Medical Regulatory Writer

Job title: GRA Global AdPromo Excellence Lead

• Location: Morristown, NJ - Cambridge, MA

About the job

A hybrid role combining support for global promotional material regulatory review (30%) with transversal excellence activities (70%). The position supports innovation, and operational efficiency across the GRA Advertising and Promotion (GRA AdPromo) organization while maintaining hands-on review expertise to ensure strategic initiatives remain grounded in operational realities.

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world and are supported and enhanced through our diverse portfolio of medical device and diagnostic products. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities:

Global AdPromo Regulatory Review (~30%)

• Work closely with the assigned global business units (commercial and medical) in the development of promotional / non-promotional materials, their review and prior approval. This also includes the review of internal and external documents issued by communication when related to products/diseases. 

• Act as an advisor for the team regarding the review of promotional activities on global level and/or for the local affiliates; 

• Review the regulatory aspects (as indicated in the Sanofi Global internet rules) of internet websites and social media (global). 

• Define the minimal quality standard and processes to be applied worldwide. Support the set up of guidelines / Quality documents on topics related to regulatory requirements around promotional aspects to ensure appropriate communication to the relevant stakeholders; 

• Advise teams on evolving regulatory requirements, industry trends, enforcement actions and complaints related to pharmaceutical advertising and promotion

Excellence Support Activities (~70%)

Innovation & Transformation Support

• Represent GRA AdPromo in transformation programs and cross-functional initiatives

• Support the evaluation and testing of digital tools and Gen AI use cases under guidance from the Excellence Head

• Help compile data and observations for system and process reviews

Stakeholder Coordination

• Support coordination activities with transversal partners and regional teams

• Assist in preparing materials and communications for stakeholder meetings and updates

• Advocate for the AdPromo team's strategic value and priorities 

Operational Excellence Support

• Assist with data collection and documentation for gap analyses of regulatory processes

• Support maintenance of KPI reporting and dashboards by gathering and organizing relevant data

• Help document best practices, process updates, and SOP revisions under senior guidance

Training & Capability Building Support

• Assist in the preparation process documentation for both transversal and regulatory

• Help maintain and update global training materials

• Conduct upskilling sessions with (regional) regulatory teams on digital initiatives

Governance & Ways of Working Support

• Provide administrative and coordination support for GRA AdPromo Governance activities

• Assist in team engagement activities such as town halls and workshops

About you

Education

• BA/BS degree in Pharmaceutical Sciences, Life Sciences, or related discipline required (other degrees considered with relevant experience)

Experience

• 2+ years of experience in the biopharmaceutical industry performing regulatory affairs advertising and promotion review

Required Skills

• Good understanding of global codes and standards including ability to review against the EFPIA and IFPMA standards

• Interpret complex clinical data (eg, CSRs, medical publications)

• Possesses sufficient scientific and clinical knowledge to understand disease states, mechanisms of action, clinical trial design, and statistical concepts relevant to the products being reviewed

• Use data and local SmPC to inform compliant messaging

• Understand review standards for branded, disease awareness, and medical congress content

Preferred Technical & Soft Skills

• Experience supporting transversal and/or digital transformation initiatives like Gen AI, Modular Content, Core Claims, and or other MLR programs.

• Familiarity with regulatory technology systems such as Veeva and basic familiarity with digital tools and platforms (e.g., Microsoft Office, SharePoint)

• Eagerness to learn and grow within regulatory affairs and excellence functions

• Strong attention to detail and commitment to quality in all tasks

• Foundational understanding of pharmaceutical regulatory concepts (or willingness to develop this quickly)

• Good organizational and coordination skills

• Clear and professional written and verbal communication

• Collaborative mindset with the ability to work effectively within a team

• Adaptable and proactive in a fast-paced, evolving environment

Language

• English (fluent required); additional languages beneficial

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.

• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.

• Help improve the lives of millions of people globally by making drug development quicker and more effective.

• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

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.

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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.