Principal Medical Writer

Merck•Billerica, MA

18d•Hybrid

About The Position

The Principal Medical Writer leads the end-to-end development of complex regulatory clinical study documents, ensuring scientific rigor, clear communication, 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 noninterventional and interventional studies through Phase 4. The position is accountable for alignment with business objectives, company standards, and regulatory requirements, as well as content organization, clarity, consistency, and appropriate English usage. The Principal Medical Writer represents Medical Writing as a subject-matter expert on study teams, leads document-related meetings, and reviews study-related documents. The role also coordinates internal and external writers, defines document strategies and timelines, contributes to best practices and process improvements, and mentors and develops fellow writers. The position is hybrid, requiring onsite work three days per week in Billerica, Massachusetts, with 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 skills.
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 strategies and timelines.
Oversee and coordinate external writers assisting with documents, ensuring adherence to business objectives, company standards, SOPs, and regulatory authority requirements.
Contribute 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.