Medical Writer
Sanofi
full-time
Posted on:
Location Type: Remote
Location: Remote • New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $100,500 - $145,166 per year
Job Level
Junior
About the role
- Develop regulatory-compliant clinical documents supporting product lifecycle
- Create high-quality regulatory-compliant clinical documents
- Ensure timely delivery while maintaining compliance with company SOPs and guidelines
- Support implementation of new digital technologies and AI solutions
- Participate in process improvements for efficiency gains
- Prepare clinical documents for registration dossiers and Health Authority responses
- Maintain awareness of regulatory documentation requirements
- Work effectively with cross-functional teams
- Update relevant stakeholders on project progress and needs
- Maintain accurate information in planning, tracking, and reporting tools
- Oversee writing activities from vendors
- Review vendor deliverables
- Ensure consistent document style and adherence to company standards
- Build effective relationships with stakeholders and partners
Requirements
- Must be currently enrolled in 2024-2026 Rutgers Sanofi PharmD Fellows Program
- Minimum 1 year as medical writer or equivalent experience in Clinical Research preferably in pharma
- Experience in preparing clinical documents and regulatory submissions
- 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
- Ability to clearly, accurately, and concisely write/prepare clinical documents in English
- Strong attention to detail and deadline management
- Strong organizational and follow-up abilities
- Ability to work independently and in global teams
- Proficiency in electronic document management and Microsoft Office
- Interest in implementing emerging innovative digital technologies, including AI-assisted document authoring solutions.
Benefits
- Health insurance
- Prevention and wellness programs
- Gender-neutral parental leave
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical writingclinical researchregulatory submissionsclinical development processesclinical study methodologybasic statisticsregulatory environmentmedical terminologydocument management systemsauthoring platforms
Soft skills
attention to detaildeadline managementorganizational abilitiesfollow-up abilitiesindependent workteam collaborationcommunication skillsrelationship building
Certifications
Rutgers Sanofi PharmD Fellows Program