Eacademy Sanofi
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 Aff…
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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 Aff…
#J-18808-Ljbffr