Senior Medical Writer, Regulatory Affairs

Role Summary

Senior Medical Writer responsible for leadership in development and execution of regulatory document deliverables to support clinical trial applications, Health Authority interactions, and filings. Applies scientific writing principles, collaborates cross-functionally, and ensures compliance with global regulatory expectations. Oncology experience preferred. Role may be remote or onsite.

Responsibilities

• Independently author complex documents compliant with internal processes, standards, and external regulatory guidance.
• Collaborate cross-functionally with subject matter experts to present analyses clearly and concisely in assigned documents.
• Plan and review tables, listings, and figures for assigned documents with project teams and experts.
• Co-author documents for clinical trials including protocols, investigator brochures, clinical study reports, clinical summaries for marketing applications, and responses to regulatory authority queries.
• Provide guidance on document development for regulatory writing deliverables, including organization, content, and resource requirements.
• Collaborate with CMC, non-clinical SMEs on generation of relevant sections for INDs/CTAs, DMFs, briefing documents, technical reports, and related materials.
• Work with Project Management and Regulatory Affairs to establish timelines and contingencies for timely delivery.
• Perform internal document reviews, editing, and QC as needed.

Qualifications

• PhD, PharmD, or MD with 4+ years of experience; 6+ years with Master’s; 8+ years with BS/BA in a relevant field with 2 years of direct regulatory/clinical writing experience.
• Ability to collaborate effectively with all levels in cross-functional, global teams.
• Experience independently authoring CSRs, protocols, and submission documents (e.g., IND components, NDA components).
• Strong organizational skills with ability to prioritize multiple projects and timelines.
• Analytical ability to interpret complex clinical and scientific data and present it clearly.
• Excellent interpersonal skills, active listening, and ability to influence and build professional relationships.
• Knowledge of public databases (PubMed, DailyMed, FDA, EMA) for literature mining and citation practices.
• Ability to consolidate and summarize data from multiple sources; strong written communication to diverse audiences.
• Proficiency in Microsoft Word; other software (PowerPoint, Excel, Adobe Acrobat); Veeva RIM experience preferred.
• Attention to detail; experience with quality control and editing of scientific documents.

Skills

• Regulatory writing
• Cross-functional collaboration
• Scientific data interpretation
• Documentation planning and management
• Quality control and editing
• Literature research and citation
• Software proficiency: Word, PowerPoint, Excel, Adobe Acrobat; Veeva RIM (preferred)

Education

• PhD, PharmD, or MD (required per years of experience) or Master’s/BS/BA with relevant regulatory/clinical writing experience