T
Senior Medical Writer
Not specifiedFull-timeTechnical Writing And TrainingBiopharmaceuticals
Develop and lead clinical regulatory document preparation for drug development and product registrations. Write and edit submission documents, coordinate contributors, and ensure clear, accurate, compliant scientific content.
Responsibilities
- Write and edit protocols, clinical study reports, investigator brochures, briefing books, health authority responses, and regulatory submission documents
- Compile, analyze, and summarize information from multiple sources
- Proofread, format documents, and resolve comments
- Ensure documents are accurate, complete, consistent, and aligned with regulatory guidance and editorial standards
- Lead document development, including project kickoff and comment resolution meetings
- Coordinate with cross-functional stakeholders and manage timelines, progress, and competing priorities
- Provide guidance and training to medical writers and external contributors
- Contribute to templates, standard operating procedures, process improvements, budgets, and annual operational planning
Requirements
- Bachelor's degree in life sciences or a related field; advanced degree preferred
- At least eight years of relevant experience
- Lead-author proficiency with protocols and amendments, clinical study reports, investigator brochures, and clinical summary documents
- Strong knowledge of global submission regulations and authoring guidelines
- Excellent written and spoken English
- Proficiency with Microsoft Word; familiarity with Veeva Vault or similar document systems
- Knowledge of drug development, therapeutic areas, and statistical concepts
Nice to have
- Advanced degree such as a master's, MD, PhD, or PharmD
- At least eight years of relevant experience with an advanced degree
Benefits
- Flexible work-life balance
- Inclusive, collaborative culture
- Opportunities for professional growth