Principal Medical Writer – Sponsor-dedicated

Syneos Health

. Lead the clear and accurate completion of complex medical writing deliverables .

Posted 10/9/2026full-timeRemote • Poland, France, Italy, Germany, Spain, United KingdomSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical writing, including the creation of clinical study documents and adherence to regulatory guidelines. Proven ability to lead cross-departmental collaboration and mentor junior writers while managing project timelines and budgets.

Highest-signal resume keywords

Medical WritingClinical Study ProtocolsFDA RegulationsICH GuidelinesAMA Manual of Style

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ReportsPatient NarrativesIND SubmissionsNDA SubmissionsStatistical Analysis PlansDocument StrategyData PresentationQuality ReviewsTechnical Subject Matter ExpertiseClinical Literature Searches

Soft Skills

Clear CommunicationMentoringCollaborationProblem SolvingClient Management

Industry Keywords

BiopharmaceuticalContract Research OrganizationGood Publication PracticesCross-Department CoordinationProject Budget Monitoring

About the role

Key responsibilities & impact

Lead the clear and accurate completion of complex medical writing deliverables
Manage medical writing activities for individual studies, including document strategy and cross-department coordination
Lead resolution of client comments
Write clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, safety reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations
Adhere to ICH E3 guidelines, company SOPs, client standards, templates, authorship requirements, and style guides
Advise clients and study teams on data presentation and production strategies
Lead document reviews and coordinate quality and editorial reviews
Serve as expert peer reviewer and review statistical analysis plans and table/figure/listing specifications
Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams
Perform clinical literature searches and comply with copyright requirements
Identify and resolve issues, serve as a technical SME, and contribute to internal materials and process improvements
Mentor and lead less experienced medical writers
Develop expertise in industry topics and regulatory requirements and engage with industry groups
Monitor project budgets, contribute to bid projections, negotiate timelines, and communicate status to leadership
Represent medical writing on study teams, at conferences, meetings, and client presentations
Complete administrative tasks and other assigned duties

Requirements

What you’ll need

At least 6 years of relevant experience in science, technical, or medical writing
Extensive experience working in the biopharmaceutical, device, or contract research organization industry
Advanced understanding of FDA and ICH regulations and guidelines and/or good publication practices
Extensive experience writing relevant document types
Extensive knowledge of English grammar and ability to communicate clearly
Strong familiarity with AMA Manual of Style
Minimal travel may be required (less than 25%)

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Inclusive culture