Principal Medical Writer
About The Position
The Principal Medical Writer leads end-to-end development of complex regulatory clinical study documents, ensuring high-quality communication, scientific rigor, regulatory compliance, and timely delivery at global, regional, and local levels. Acting as the study medical writer within cross-functional teams, this role independently prepares or oversees clinical and regulatory documents, including protocols and clinical study reports for interventional and noninterventional studies through Phase 4. The role ensures alignment with business objectives, company standards, content organization, clarity, consistency, and appropriate English usage. The Principal Medical Writer represents Medical Writing as a subject-matter expert on clinical study teams, leads document-related meetings, and reviews study-related documents. The role also oversees external writers, mentors and develops fellow writers, and contributes to best practices and process improvements. The position is hybrid, requiring onsite work three days per week in Billerica, Massachusetts, and travel as needed.
Requirements
- Bachelor’s degree in a scientific or writing discipline.
- 5–8 years of relevant medical writing experience in pharma or biotech, with a strong regulatory documentation background.
- Experience leading and overseeing medical writing activities, including vendor resources, within a clinical trial.
- Experience leading and coordinating local and global teams in a matrix organization.
- Solid CTD or CTD-like knowledge.
- Solid knowledge of regulatory requirements, industry standards, and best practices related to medical writing.
- Excellent written and verbal English.
- Technical expertise in Microsoft Office and electronic document management tools.
- Ability to travel as needed.
Nice To Haves
- Master’s degree or PhD.
- Experience across multiple markets.
- Experience with country-specific submissions.
- Proficiency with document management systems, SharePoint, and standard medical writing templates.
- Experience with non-interventional study designs and device studies in development and post-approval settings.
- Familiarity with industry best practices, evolving regulatory guidelines, and everyday AI applications.
- Strong project management, communication, collaboration, and problem-solving skills.
- High attention to quality, accuracy, and compliance.
Responsibilities
- Lead medical writing efforts for global, regional, and local clinical study documents, including protocols, clinical study reports, and authority responses.
- Represent Medical Writing as a subject-matter expert on study teams and participate in governance and study team meetings.
- Lead document-related meetings and review study-related documents, such as statistical analysis plans.
- Define and implement document strategy and timelines.
- Oversee and coordinate external writers working on documents under the role’s responsibility, ensuring adherence to business objectives, company standards and SOPs, and regulatory and company requirements.
- Contribute proactively to the development and implementation of medical writing best practices and process improvements.
- Coordinate with clinical, pharmacovigilance, regulatory affairs, and statistics teams to ensure timely and compliant delivery.
- Mentor and develop fellow writers.
Benefits
- Health insurance.
- Paid time off (PTO).
- Retirement contributions.
- Other perquisites.
- Position may be eligible for sales or performance-based bonuses.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
