Senior Medical Writer
BioMarin Pharmaceutical Inc.
August 31, 2026
Remote friendly (United States)
United States
$142,100 - $195,360 USD yearly
Clinical Research and Development
Responsibilities:
- Draft and edit clinical study documents: protocols, protocol amendments, informed consent forms, and clinical study reports.
- Draft and edit aggregate safety/efficacy documents: investigator’s brochures and periodic safety reports (e.g., PBRERs, DSURs).
- Draft and edit regulatory filing documents (e.g., briefing books; eCTD Module 2/Module 5 clinical or integrated summaries).
- Manage document timelines/review processes; run meetings with study teams and oversee comment adjudication.
- Represent Global Medical Writing at cross-functional meetings.
- Provide peer review/editing for regulatory documents (e.g., statistical analysis plans, CRFs, other study materials).
- Develop/review standard processes and templates within Global Medical Writing (and advise other departments as needed).
- Follow departmental procedures and technical/industry standards; work effectively cross-functionally.
Qualifications/Experience:
- Up to 6 years medical writing in pharma OR at least 10 years medical/scientific writing as a primary responsibility.
- Experience writing/reviewing/editing protocols and clinical study reports (required).
- Experience with INDs/NDAs and safety reports (highly preferred): INDs, BLA/NDAs, PBRERs, DSURs, PAERs; briefing books (preferred).
Skills/Tools:
- Advanced knowledge of document preparation (style guides, medical dictionaries, guidance documents) and ability to create complex clinical tables/figures.
- Working knowledge of coding dictionaries (MedDRA, WHO Drug) and clinical lab tests.
- Intermediate-to-advanced drug development and clinical study/data concepts.
- Intermediate-to-advanced regulatory knowledge; familiarity with eCTD IND/NDA work (ISS/ISE).
- Strong project management, conflict management, and communication skills.
- Bachelor’s degree required (scientific focus desirable).
- Proficient: MS Word, Excel, Adobe Acrobat, MS Project/Project Server, PowerPoint; document management software (e.g., LiveLink/SharePoint/Veeva).
- Education/certification: AMA/Editor in Life Sciences/DIA training desirable.
- Draft and edit clinical study documents: protocols, protocol amendments, informed consent forms, and clinical study reports.
- Draft and edit aggregate safety/efficacy documents: investigator’s brochures and periodic safety reports (e.g., PBRERs, DSURs).
- Draft and edit regulatory filing documents (e.g., briefing books; eCTD Module 2/Module 5 clinical or integrated summaries).
- Manage document timelines/review processes; run meetings with study teams and oversee comment adjudication.
- Represent Global Medical Writing at cross-functional meetings.
- Provide peer review/editing for regulatory documents (e.g., statistical analysis plans, CRFs, other study materials).
- Develop/review standard processes and templates within Global Medical Writing (and advise other departments as needed).
- Follow departmental procedures and technical/industry standards; work effectively cross-functionally.
Qualifications/Experience:
- Up to 6 years medical writing in pharma OR at least 10 years medical/scientific writing as a primary responsibility.
- Experience writing/reviewing/editing protocols and clinical study reports (required).
- Experience with INDs/NDAs and safety reports (highly preferred): INDs, BLA/NDAs, PBRERs, DSURs, PAERs; briefing books (preferred).
Skills/Tools:
- Advanced knowledge of document preparation (style guides, medical dictionaries, guidance documents) and ability to create complex clinical tables/figures.
- Working knowledge of coding dictionaries (MedDRA, WHO Drug) and clinical lab tests.
- Intermediate-to-advanced drug development and clinical study/data concepts.
- Intermediate-to-advanced regulatory knowledge; familiarity with eCTD IND/NDA work (ISS/ISE).
- Strong project management, conflict management, and communication skills.
- Bachelor’s degree required (scientific focus desirable).
- Proficient: MS Word, Excel, Adobe Acrobat, MS Project/Project Server, PowerPoint; document management software (e.g., LiveLink/SharePoint/Veeva).
- Education/certification: AMA/Editor in Life Sciences/DIA training desirable.