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Principal Medical Writer
Syneos Health. Lead clear and accurate completion of complex medical writing deliverables .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical writing, including the development of clinical and regulatory documents, manuscripts, and presentations, while adhering to industry guidelines and standards. Proven ability to lead publication planning and execution, mentor teams, and manage cross-functional collaborations effectively.
Highest-signal resume keywords
Advanced Degree In Scientific DisciplineMedical Writing ExperiencePublication Planning And ExecutionAI Tools UtilizationICH E3 Guidelines Adherence
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Document DevelopmentRegulatory Document PreparationStatistical Analysis Plan ReviewContent DevelopmentPublication StrategyManuscript WritingAbstract WritingPresentation DevelopmentQuality Review CoordinationTechnical Subject Matter Expertise
Soft Skills
Team LeadershipClient Relationship ManagementMentoringCommunicationProblem Solving
Tools & Technologies
AI ToolsData Management SystemsBiostatistics SoftwareMedical Affairs Platforms
Industry Keywords
Pharmaceutical IndustryBiotechnologyMedical CommunicationsConsultingICH Guidelines
About the role
Key responsibilities & impact- Lead clear and accurate completion of complex medical writing deliverables
- Manage medical writing activities for individual studies, define document strategy, and coordinate activities across departments
- Complete clinical and regulatory documents, manuscripts, abstracts, posters, and presentations
- Advise clients and study teams on data presentation and production strategies
- Lead team document reviews and coordinate quality and editorial reviews
- Serve as an expert peer reviewer for internal teams
- Review statistical analysis plans and table, figure, and listing specifications
- Build relationships with clients and cross-functional teams in data management, biostatistics, regulatory affairs, and medical affairs
- Perform online clinical literature searches and comply with copyright requirements
- Identify solutions, serve as a technical subject matter expert, 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, and communicate status and timeline changes
- Represent medical writing on clinical study teams, at conferences, meetings, and client presentations
- Complete administrative tasks and other assigned duties
Requirements
What you’ll need- Advanced degree in a scientific discipline required (MS, PhD, PharmD, MD, or equivalent)
- PhD or PharmD strongly preferred
- Minimum 5 years of relevant experience within the pharmaceutical, biotechnology, medical communications, or consulting industries
- Demonstrated experience leading publication planning, publication strategy, and publication execution programs
- Proven track record developing and executing integrated publication plans across multiple studies and assets
- Strong hands-on scientific writing and content development experience, including manuscripts, congress abstracts, posters, and presentations
- Experience utilizing AI tools and technologies to support publication development
- Preferred location: U.S. East Coast
- Ability to adhere to ICH E3 guidelines, company standard operating procedures, client standards, approved templates, authorship requirements, and style and formatting guides
- 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 and total rewards program
- Company car or car allowance
- Medical, Dental and Vision health benefits
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO)
- Sick time
- Reasonable accommodations, when appropriate