Meet Life Sciences
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$220,000.00/yr - $275,000.00/yr Director/Senior Director, Medical Writing Position Summary: Reporting to the Vice President of Regulatory Affairs and Medical Writing, the Director/Senior Director will lead and manage the medical writing function. This individual is responsible for the development of high-quality clinical and regulatory documents, ensuring they meet global standards. The role involves close collaboration with cross-functional teams including Clinical, Medical Affairs, CMC, Regulatory, and Quality. Key Responsibilities: Lead the planning, development, and finalization of regulatory documents (e.g., briefing documents, protocols, submission materials, and agency responses). Oversee internal and external (vendor) medical writing resources. Ensure consistency, accuracy, and compliance with global regulatory requirements and ICH guidelines. Manage document timelines, reviews, version control, and submission readiness. Collaborate with subject matter experts across R&D to capture key information and messaging. Translate complex scientific data into clear, structured content. Design and maintain templated documents on digital platforms for efficient updates and integration. Facilitate structured document reviews and resolve issues to meet deadlines. Qualifications: Bachelor’s or advanced degree in a life sciences discipline. 10+ years of medical or technical writing experience in the pharmaceutical or biotech industry. Proven experience with NDA, BLA, or MAA submissions. Strong understanding of regulatory and clinical development processes. Skilled in using digital collaboration tools (e.g., SharePoint). Excellent writing, editing, and communication skills. Ability to manage multiple projects and collaborate effectively across functions. Please apply directly if your experience aligns! Seniorities
Executive Employment type
Full-time Job function
Writing/Editing Industries Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Meet Life Sciences by 2x Inferred from the description for this job
Medical insurance Vision insurance Paid maternity leave 401(k) Paid paternity leave Get notified when a new job is posted. Sign in to set job alerts for “Medical Writer” roles.
Future Opportunities- Join Our Talent Pipeline for Principal Medical Writers (All Therapeutic Areas) in Medical Affairs
Chicago, IL $56,000.00-$84,000.00 6 days ago Chicago, IL $65,000.00-$75,000.00 1 week ago Scientific Content Developer, Technical Writer III
North Chicago, IL $52.00-$55.00 1 week ago Future Opportunities- Join Our Talent Pipeline for Principal Medical Writers (All Therapeutic)
Chicago, IL $60,000.00-$70,000.00 7 hours ago Evanston, IL $68,000.00-$75,000.00 2 weeks ago Streeterville, IL $65,520.00-$107,120.00 2 months ago In-House Clinical Research Associate (CRA)
Chicago, IL $60,000.00-$100,000.00 1 week ago Future Opportunities- Join Our Talent Pipeline for Medical Outcomes and Science Liaison (MOSL) (All Therapeutic Areas)
North Chicago, IL $35,000.00-$172,500.00 5 days ago Research Project Interviewer - Part Time
Decatur, IL $73,960.89-$192,277.06 3 months ago Arlington Heights, IL $17.00-$23.80 2 days ago In-house Clinical Research Associate (CRA)
Chicago, IL $60,000.00-$100,000.00 1 week ago Chicago, IL $50,000.00-$60,000.00 2 weeks ago Associate I, Clinical Pharmacology Scientific Support & Reporting
North Chicago, IL $64,000.00-$122,000.00 4 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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$220,000.00/yr - $275,000.00/yr Director/Senior Director, Medical Writing Position Summary: Reporting to the Vice President of Regulatory Affairs and Medical Writing, the Director/Senior Director will lead and manage the medical writing function. This individual is responsible for the development of high-quality clinical and regulatory documents, ensuring they meet global standards. The role involves close collaboration with cross-functional teams including Clinical, Medical Affairs, CMC, Regulatory, and Quality. Key Responsibilities: Lead the planning, development, and finalization of regulatory documents (e.g., briefing documents, protocols, submission materials, and agency responses). Oversee internal and external (vendor) medical writing resources. Ensure consistency, accuracy, and compliance with global regulatory requirements and ICH guidelines. Manage document timelines, reviews, version control, and submission readiness. Collaborate with subject matter experts across R&D to capture key information and messaging. Translate complex scientific data into clear, structured content. Design and maintain templated documents on digital platforms for efficient updates and integration. Facilitate structured document reviews and resolve issues to meet deadlines. Qualifications: Bachelor’s or advanced degree in a life sciences discipline. 10+ years of medical or technical writing experience in the pharmaceutical or biotech industry. Proven experience with NDA, BLA, or MAA submissions. Strong understanding of regulatory and clinical development processes. Skilled in using digital collaboration tools (e.g., SharePoint). Excellent writing, editing, and communication skills. Ability to manage multiple projects and collaborate effectively across functions. Please apply directly if your experience aligns! Seniorities
Executive Employment type
Full-time Job function
Writing/Editing Industries Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Meet Life Sciences by 2x Inferred from the description for this job
Medical insurance Vision insurance Paid maternity leave 401(k) Paid paternity leave Get notified when a new job is posted. Sign in to set job alerts for “Medical Writer” roles.
Future Opportunities- Join Our Talent Pipeline for Principal Medical Writers (All Therapeutic Areas) in Medical Affairs
Chicago, IL $56,000.00-$84,000.00 6 days ago Chicago, IL $65,000.00-$75,000.00 1 week ago Scientific Content Developer, Technical Writer III
North Chicago, IL $52.00-$55.00 1 week ago Future Opportunities- Join Our Talent Pipeline for Principal Medical Writers (All Therapeutic)
Chicago, IL $60,000.00-$70,000.00 7 hours ago Evanston, IL $68,000.00-$75,000.00 2 weeks ago Streeterville, IL $65,520.00-$107,120.00 2 months ago In-House Clinical Research Associate (CRA)
Chicago, IL $60,000.00-$100,000.00 1 week ago Future Opportunities- Join Our Talent Pipeline for Medical Outcomes and Science Liaison (MOSL) (All Therapeutic Areas)
North Chicago, IL $35,000.00-$172,500.00 5 days ago Research Project Interviewer - Part Time
Decatur, IL $73,960.89-$192,277.06 3 months ago Arlington Heights, IL $17.00-$23.80 2 days ago In-house Clinical Research Associate (CRA)
Chicago, IL $60,000.00-$100,000.00 1 week ago Chicago, IL $50,000.00-$60,000.00 2 weeks ago Associate I, Clinical Pharmacology Scientific Support & Reporting
North Chicago, IL $64,000.00-$122,000.00 4 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr