Medical Writer

Location: US, Morristown, NJ / M Station

Job type: Full time

About you:

Sanofi is seeking a highly organized, detail-oriented Medical Writer to join our team. In this role, you will develop regulatory-compliant clinical documents supporting our product lifecycle while embracing innovative digital solutions. The ideal candidate will possess excellent communication skills, regulatory acumen, and the ability to work independently on multiple projects within tight deadlines. You should have an in-depth understanding of medical terminology and the ability to interpret complex data for various stakeholders. We are looking for a creative and passionate candidate eager to contribute to our mission of developing innovative solutions to improve people's health and well-being.

Main responsibilities:
 

Document Development

-        Create high-quality regulatory-compliant clinical documents supporting product life cycle

-        Ensure timely delivery while maintaining compliance with company SOPs and guidelines

Innovation

-        Support implementation of new digital technologies and AI solutions

-        Participate in process improvements for efficiency gains

Regulatory Expertise

-        Prepare clinical documents for registration dossiers and Health Authority responses under guidance

-        Maintain awareness of regulatory documentation requirements

Communication

-        Work effectively with cross-functional teams

-        Update relevant stakeholders on project progress and needs

-        Maintain accurate information in planning, tracking, and reporting tools

Coordination

-        Oversee writing activities from vendors

-        Review vendor deliverables

Quality & Training

-        Ensure consistent document style and adherence to company standards

-        Build effective relationships with stakeholders and partners

Knowledge
 

Core Experience:

• Minimum 1 year as medical writer or equivalent experience in Clinical Research preferably in pharma

• Ability to clearly, accurately, and concisely write/prepare clinical documents in English
• Experience in preparing clinical documents and regulatory submissions
   

Clinical Development Knowledge:

• Basic understanding of clinical development processes
• Knowledge of clinical study methodology and basic statistics
• Familiarity with regulatory environment and medical terminology
• Proficient in document management systems and authoring platforms
   

Professional Attributes:

• Strong attention to detail and deadline management
• Strong organizational and follow-up abilities
• Ability to work independently and in global teams
   

Technical skills:

• Proficiency in electronic document management and Microsoft Office
• Interest in implementing emerging innovative digital technologies, including AI-assisted document authoring solutions.
   

Education: Advanced scientific degree in life sciences, PharmD, or medical qualification (MD, clinician, nurse practitioner)

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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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