clinical trials. Assess opportunities for the integration of patient experience data (e.g., PROs, QoL measures) to support future labeling claims. Represent Global Labeling on global regulatory teams and labeling sub-teams; lead labeling-related discussions and decision-making. Coordinate end-to-end labeling processes, including governance review, internal alignment, and submission planning for regulatory dossiers. Support regulatory agency interactions and negotiations involving labeling content; contribute to strategy for responding to health authority questions or label revisions. Ensure consistency between core and local market labeling; collaborate with regional /country regulatory teams to address labeling implementation or compliance issues. Monitor external regulatory environment, competitor labeling trends, and emerging guidance to inform strategic labeling decisions, and partner with GRA policy teams to connect the evolution in the environment with the labelling strategy May lead or participate in process improvement, digital transformation, or operational excellence initiatives within Global Labeling and transversally across GRA/Sanofi as applicable. Mentor and guide junior team members; may directly supervise Global Labeling Strategists depending on organizational structure. About You Earned Bachelor's degree in life sciences, pharmacy, or medically related field required. Advanced degree (PharmD, PhD, MD or MSc) preferred. Minimum 10 years of experience in the pharmaceutical or biotechnology industry, including 5+ years in regulatory affairs with significant experience in labeling strategy. Experience with investigational and marketed products across multiple regions (US, EU required). Proven involvement in early development labeling strategy, including contributions to clinical protocol development and endpoint discussions. Experience incorporating patient-focused evidence into labeling strategy is a plus. Prior experience managing or mentoring team members is preferred. Strong knowledge of global regulatory labeling requirements (FDA, EMA, ICH) and lifecycle labeling best practices. Strategic thinking with the ability to anticipate and influence regulatory direction across the development continuum. Scientific rigor and analytical ability to interpret complex data and develop regulatory-sound labeling content. Proven leadership and collaboration skills in cross-functional, matrixed environments. Excellent communication, negotiation, and stakeholder management skills. Project and time management expertise; able to manage multiple priorities in parallel. Strong understanding of regulatory submission processes and health authority interactions. 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. Exposure to cutting-edge technologies and research methodologies. Networking opportunities within Sanofi and the broader biotech community. 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
10/20/2025
Full time
Job Title: Director, Global Regulatory Affairs - Global Labeling Strategy Location: Morristown, NJ Cambridge, MA 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. The Director, Global Regulatory Affairs - Global Labeling Strategy is responsible for leading the development and implementation of global labeling strategy for assigned products, including those in early and late-stage development, life cycle management (LCM), and marketed portfolios. This role provides functional leadership and oversight for one or more therapeutic areas and may supervise or mentor Global Labeling Strategists. The Director plays an active role in shaping labeling strategy early in product development by providing regulatory input into clinical development plans, including guidance on Phase 2 and Phase 3 protocols, recommendation for the selection of endpoints relevant for labeling, and consideration of patient experience data (e.g., Patient Report Outcomes, quality of life measures). This strategic input ensures alignment between clinical evidence generation and future labeling opportunities aligned with the Sanofi "Label as a driver" philosophy. The Director ensures that core labeling (e.g., Company Core Data Sheets) and regional labeling (e.g., US Prescribing Information, EU SmPC) comply with global regulatory requirements, reflect current scientific and clinical evidence, and support the safe and effective use of Sanofi products. The role is accountable for the quality and consistency of labeling content across global markets and supports interactions with regulatory authorities during labeling development and negotiation. 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: Lead the development, maintenance, and alignment of global labeling strategy and content (e.g., CCDS, USPI, SmPC) for assigned products throughout the product lifecycle. Provide regulatory labeling leadership to cross-functional teams (Regulatory Strategy, Clinical Development, Medical Affairs, Pharmacovigilance, Market Access ). Contribute to early development programs by identifying labeling-relevant clinical endpoints, offering strategic input into the design of Phase 2 and Phase 3 clinical trials. Assess opportunities for the integration of patient experience data (e.g., PROs, QoL measures) to support future labeling claims. Represent Global Labeling on global regulatory teams and labeling sub-teams; lead labeling-related discussions and decision-making. Coordinate end-to-end labeling processes, including governance review, internal alignment, and submission planning for regulatory dossiers. Support regulatory agency interactions and negotiations involving labeling content; contribute to strategy for responding to health authority questions or label revisions. Ensure consistency between core and local market labeling; collaborate with regional /country regulatory teams to address labeling implementation or compliance issues. Monitor external regulatory environment, competitor labeling trends, and emerging guidance to inform strategic labeling decisions, and partner with GRA policy teams to connect the evolution in the environment with the labelling strategy May lead or participate in process improvement, digital transformation, or operational excellence initiatives within Global Labeling and transversally across GRA/Sanofi as applicable. Mentor and guide junior team members; may directly supervise Global Labeling Strategists depending on organizational structure. About You Earned Bachelor's degree in life sciences, pharmacy, or medically related field required. Advanced degree (PharmD, PhD, MD or MSc) preferred. Minimum 10 years of experience in the pharmaceutical or biotechnology industry, including 5+ years in regulatory affairs with significant experience in labeling strategy. Experience with investigational and marketed products across multiple regions (US, EU required). Proven involvement in early development labeling strategy, including contributions to clinical protocol development and endpoint discussions. Experience incorporating patient-focused evidence into labeling strategy is a plus. Prior experience managing or mentoring team members is preferred. Strong knowledge of global regulatory labeling requirements (FDA, EMA, ICH) and lifecycle labeling best practices. Strategic thinking with the ability to anticipate and influence regulatory direction across the development continuum. Scientific rigor and analytical ability to interpret complex data and develop regulatory-sound labeling content. Proven leadership and collaboration skills in cross-functional, matrixed environments. Excellent communication, negotiation, and stakeholder management skills. Project and time management expertise; able to manage multiple priorities in parallel. Strong understanding of regulatory submission processes and health authority interactions. 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. Exposure to cutting-edge technologies and research methodologies. Networking opportunities within Sanofi and the broader biotech community. 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job Title: Director, Marketing Strategic Accounts T1D Location: Cambridge, MA Morristown, NJ About the Job The Director of Marketing Strategic Accounts T1D serves as a key member of the brand marketing team reporting to the Sr. Director of Site of Care Marketing. This role bridges brand strategy and field execution, translating brand imperatives into actionable tools, resources, and engagement models that empower the newly formed Strategic Account Manager (SAM) team to drive institutional partnerships, pathway development, access expansion and site activation in support of brand adoption. The Director of Marketing Strategic Accounts T1D partners closely with the Early Detection T1D Marketer to ensure a cohesive and coordinated approach to account development - spanning awareness, early detection, and site activation. The role requires a deep understanding of integrated delivery networks, healthcare ecosystems, and the levers that influence institutional decision-making. We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue progress to make a real impact on millions of patients around the world. Main Responsibilities Develop and execute the strategic account marketing plan to empower the newly formed Strategic Account Management (SAM) team in driving institutional collaboration, pathway development, and site activation in alignment with TZIELD's brand and access objectives Leverage a deep understanding of the patient journey at the site-of-care level to identify key decision-maker needs, barriers, and opportunities among C/D suite leaders, P&T committee sponsors, and departmental stakeholders Collaborate cross-functionally with HCP, Consumer, Access, and Early Detection Marketing teams to ensure a cohesive strategy, consistent messaging, and unified calls to action across all customer touchpoints Partner with account leadership to assess and deliver the appropriate mix of branded and unbranded resources that enhance SAM engagement, improve account understanding, and accelerate institutional adoption Integrate field insights and regional learnings into brand planning and resource development to continuously refine institutional marketing strategy and execution Coordinate with GTMC and Training to ensure marketing initiatives and materials are effectively incorporated into SAM onboarding and capability-building programs Partner cross functionally to design and adapt population-health resources that enable value-based discussions with health system stakeholders. Lead the development, review, and approval of marketing materials in collaboration with Regulatory, Legal, and Compliance to ensure adherence to all company policies, SOPs, and applicable guidelines Support marketing budget and resources efficiently, providing regular updates on performance Travel within commercial regions to support meetings, events, and field engagements (estimated 10-20%) About You Qualifications Bachelor's degree required; advanced degree (MBA, PharmD, etc.) preferred 10+ years of pharmaceutical or biopharmaceutical industry experience in marketing, sales or related roles with 3+ years of marketing experience preferred Ability to analyze complex market data and translate insights into actionable strategies Strong clinical knowledge and understanding of relevant therapeutic areas Experience working within a cross-functional, matrixed environment with the ability to influence, mobilize and manage a complex set of internal stakeholders and processes. Excellent communication, organizational, and project management, budget management & presentation skills Experience with MLR (Medical, Legal, Regulatory) review process a plus 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
10/20/2025
Full time
Job Title: Director, Marketing Strategic Accounts T1D Location: Cambridge, MA Morristown, NJ About the Job The Director of Marketing Strategic Accounts T1D serves as a key member of the brand marketing team reporting to the Sr. Director of Site of Care Marketing. This role bridges brand strategy and field execution, translating brand imperatives into actionable tools, resources, and engagement models that empower the newly formed Strategic Account Manager (SAM) team to drive institutional partnerships, pathway development, access expansion and site activation in support of brand adoption. The Director of Marketing Strategic Accounts T1D partners closely with the Early Detection T1D Marketer to ensure a cohesive and coordinated approach to account development - spanning awareness, early detection, and site activation. The role requires a deep understanding of integrated delivery networks, healthcare ecosystems, and the levers that influence institutional decision-making. We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue progress to make a real impact on millions of patients around the world. Main Responsibilities Develop and execute the strategic account marketing plan to empower the newly formed Strategic Account Management (SAM) team in driving institutional collaboration, pathway development, and site activation in alignment with TZIELD's brand and access objectives Leverage a deep understanding of the patient journey at the site-of-care level to identify key decision-maker needs, barriers, and opportunities among C/D suite leaders, P&T committee sponsors, and departmental stakeholders Collaborate cross-functionally with HCP, Consumer, Access, and Early Detection Marketing teams to ensure a cohesive strategy, consistent messaging, and unified calls to action across all customer touchpoints Partner with account leadership to assess and deliver the appropriate mix of branded and unbranded resources that enhance SAM engagement, improve account understanding, and accelerate institutional adoption Integrate field insights and regional learnings into brand planning and resource development to continuously refine institutional marketing strategy and execution Coordinate with GTMC and Training to ensure marketing initiatives and materials are effectively incorporated into SAM onboarding and capability-building programs Partner cross functionally to design and adapt population-health resources that enable value-based discussions with health system stakeholders. Lead the development, review, and approval of marketing materials in collaboration with Regulatory, Legal, and Compliance to ensure adherence to all company policies, SOPs, and applicable guidelines Support marketing budget and resources efficiently, providing regular updates on performance Travel within commercial regions to support meetings, events, and field engagements (estimated 10-20%) About You Qualifications Bachelor's degree required; advanced degree (MBA, PharmD, etc.) preferred 10+ years of pharmaceutical or biopharmaceutical industry experience in marketing, sales or related roles with 3+ years of marketing experience preferred Ability to analyze complex market data and translate insights into actionable strategies Strong clinical knowledge and understanding of relevant therapeutic areas Experience working within a cross-functional, matrixed environment with the ability to influence, mobilize and manage a complex set of internal stakeholders and processes. Excellent communication, organizational, and project management, budget management & presentation skills Experience with MLR (Medical, Legal, Regulatory) review process a plus 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job Title: Associate Director-Principal Medical Writer Location: USA, Remote. Proximity to Cambridge/Boston, MA or Morristown, NJ is highly desirable for attending occasional team meetings 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. The Principal Medical Writer is a key member of the Medical Writing team, the Clinical Trial Team (CTT) and Project Team. This is a position for a senior medical writer who has an extensive experience with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission lead. As an integral part of the clinical team, the position holder ensures the quality, compliance with internal and external standards, and timely production of English-language clinical documents regarding both the project as a whole, and individual clinical studies. Our Team: Global Medical writing and Document management serves to generate timely, high quality, cost effective and regulatory compliant documents. Our mission is to synergize and harness evolving technologies pushing the edge of regulatory writing. 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: More specifically the position holder, is responsible for the timely preparation and/or coordination, in English, of reports and/or related regulatory documentation (in some cases of extremely time-critical documentation), required for the planning, initiation, performance and reporting of clinical studies and for marketing approvals worldwide. This work involves close cooperation with members of the CTT and Project Team, as well as colleagues within Clinical Documentation. must provide dedicated scientific authoring expertise to ensure that the clinical opinion, as defined by the Clinical Study Director and the Therapeutic Department Head, is presented accurately and concisely. may need to liaise with external services and review documentation generated elsewhere (e.g. Clinical Research Organisations (CROs), subsidiaries, co-development partners), and internal support staff (e.g. for the preparation of tables, illustrations and appendices). in addition to bringing the required medical writing skills and industry experience, must be willing and able to take responsibility for the mentoring and/or training of more junior colleagues, management of Clinical Documentation teams, maintaining close contact with external departments, and the coordination of external contractors. In addition, he/she is the Clinical Documentation representative in transversal initiatives to contribute to the implementation of process improvement. He /she leads projects in view of developing innovative solutions and technologies (e.g. content re-use, AI) to bring efficiencies and cost savings. He/she contributes to training preparation and delivery, and provides support to the medical writing teams. Principal duties and responsibilities Produce and update clinical documents in a timely manner for study start, conduct and completion, as well as regulatory submissions according to company standards and procedures with the ultimate aim to gain regulatory approval of therapeutic indications. Coordinate medical writing activities in study teams, including external services. Ensure information sharing among MWs. Submit suggestions for improving or extending the standards of clinical documentation, share experience with other medical writers of accommodating special details of clinical studies not covered by the standards and technical expertise gained with advanced technologies. Review clinical development plans to ensure adequate planning of medical writing activities. Advise team members of regulatory requirements for documentation and propose strategies that provide efficiency gains. Prepare or coordinate the preparation of clinical modules for registration dossier, including overall EU or US clinical regulatory documentation using available standards, and ensure consistency across regulatory documents following database changes or modifications to the registration package. Prepare or coordinate the preparation of responses regarding company drug submission dossiers to Health Authorities. Review and edit work of contract writers to ensure quality is maintained. Build and sustain rapport with clinical personnel, including internal clients and colleagues. Establish effective cross-functional relationships with local and counterparts in other departments, especially Regulatory Operations. Maintain awareness of current clinical documentation requirements for target regulatory agencies. Notify management of any changes to standards and the impact of these changes on systems/processes. Represent Clinical Documentation as Subject Matter Expert on transversal initiatives, concerning content, processes and tools for the implementation of new/updated processes or IT solutions to bring efficiencies, time and/or cost saving. Acts as change agent for the medical writing teams. Share experience with and train other medical writers. In collaboration with ITS, lead transversal project teams in view of the implementation of new technologies for accelerating the preparation of the documents and providing cost saving. About You Knowledge and skills An experience as a Medical Writer of at least 6 years, or equivalent. Ability to clearly, accurately, and concisely prepare all types of clinical documentation, including major submission and/or complex documents in English. Excellent interpersonal and leadership skills. Ability to work both autonomously and collaboratively with transversal teams in a multicultural, multilingual, and geographically dispersed environment. Must be deadline oriented, possesing a sense of urgency, accuracy, and be meticulous and attentive to detail. Technical comfort with electronic document management and word processing software is required, particularly good Microsoft Word skills. Keen interest in exploring and implementing emerging innovative digital technologies, including content reuse strategies and AI-assisted document authoring solutions. Native English speaker or with proven excellent spoken and written English. Possesses a solid work ethic, professionalism, organizational ability, and follow-up skills. Formal Education And/or Experience required Advanced scientific degree, Master or Ph.D. in life sciences, PharmD, or medically qualified. Work experience of more than 6 years as a medical writer or equivalent, or presenting relevant specialist qualifications. Experience as Lead Project MW on multiple types of clinical documents. Professional background documenting an excellent understanding of, and experience in, clinical development, including clinical study performance/methodology, basic statistics, and/or the regulatory environment. Knowledge and skill desirable but non-essential Specific knowledge of company-targeted therapeutic areas is strongly desirable. 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
10/20/2025
Full time
Job Title: Associate Director-Principal Medical Writer Location: USA, Remote. Proximity to Cambridge/Boston, MA or Morristown, NJ is highly desirable for attending occasional team meetings 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. The Principal Medical Writer is a key member of the Medical Writing team, the Clinical Trial Team (CTT) and Project Team. This is a position for a senior medical writer who has an extensive experience with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission lead. As an integral part of the clinical team, the position holder ensures the quality, compliance with internal and external standards, and timely production of English-language clinical documents regarding both the project as a whole, and individual clinical studies. Our Team: Global Medical writing and Document management serves to generate timely, high quality, cost effective and regulatory compliant documents. Our mission is to synergize and harness evolving technologies pushing the edge of regulatory writing. 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: More specifically the position holder, is responsible for the timely preparation and/or coordination, in English, of reports and/or related regulatory documentation (in some cases of extremely time-critical documentation), required for the planning, initiation, performance and reporting of clinical studies and for marketing approvals worldwide. This work involves close cooperation with members of the CTT and Project Team, as well as colleagues within Clinical Documentation. must provide dedicated scientific authoring expertise to ensure that the clinical opinion, as defined by the Clinical Study Director and the Therapeutic Department Head, is presented accurately and concisely. may need to liaise with external services and review documentation generated elsewhere (e.g. Clinical Research Organisations (CROs), subsidiaries, co-development partners), and internal support staff (e.g. for the preparation of tables, illustrations and appendices). in addition to bringing the required medical writing skills and industry experience, must be willing and able to take responsibility for the mentoring and/or training of more junior colleagues, management of Clinical Documentation teams, maintaining close contact with external departments, and the coordination of external contractors. In addition, he/she is the Clinical Documentation representative in transversal initiatives to contribute to the implementation of process improvement. He /she leads projects in view of developing innovative solutions and technologies (e.g. content re-use, AI) to bring efficiencies and cost savings. He/she contributes to training preparation and delivery, and provides support to the medical writing teams. Principal duties and responsibilities Produce and update clinical documents in a timely manner for study start, conduct and completion, as well as regulatory submissions according to company standards and procedures with the ultimate aim to gain regulatory approval of therapeutic indications. Coordinate medical writing activities in study teams, including external services. Ensure information sharing among MWs. Submit suggestions for improving or extending the standards of clinical documentation, share experience with other medical writers of accommodating special details of clinical studies not covered by the standards and technical expertise gained with advanced technologies. Review clinical development plans to ensure adequate planning of medical writing activities. Advise team members of regulatory requirements for documentation and propose strategies that provide efficiency gains. Prepare or coordinate the preparation of clinical modules for registration dossier, including overall EU or US clinical regulatory documentation using available standards, and ensure consistency across regulatory documents following database changes or modifications to the registration package. Prepare or coordinate the preparation of responses regarding company drug submission dossiers to Health Authorities. Review and edit work of contract writers to ensure quality is maintained. Build and sustain rapport with clinical personnel, including internal clients and colleagues. Establish effective cross-functional relationships with local and counterparts in other departments, especially Regulatory Operations. Maintain awareness of current clinical documentation requirements for target regulatory agencies. Notify management of any changes to standards and the impact of these changes on systems/processes. Represent Clinical Documentation as Subject Matter Expert on transversal initiatives, concerning content, processes and tools for the implementation of new/updated processes or IT solutions to bring efficiencies, time and/or cost saving. Acts as change agent for the medical writing teams. Share experience with and train other medical writers. In collaboration with ITS, lead transversal project teams in view of the implementation of new technologies for accelerating the preparation of the documents and providing cost saving. About You Knowledge and skills An experience as a Medical Writer of at least 6 years, or equivalent. Ability to clearly, accurately, and concisely prepare all types of clinical documentation, including major submission and/or complex documents in English. Excellent interpersonal and leadership skills. Ability to work both autonomously and collaboratively with transversal teams in a multicultural, multilingual, and geographically dispersed environment. Must be deadline oriented, possesing a sense of urgency, accuracy, and be meticulous and attentive to detail. Technical comfort with electronic document management and word processing software is required, particularly good Microsoft Word skills. Keen interest in exploring and implementing emerging innovative digital technologies, including content reuse strategies and AI-assisted document authoring solutions. Native English speaker or with proven excellent spoken and written English. Possesses a solid work ethic, professionalism, organizational ability, and follow-up skills. Formal Education And/or Experience required Advanced scientific degree, Master or Ph.D. in life sciences, PharmD, or medically qualified. Work experience of more than 6 years as a medical writer or equivalent, or presenting relevant specialist qualifications. Experience as Lead Project MW on multiple types of clinical documents. Professional background documenting an excellent understanding of, and experience in, clinical development, including clinical study performance/methodology, basic statistics, and/or the regulatory environment. Knowledge and skill desirable but non-essential Specific knowledge of company-targeted therapeutic areas is strongly desirable. 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job Title: Clinical Research Director - RBD Location: Cambridge, MA Morristown, NJ 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. Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Genzyme Corporation (a Sanofi company) 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. The Clinical Research Director (CRD) provides medical and scientific expertise to the creation and implementation of global clinical development plans and other activities within Sanofi Genzyme related to the corporate mission of developing novel and valued therapeutics for patients with high unmet needs. 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 The CRD is expected to be a principal team member within the development group. He/she provides medical and scientific leadership in the development of new therapies. The CRD is responsible for the clinical aspects of the Global Clinical Development Plan (GCDP) and is accountable for the appropriate design, execution, and analyses of clinical trials within the GCDP. The CRD will become an expert in the disease and experimental therapy for which he/she is responsible. This expertise should be developed and maintained through background medical education, proficiency in current scientific literature, attendance and participation in scientific conferences and relationships with external experts. The CRD will maintain up to date knowledge of practices and scientific literature in the therapeutic area and communicate developments to appropriate internal staff. The CRD works with the Clinical Science Operation (CSO) team to implement selected clinical trial(s) within the GCDP, including study initiation, study conduct and preparation of study reports. The CRD leads the Clinical Development Subteam (CDST) working closely with the CSO Project Lead (PL) and is accountable for the development of the clinical development strategy. In this role, the CRD provides clinical input and leadership into the activities of this team in close collaboration with the Global Project Head (GPH) and Project Manager (PM), including the relevant components of the GCDP in accordance with the product profile and corporate goals. In the creation and implementation of the GCDP, the CRD has a leadership role in partnership with other members of the CDST (i.e., GPH, CSO PL, regulatory, statistics, and PM) The CRD will lead the preparation of clinical documents/reports for regulatory submission and will attend meetings with regulatory authorities. The CRD will work in conjunction with the Commercial and Medical Affairs to support the creation of the product value proposition and global product positioning. In support of licensing and acquisition activities, the CRD will work in concert with business development and provide medical due diligence on opportunities. The CRD will liaise with the Medical Affairs group to contribute to activities such as review and approval of investigator sponsored studies, contribution to and review of manuscripts that involve Sanofi sponsored studies. The CRD will liaise with the Research group in the therapeutic area, contributing to the overall science discovery strategy and providing medical assessment of disease and therapeutic targets. About You Basic Qualifications: MD 5 + years of pharmaceutical/biotechnology industry or combined industry/ academic experience, with experience in clinical trials A working knowledge of GCP Preferred Qualifications: Specialization in hematology preferred Academic experience as a principal investigator a plus Strong analytic thinking and the ability to assess scientific data and medical literature Excellent written and verbal communication skills. Experience writing abstracts/manuscripts/study reports strongly desired Collaborative team work ethic. Ability to work and lead a matrix team 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
10/20/2025
Full time
Job Title: Clinical Research Director - RBD Location: Cambridge, MA Morristown, NJ 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. Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Genzyme Corporation (a Sanofi company) 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. The Clinical Research Director (CRD) provides medical and scientific expertise to the creation and implementation of global clinical development plans and other activities within Sanofi Genzyme related to the corporate mission of developing novel and valued therapeutics for patients with high unmet needs. 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 The CRD is expected to be a principal team member within the development group. He/she provides medical and scientific leadership in the development of new therapies. The CRD is responsible for the clinical aspects of the Global Clinical Development Plan (GCDP) and is accountable for the appropriate design, execution, and analyses of clinical trials within the GCDP. The CRD will become an expert in the disease and experimental therapy for which he/she is responsible. This expertise should be developed and maintained through background medical education, proficiency in current scientific literature, attendance and participation in scientific conferences and relationships with external experts. The CRD will maintain up to date knowledge of practices and scientific literature in the therapeutic area and communicate developments to appropriate internal staff. The CRD works with the Clinical Science Operation (CSO) team to implement selected clinical trial(s) within the GCDP, including study initiation, study conduct and preparation of study reports. The CRD leads the Clinical Development Subteam (CDST) working closely with the CSO Project Lead (PL) and is accountable for the development of the clinical development strategy. In this role, the CRD provides clinical input and leadership into the activities of this team in close collaboration with the Global Project Head (GPH) and Project Manager (PM), including the relevant components of the GCDP in accordance with the product profile and corporate goals. In the creation and implementation of the GCDP, the CRD has a leadership role in partnership with other members of the CDST (i.e., GPH, CSO PL, regulatory, statistics, and PM) The CRD will lead the preparation of clinical documents/reports for regulatory submission and will attend meetings with regulatory authorities. The CRD will work in conjunction with the Commercial and Medical Affairs to support the creation of the product value proposition and global product positioning. In support of licensing and acquisition activities, the CRD will work in concert with business development and provide medical due diligence on opportunities. The CRD will liaise with the Medical Affairs group to contribute to activities such as review and approval of investigator sponsored studies, contribution to and review of manuscripts that involve Sanofi sponsored studies. The CRD will liaise with the Research group in the therapeutic area, contributing to the overall science discovery strategy and providing medical assessment of disease and therapeutic targets. About You Basic Qualifications: MD 5 + years of pharmaceutical/biotechnology industry or combined industry/ academic experience, with experience in clinical trials A working knowledge of GCP Preferred Qualifications: Specialization in hematology preferred Academic experience as a principal investigator a plus Strong analytic thinking and the ability to assess scientific data and medical literature Excellent written and verbal communication skills. Experience writing abstracts/manuscripts/study reports strongly desired Collaborative team work ethic. Ability to work and lead a matrix team 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job Title: Associate Director, Market Access Training Location: Cambridge, MA Morristown, NJ About the Job Sanofi has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases, multiple sclerosis, immunology and oncology, we are dedicated to making a positive impact on the lives of the patients and families we serve. Sanofi's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. Sanofi's reach and resources makes us one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. At Sanofi, we chase the miracles of science to improve people's lives. Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and specialty care. The Sanofi Associate Director Market Access Training, reports to the Head of Strategy and Operations for US Market Access and is based in Cambridge, MA or Morristown, NJ. The Lead, US Market Access Training is responsible for developing and implementing comprehensive training programs that enable the Market Access team to effectively engage with payers, integrated delivery networks, and other healthcare stakeholders. This role will drive the strategic direction of Market Access training initiatives, ensuring all team members possess the knowledge, skills, and tools necessary to successfully navigate the complex US healthcare landscape and deliver exceptional value to both internal and external customers. This includes responsibility for implementation, measurement, and continuous improvement to the following work streams: We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Main Responsibilities: Training Strategy & Development: Develop and execute an annual training plan aligned with business objectives and market access strategies Design, implement, and evaluate market access training programs, including new hire onboarding, ongoing skill development, and advanced market access concepts Create innovative learning solutions that address identified knowledge gaps and enhance team capabilities Establish metrics to measure training effectiveness and impact on business outcomes Cross-Functional Collaboration Partner closely with Access Strategy and Account Teams to identify training needs and develop targeted solutions Work with compliance to ensure all training materials and programs adhere to industry regulations and company policies Engage with external vendors and subject matter experts to supplement internal training resources Collaborate with GTMC (Go To Market Capabilities) learning and development teams to bring Sanofi development programs to US Market Access Content Development & Delivery Develop comprehensive training materials including presentations, e-learning modules, job aids, Echo flash cards and reference guides Facilitate live training sessions, workshops, and role-playing exercises Implement blended learning approaches to accommodate different learning styles and operational constraints Maintain and update training content to reflect new launches and company strategies Ensure training content is updated and compliant Lead the measurement and feedback of all training programs Develop and maintain new hire training programs and curriculum Lead the coordination and assist in the facilitation of all Market Access Role New Hire training About You Basic Qualifications: BA/BS Degree required, preferably in life science or business. MBA a plus. The ideal candidate will have 5 plus years of relevant pharmaceutical/biotech industry experience Proven communication skills with a well-developed ability to efficiently and productively communicate both verbally and in writing Highly organized, with strong project management skills Demonstrate excellence in building workshops for brand/product and advanced sales skills Ability to influence, collaborate and interact effectively a senior leadership team and multiple key stakeholders across sales and marketing to align objectives and provide consistent training direction Demonstrated excellence in project management and effectively managing multiple projects/priorities including budgeting and actual spend against budget is required Ensure that all training programs are consistent with, and supporting of, company legal, regulatory and compliance guidelines 25-35% national travel required Preferred Qualifications Market Access Experience Training or Learning Design experience Excellent verbal & written communication skills essential to success in this position Strong collaboration, organizational and operations skills Ideal candidate will have experience in specialty pharmaceuticals or biologics market access, with a background in infusible products, specialty pharmacy, and buy & bill, and product launch 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
10/20/2025
Full time
Job Title: Associate Director, Market Access Training Location: Cambridge, MA Morristown, NJ About the Job Sanofi has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases, multiple sclerosis, immunology and oncology, we are dedicated to making a positive impact on the lives of the patients and families we serve. Sanofi's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. Sanofi's reach and resources makes us one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. At Sanofi, we chase the miracles of science to improve people's lives. Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and specialty care. The Sanofi Associate Director Market Access Training, reports to the Head of Strategy and Operations for US Market Access and is based in Cambridge, MA or Morristown, NJ. The Lead, US Market Access Training is responsible for developing and implementing comprehensive training programs that enable the Market Access team to effectively engage with payers, integrated delivery networks, and other healthcare stakeholders. This role will drive the strategic direction of Market Access training initiatives, ensuring all team members possess the knowledge, skills, and tools necessary to successfully navigate the complex US healthcare landscape and deliver exceptional value to both internal and external customers. This includes responsibility for implementation, measurement, and continuous improvement to the following work streams: We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Main Responsibilities: Training Strategy & Development: Develop and execute an annual training plan aligned with business objectives and market access strategies Design, implement, and evaluate market access training programs, including new hire onboarding, ongoing skill development, and advanced market access concepts Create innovative learning solutions that address identified knowledge gaps and enhance team capabilities Establish metrics to measure training effectiveness and impact on business outcomes Cross-Functional Collaboration Partner closely with Access Strategy and Account Teams to identify training needs and develop targeted solutions Work with compliance to ensure all training materials and programs adhere to industry regulations and company policies Engage with external vendors and subject matter experts to supplement internal training resources Collaborate with GTMC (Go To Market Capabilities) learning and development teams to bring Sanofi development programs to US Market Access Content Development & Delivery Develop comprehensive training materials including presentations, e-learning modules, job aids, Echo flash cards and reference guides Facilitate live training sessions, workshops, and role-playing exercises Implement blended learning approaches to accommodate different learning styles and operational constraints Maintain and update training content to reflect new launches and company strategies Ensure training content is updated and compliant Lead the measurement and feedback of all training programs Develop and maintain new hire training programs and curriculum Lead the coordination and assist in the facilitation of all Market Access Role New Hire training About You Basic Qualifications: BA/BS Degree required, preferably in life science or business. MBA a plus. The ideal candidate will have 5 plus years of relevant pharmaceutical/biotech industry experience Proven communication skills with a well-developed ability to efficiently and productively communicate both verbally and in writing Highly organized, with strong project management skills Demonstrate excellence in building workshops for brand/product and advanced sales skills Ability to influence, collaborate and interact effectively a senior leadership team and multiple key stakeholders across sales and marketing to align objectives and provide consistent training direction Demonstrated excellence in project management and effectively managing multiple projects/priorities including budgeting and actual spend against budget is required Ensure that all training programs are consistent with, and supporting of, company legal, regulatory and compliance guidelines 25-35% national travel required Preferred Qualifications Market Access Experience Training or Learning Design experience Excellent verbal & written communication skills essential to success in this position Strong collaboration, organizational and operations skills Ideal candidate will have experience in specialty pharmaceuticals or biologics market access, with a background in infusible products, specialty pharmacy, and buy & bill, and product launch 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job Title: Associate Director-Principal Medical Writer Location: USA, Remote. Proximity to Cambridge/Boston, MA or Morristown, NJ is highly desirable for attending occasional team meetings 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. The Principal Medical Writer is a key member of the Medical Writing team, the Clinical Trial Team (CTT) and Project Team. This is a position for a senior medical writer who has an extensive experience with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission lead. As an integral part of the clinical team, the position holder ensures the quality, compliance with internal and external standards, and timely production of English-language clinical documents regarding both the project as a whole, and individual clinical studies. Our Team: Global Medical writing and Document management serves to generate timely, high quality, cost effective and regulatory compliant documents. Our mission is to synergize and harness evolving technologies pushing the edge of regulatory writing. 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: More specifically the position holder, is responsible for the timely preparation and/or coordination, in English, of reports and/or related regulatory documentation (in some cases of extremely time-critical documentation), required for the planning, initiation, performance and reporting of clinical studies and for marketing approvals worldwide. This work involves close cooperation with members of the CTT and Project Team, as well as colleagues within Clinical Documentation. must provide dedicated scientific authoring expertise to ensure that the clinical opinion, as defined by the Clinical Study Director and the Therapeutic Department Head, is presented accurately and concisely. may need to liaise with external services and review documentation generated elsewhere (e.g. Clinical Research Organisations (CROs), subsidiaries, co-development partners), and internal support staff (e.g. for the preparation of tables, illustrations and appendices). in addition to bringing the required medical writing skills and industry experience, must be willing and able to take responsibility for the mentoring and/or training of more junior colleagues, management of Clinical Documentation teams, maintaining close contact with external departments, and the coordination of external contractors. In addition, he/she is the Clinical Documentation representative in transversal initiatives to contribute to the implementation of process improvement. He /she leads projects in view of developing innovative solutions and technologies (e.g. content re-use, AI) to bring efficiencies and cost savings. He/she contributes to training preparation and delivery, and provides support to the medical writing teams. Principal duties and responsibilities Produce and update clinical documents in a timely manner for study start, conduct and completion, as well as regulatory submissions according to company standards and procedures with the ultimate aim to gain regulatory approval of therapeutic indications. Coordinate medical writing activities in study teams, including external services. Ensure information sharing among MWs. Submit suggestions for improving or extending the standards of clinical documentation, share experience with other medical writers of accommodating special details of clinical studies not covered by the standards and technical expertise gained with advanced technologies. Review clinical development plans to ensure adequate planning of medical writing activities. Advise team members of regulatory requirements for documentation and propose strategies that provide efficiency gains. Prepare or coordinate the preparation of clinical modules for registration dossier, including overall EU or US clinical regulatory documentation using available standards, and ensure consistency across regulatory documents following database changes or modifications to the registration package. Prepare or coordinate the preparation of responses regarding company drug submission dossiers to Health Authorities. Review and edit work of contract writers to ensure quality is maintained. Build and sustain rapport with clinical personnel, including internal clients and colleagues. Establish effective cross-functional relationships with local and counterparts in other departments, especially Regulatory Operations. Maintain awareness of current clinical documentation requirements for target regulatory agencies. Notify management of any changes to standards and the impact of these changes on systems/processes. Represent Clinical Documentation as Subject Matter Expert on transversal initiatives, concerning content, processes and tools for the implementation of new/updated processes or IT solutions to bring efficiencies, time and/or cost saving. Acts as change agent for the medical writing teams. Share experience with and train other medical writers. In collaboration with ITS, lead transversal project teams in view of the implementation of new technologies for accelerating the preparation of the documents and providing cost saving. About You Knowledge and skills An experience as a Medical Writer of at least 6 years, or equivalent. Ability to clearly, accurately, and concisely prepare all types of clinical documentation, including major submission and/or complex documents in English. Excellent interpersonal and leadership skills. Ability to work both autonomously and collaboratively with transversal teams in a multicultural, multilingual, and geographically dispersed environment. Must be deadline oriented, possesing a sense of urgency, accuracy, and be meticulous and attentive to detail. Technical comfort with electronic document management and word processing software is required, particularly good Microsoft Word skills. Keen interest in exploring and implementing emerging innovative digital technologies, including content reuse strategies and AI-assisted document authoring solutions. Native English speaker or with proven excellent spoken and written English. Possesses a solid work ethic, professionalism, organizational ability, and follow-up skills Formal Education And/or Experience required Advanced scientific degree, Master or Ph.D. in life sciences, PharmD, or medically qualified. Work experience of more than 6 years as a medical writer or equivalent, or presenting relevant specialist qualifications. Experience as Lead Project MW on multiple types of clinical documents. Professional background documenting an excellent understanding of, and experience in, clinical development, including clinical study performance/methodology, basic statistics, and/or the regulatory environment. Knowledge and skill desirable but non-essential Specific knowledge of company-targeted therapeutic areas is strongly desirable. 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. 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. . click apply for full job details
10/20/2025
Full time
Job Title: Associate Director-Principal Medical Writer Location: USA, Remote. Proximity to Cambridge/Boston, MA or Morristown, NJ is highly desirable for attending occasional team meetings 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. The Principal Medical Writer is a key member of the Medical Writing team, the Clinical Trial Team (CTT) and Project Team. This is a position for a senior medical writer who has an extensive experience with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission lead. As an integral part of the clinical team, the position holder ensures the quality, compliance with internal and external standards, and timely production of English-language clinical documents regarding both the project as a whole, and individual clinical studies. Our Team: Global Medical writing and Document management serves to generate timely, high quality, cost effective and regulatory compliant documents. Our mission is to synergize and harness evolving technologies pushing the edge of regulatory writing. 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: More specifically the position holder, is responsible for the timely preparation and/or coordination, in English, of reports and/or related regulatory documentation (in some cases of extremely time-critical documentation), required for the planning, initiation, performance and reporting of clinical studies and for marketing approvals worldwide. This work involves close cooperation with members of the CTT and Project Team, as well as colleagues within Clinical Documentation. must provide dedicated scientific authoring expertise to ensure that the clinical opinion, as defined by the Clinical Study Director and the Therapeutic Department Head, is presented accurately and concisely. may need to liaise with external services and review documentation generated elsewhere (e.g. Clinical Research Organisations (CROs), subsidiaries, co-development partners), and internal support staff (e.g. for the preparation of tables, illustrations and appendices). in addition to bringing the required medical writing skills and industry experience, must be willing and able to take responsibility for the mentoring and/or training of more junior colleagues, management of Clinical Documentation teams, maintaining close contact with external departments, and the coordination of external contractors. In addition, he/she is the Clinical Documentation representative in transversal initiatives to contribute to the implementation of process improvement. He /she leads projects in view of developing innovative solutions and technologies (e.g. content re-use, AI) to bring efficiencies and cost savings. He/she contributes to training preparation and delivery, and provides support to the medical writing teams. Principal duties and responsibilities Produce and update clinical documents in a timely manner for study start, conduct and completion, as well as regulatory submissions according to company standards and procedures with the ultimate aim to gain regulatory approval of therapeutic indications. Coordinate medical writing activities in study teams, including external services. Ensure information sharing among MWs. Submit suggestions for improving or extending the standards of clinical documentation, share experience with other medical writers of accommodating special details of clinical studies not covered by the standards and technical expertise gained with advanced technologies. Review clinical development plans to ensure adequate planning of medical writing activities. Advise team members of regulatory requirements for documentation and propose strategies that provide efficiency gains. Prepare or coordinate the preparation of clinical modules for registration dossier, including overall EU or US clinical regulatory documentation using available standards, and ensure consistency across regulatory documents following database changes or modifications to the registration package. Prepare or coordinate the preparation of responses regarding company drug submission dossiers to Health Authorities. Review and edit work of contract writers to ensure quality is maintained. Build and sustain rapport with clinical personnel, including internal clients and colleagues. Establish effective cross-functional relationships with local and counterparts in other departments, especially Regulatory Operations. Maintain awareness of current clinical documentation requirements for target regulatory agencies. Notify management of any changes to standards and the impact of these changes on systems/processes. Represent Clinical Documentation as Subject Matter Expert on transversal initiatives, concerning content, processes and tools for the implementation of new/updated processes or IT solutions to bring efficiencies, time and/or cost saving. Acts as change agent for the medical writing teams. Share experience with and train other medical writers. In collaboration with ITS, lead transversal project teams in view of the implementation of new technologies for accelerating the preparation of the documents and providing cost saving. About You Knowledge and skills An experience as a Medical Writer of at least 6 years, or equivalent. Ability to clearly, accurately, and concisely prepare all types of clinical documentation, including major submission and/or complex documents in English. Excellent interpersonal and leadership skills. Ability to work both autonomously and collaboratively with transversal teams in a multicultural, multilingual, and geographically dispersed environment. Must be deadline oriented, possesing a sense of urgency, accuracy, and be meticulous and attentive to detail. Technical comfort with electronic document management and word processing software is required, particularly good Microsoft Word skills. Keen interest in exploring and implementing emerging innovative digital technologies, including content reuse strategies and AI-assisted document authoring solutions. Native English speaker or with proven excellent spoken and written English. Possesses a solid work ethic, professionalism, organizational ability, and follow-up skills Formal Education And/or Experience required Advanced scientific degree, Master or Ph.D. in life sciences, PharmD, or medically qualified. Work experience of more than 6 years as a medical writer or equivalent, or presenting relevant specialist qualifications. Experience as Lead Project MW on multiple types of clinical documents. Professional background documenting an excellent understanding of, and experience in, clinical development, including clinical study performance/methodology, basic statistics, and/or the regulatory environment. Knowledge and skill desirable but non-essential Specific knowledge of company-targeted therapeutic areas is strongly desirable. 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. 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. . click apply for full job details
Job Title: Associate Director-Principal Medical Writer Location: USA, Remote. Proximity to Cambridge/Boston, MA or Morristown, NJ is highly desirable for attending occasional team meetings 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. The Principal Medical Writer is a key member of the Medical Writing team, the Clinical Trial Team (CTT) and Project Team. This is a position for a senior medical writer who has an extensive experience with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission lead. As an integral part of the clinical team, the position holder ensures the quality, compliance with internal and external standards, and timely production of English-language clinical documents regarding both the project as a whole, and individual clinical studies. Our Team: Global Medical writing and Document management serves to generate timely, high quality, cost effective and regulatory compliant documents. Our mission is to synergize and harness evolving technologies pushing the edge of regulatory writing. 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: More specifically the position holder, is responsible for the timely preparation and/or coordination, in English, of reports and/or related regulatory documentation (in some cases of extremely time-critical documentation), required for the planning, initiation, performance and reporting of clinical studies and for marketing approvals worldwide. This work involves close cooperation with members of the CTT and Project Team, as well as colleagues within Clinical Documentation. must provide dedicated scientific authoring expertise to ensure that the clinical opinion, as defined by the Clinical Study Director and the Therapeutic Department Head, is presented accurately and concisely. may need to liaise with external services and review documentation generated elsewhere (e.g. Clinical Research Organisations (CROs), subsidiaries, co-development partners), and internal support staff (e.g. for the preparation of tables, illustrations and appendices). in addition to bringing the required medical writing skills and industry experience, must be willing and able to take responsibility for the mentoring and/or training of more junior colleagues, management of Clinical Documentation teams, maintaining close contact with external departments, and the coordination of external contractors. In addition, he/she is the Clinical Documentation representative in transversal initiatives to contribute to the implementation of process improvement. He /she leads projects in view of developing innovative solutions and technologies (e.g. content re-use, AI) to bring efficiencies and cost savings. He/she contributes to training preparation and delivery, and provides support to the medical writing teams. Principal duties and responsibilities Produce and update clinical documents in a timely manner for study start, conduct and completion, as well as regulatory submissions according to company standards and procedures with the ultimate aim to gain regulatory approval of therapeutic indications. Coordinate medical writing activities in study teams, including external services. Ensure information sharing among MWs. Submit suggestions for improving or extending the standards of clinical documentation, share experience with other medical writers of accommodating special details of clinical studies not covered by the standards and technical expertise gained with advanced technologies. Review clinical development plans to ensure adequate planning of medical writing activities. Advise team members of regulatory requirements for documentation and propose strategies that provide efficiency gains. Prepare or coordinate the preparation of clinical modules for registration dossier, including overall EU or US clinical regulatory documentation using available standards, and ensure consistency across regulatory documents following database changes or modifications to the registration package. Prepare or coordinate the preparation of responses regarding company drug submission dossiers to Health Authorities. Review and edit work of contract writers to ensure quality is maintained. Build and sustain rapport with clinical personnel, including internal clients and colleagues. Establish effective cross-functional relationships with local and counterparts in other departments, especially Regulatory Operations. Maintain awareness of current clinical documentation requirements for target regulatory agencies. Notify management of any changes to standards and the impact of these changes on systems/processes. Represent Clinical Documentation as Subject Matter Expert on transversal initiatives, concerning content, processes and tools for the implementation of new/updated processes or IT solutions to bring efficiencies, time and/or cost saving. Acts as change agent for the medical writing teams. Share experience with and train other medical writers. In collaboration with ITS, lead transversal project teams in view of the implementation of new technologies for accelerating the preparation of the documents and providing cost saving. About You Knowledge and skills An experience as a Medical Writer of at least 6 years, or equivalent. Ability to clearly, accurately, and concisely prepare all types of clinical documentation, including major submission and/or complex documents in English. Excellent interpersonal and leadership skills. Ability to work both autonomously and collaboratively with transversal teams in a multicultural, multilingual, and geographically dispersed environment. Must be deadline oriented, possesing a sense of urgency, accuracy, and be meticulous and attentive to detail. Technical comfort with electronic document management and word processing software is required, particularly good Microsoft Word skills. Keen interest in exploring and implementing emerging innovative digital technologies, including content reuse strategies and AI-assisted document authoring solutions. Native English speaker or with proven excellent spoken and written English. Possesses a solid work ethic, professionalism, organizational ability, and follow-up skills. Formal Education And/or Experience required Advanced scientific degree, Master or Ph.D. in life sciences, PharmD, or medically qualified. Work experience of more than 6 years as a medical writer or equivalent, or presenting relevant specialist qualifications. Experience as Lead Project MW on multiple types of clinical documents. Professional background documenting an excellent understanding of, and experience in, clinical development, including clinical study performance/methodology, basic statistics, and/or the regulatory environment. Knowledge and skill desirable but non-essential Specific knowledge of company-targeted therapeutic areas is strongly desirable. 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
10/20/2025
Full time
Job Title: Associate Director-Principal Medical Writer Location: USA, Remote. Proximity to Cambridge/Boston, MA or Morristown, NJ is highly desirable for attending occasional team meetings 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. The Principal Medical Writer is a key member of the Medical Writing team, the Clinical Trial Team (CTT) and Project Team. This is a position for a senior medical writer who has an extensive experience with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission lead. As an integral part of the clinical team, the position holder ensures the quality, compliance with internal and external standards, and timely production of English-language clinical documents regarding both the project as a whole, and individual clinical studies. Our Team: Global Medical writing and Document management serves to generate timely, high quality, cost effective and regulatory compliant documents. Our mission is to synergize and harness evolving technologies pushing the edge of regulatory writing. 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: More specifically the position holder, is responsible for the timely preparation and/or coordination, in English, of reports and/or related regulatory documentation (in some cases of extremely time-critical documentation), required for the planning, initiation, performance and reporting of clinical studies and for marketing approvals worldwide. This work involves close cooperation with members of the CTT and Project Team, as well as colleagues within Clinical Documentation. must provide dedicated scientific authoring expertise to ensure that the clinical opinion, as defined by the Clinical Study Director and the Therapeutic Department Head, is presented accurately and concisely. may need to liaise with external services and review documentation generated elsewhere (e.g. Clinical Research Organisations (CROs), subsidiaries, co-development partners), and internal support staff (e.g. for the preparation of tables, illustrations and appendices). in addition to bringing the required medical writing skills and industry experience, must be willing and able to take responsibility for the mentoring and/or training of more junior colleagues, management of Clinical Documentation teams, maintaining close contact with external departments, and the coordination of external contractors. In addition, he/she is the Clinical Documentation representative in transversal initiatives to contribute to the implementation of process improvement. He /she leads projects in view of developing innovative solutions and technologies (e.g. content re-use, AI) to bring efficiencies and cost savings. He/she contributes to training preparation and delivery, and provides support to the medical writing teams. Principal duties and responsibilities Produce and update clinical documents in a timely manner for study start, conduct and completion, as well as regulatory submissions according to company standards and procedures with the ultimate aim to gain regulatory approval of therapeutic indications. Coordinate medical writing activities in study teams, including external services. Ensure information sharing among MWs. Submit suggestions for improving or extending the standards of clinical documentation, share experience with other medical writers of accommodating special details of clinical studies not covered by the standards and technical expertise gained with advanced technologies. Review clinical development plans to ensure adequate planning of medical writing activities. Advise team members of regulatory requirements for documentation and propose strategies that provide efficiency gains. Prepare or coordinate the preparation of clinical modules for registration dossier, including overall EU or US clinical regulatory documentation using available standards, and ensure consistency across regulatory documents following database changes or modifications to the registration package. Prepare or coordinate the preparation of responses regarding company drug submission dossiers to Health Authorities. Review and edit work of contract writers to ensure quality is maintained. Build and sustain rapport with clinical personnel, including internal clients and colleagues. Establish effective cross-functional relationships with local and counterparts in other departments, especially Regulatory Operations. Maintain awareness of current clinical documentation requirements for target regulatory agencies. Notify management of any changes to standards and the impact of these changes on systems/processes. Represent Clinical Documentation as Subject Matter Expert on transversal initiatives, concerning content, processes and tools for the implementation of new/updated processes or IT solutions to bring efficiencies, time and/or cost saving. Acts as change agent for the medical writing teams. Share experience with and train other medical writers. In collaboration with ITS, lead transversal project teams in view of the implementation of new technologies for accelerating the preparation of the documents and providing cost saving. About You Knowledge and skills An experience as a Medical Writer of at least 6 years, or equivalent. Ability to clearly, accurately, and concisely prepare all types of clinical documentation, including major submission and/or complex documents in English. Excellent interpersonal and leadership skills. Ability to work both autonomously and collaboratively with transversal teams in a multicultural, multilingual, and geographically dispersed environment. Must be deadline oriented, possesing a sense of urgency, accuracy, and be meticulous and attentive to detail. Technical comfort with electronic document management and word processing software is required, particularly good Microsoft Word skills. Keen interest in exploring and implementing emerging innovative digital technologies, including content reuse strategies and AI-assisted document authoring solutions. Native English speaker or with proven excellent spoken and written English. Possesses a solid work ethic, professionalism, organizational ability, and follow-up skills. Formal Education And/or Experience required Advanced scientific degree, Master or Ph.D. in life sciences, PharmD, or medically qualified. Work experience of more than 6 years as a medical writer or equivalent, or presenting relevant specialist qualifications. Experience as Lead Project MW on multiple types of clinical documents. Professional background documenting an excellent understanding of, and experience in, clinical development, including clinical study performance/methodology, basic statistics, and/or the regulatory environment. Knowledge and skill desirable but non-essential Specific knowledge of company-targeted therapeutic areas is strongly desirable. 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job Title: Clinical Research Director - RBD Location: Cambridge, MA Morristown, NJ 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. Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Genzyme Corporation (a Sanofi company) 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. The Clinical Research Director (CRD) provides medical and scientific expertise to the creation and implementation of global clinical development plans and other activities within Sanofi Genzyme related to the corporate mission of developing novel and valued therapeutics for patients with high unmet needs. 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 The CRD is expected to be a principal team member within the development group. He/she provides medical and scientific leadership in the development of new therapies. The CRD is responsible for the clinical aspects of the Global Clinical Development Plan (GCDP) and is accountable for the appropriate design, execution, and analyses of clinical trials within the GCDP. The CRD will become an expert in the disease and experimental therapy for which he/she is responsible. This expertise should be developed and maintained through background medical education, proficiency in current scientific literature, attendance and participation in scientific conferences and relationships with external experts. The CRD will maintain up to date knowledge of practices and scientific literature in the therapeutic area and communicate developments to appropriate internal staff. The CRD works with the Clinical Science Operation (CSO) team to implement selected clinical trial(s) within the GCDP, including study initiation, study conduct and preparation of study reports. The CRD leads the Clinical Development Subteam (CDST) working closely with the CSO Project Lead (PL) and is accountable for the development of the clinical development strategy. In this role, the CRD provides clinical input and leadership into the activities of this team in close collaboration with the Global Project Head (GPH) and Project Manager (PM), including the relevant components of the GCDP in accordance with the product profile and corporate goals. In the creation and implementation of the GCDP, the CRD has a leadership role in partnership with other members of the CDST (i.e., GPH, CSO PL, regulatory, statistics, and PM) The CRD will lead the preparation of clinical documents/reports for regulatory submission and will attend meetings with regulatory authorities. The CRD will work in conjunction with the Commercial and Medical Affairs to support the creation of the product value proposition and global product positioning. In support of licensing and acquisition activities, the CRD will work in concert with business development and provide medical due diligence on opportunities. The CRD will liaise with the Medical Affairs group to contribute to activities such as review and approval of investigator sponsored studies, contribution to and review of manuscripts that involve Sanofi sponsored studies. The CRD will liaise with the Research group in the therapeutic area, contributing to the overall science discovery strategy and providing medical assessment of disease and therapeutic targets. About You Basic Qualifications: MD 5 + years of pharmaceutical/biotechnology industry or combined industry/ academic experience, with experience in clinical trials A working knowledge of GCP Preferred Qualifications: Specialization in hematology preferred Academic experience as a principal investigator a plus Strong analytic thinking and the ability to assess scientific data and medical literature Excellent written and verbal communication skills. Experience writing abstracts/manuscripts/study reports strongly desired Collaborative team work ethic. Ability to work and lead a matrix team 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
10/20/2025
Full time
Job Title: Clinical Research Director - RBD Location: Cambridge, MA Morristown, NJ 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. Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Genzyme Corporation (a Sanofi company) 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. The Clinical Research Director (CRD) provides medical and scientific expertise to the creation and implementation of global clinical development plans and other activities within Sanofi Genzyme related to the corporate mission of developing novel and valued therapeutics for patients with high unmet needs. 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 The CRD is expected to be a principal team member within the development group. He/she provides medical and scientific leadership in the development of new therapies. The CRD is responsible for the clinical aspects of the Global Clinical Development Plan (GCDP) and is accountable for the appropriate design, execution, and analyses of clinical trials within the GCDP. The CRD will become an expert in the disease and experimental therapy for which he/she is responsible. This expertise should be developed and maintained through background medical education, proficiency in current scientific literature, attendance and participation in scientific conferences and relationships with external experts. The CRD will maintain up to date knowledge of practices and scientific literature in the therapeutic area and communicate developments to appropriate internal staff. The CRD works with the Clinical Science Operation (CSO) team to implement selected clinical trial(s) within the GCDP, including study initiation, study conduct and preparation of study reports. The CRD leads the Clinical Development Subteam (CDST) working closely with the CSO Project Lead (PL) and is accountable for the development of the clinical development strategy. In this role, the CRD provides clinical input and leadership into the activities of this team in close collaboration with the Global Project Head (GPH) and Project Manager (PM), including the relevant components of the GCDP in accordance with the product profile and corporate goals. In the creation and implementation of the GCDP, the CRD has a leadership role in partnership with other members of the CDST (i.e., GPH, CSO PL, regulatory, statistics, and PM) The CRD will lead the preparation of clinical documents/reports for regulatory submission and will attend meetings with regulatory authorities. The CRD will work in conjunction with the Commercial and Medical Affairs to support the creation of the product value proposition and global product positioning. In support of licensing and acquisition activities, the CRD will work in concert with business development and provide medical due diligence on opportunities. The CRD will liaise with the Medical Affairs group to contribute to activities such as review and approval of investigator sponsored studies, contribution to and review of manuscripts that involve Sanofi sponsored studies. The CRD will liaise with the Research group in the therapeutic area, contributing to the overall science discovery strategy and providing medical assessment of disease and therapeutic targets. About You Basic Qualifications: MD 5 + years of pharmaceutical/biotechnology industry or combined industry/ academic experience, with experience in clinical trials A working knowledge of GCP Preferred Qualifications: Specialization in hematology preferred Academic experience as a principal investigator a plus Strong analytic thinking and the ability to assess scientific data and medical literature Excellent written and verbal communication skills. Experience writing abstracts/manuscripts/study reports strongly desired Collaborative team work ethic. Ability to work and lead a matrix team 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
