Principal Medical Writer – Publications

Syneos Health

Principal Medical Writer at Syneos Health overseeing the completion of medical writing deliverables. Role involves collaboration with clients and adherence to regulatory standards in biopharmaceutical context.

Posted 5/8/2026full-timeRemote • Arizona, Maine, Ohio, Rhode Island • 🇺🇸 United StatesLeadWebsite

About the role

Key responsibilities & impact

Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately
Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision
Completes a variety of documents that may include clinical study protocols, clinical study reports, patient narratives, annual reports, investigator brochures, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts
Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures
Coordinates quality and editorial reviews
Ensures source documentation is managed appropriately
Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format
Provides feedback to further define statistical output required and document needs
Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs as necessary
Performs online clinical literature searches and complies with copyright requirements
Identifies and proposes solutions to resolve issues, escalating as appropriate
Provides technical support, training, and consultation to department and other company staff
Mentors and leads less experienced medical writers on complex projects, as necessary

Requirements

What you’ll need

3-5 years of relevant experience in science, technical, or medical writing
Experience working in the biopharmaceutical, device, or contract research organization industry required
Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
Experience writing relevant document types required
Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style

Benefits

Comp & perks

We are passionate about developing our people, through career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition and total rewards program
Inclusive culture – where you can authentically be yourself
Learning opportunities and resources

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

medical writingclinical study protocolsclinical study reportspatient narrativesannual reportsinvestigator brochuresperiodic safety update reportsIND submissionsNDA submissionseCTD submissions

Soft Skills

communicationcoordinationpeer reviewmentoringproblem-solvingfeedback provisionrelationship buildingtechnical supporttrainingconsultation