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Principal Medical Writer – Regulatory Medical Writing
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 extensive expertise in Regulatory Medical Writing, including authoring complex documents such as Protocols, Clinical Study Reports, and IND submissions. Proven ability to lead document strategy, mentor junior writers, and ensure compliance with regulatory standards and company SOPs.
Highest-signal resume keywords
Regulatory Medical WritingLead Medical Writer ExperienceDocument Development ManagementKnowledge of ICH E3 GuidelinesMedical Writing Subject Matter Expertise
ATS Keywords
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Hard Skills
Authoring ProtocolsClinical Study ReportsPatient NarrativesStatistical Analysis PlansDocument Strategy DefinitionQuality and Editorial ReviewsOnline Clinical Literature SearchesData Presentation StrategiesIND SubmissionsNDA Submissions
Soft Skills
Client Relationship BuildingMentoring Less Experienced WritersProblem SolvingCommunicationNegotiation
Industry Keywords
Regulatory StandardsCRO EnvironmentPharmaceutical CompaniesSOPsAuthorship RequirementsFormatting GuidesClinical Development PlansPeriodic Safety Update ReportsIntegrated Summary ReportsScientific Meeting Presentations
About the role
Key responsibilities & impact- Lead 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
- Complete clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and scientific meeting presentations
- Apply regulatory standards, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides
- Advise clients and study teams on data presentation and production strategies
- Lead document reviews and coordinate quality and editorial reviews
- Serve as an expert peer reviewer for the internal team
- Review statistical analysis plans and table/figure/listing specifications
- Build relationships with clients and teams in data management, biostatistics, regulatory affairs, and medical affairs
- Perform online clinical literature searches
- Propose solutions and serve as a technical subject matter expert
- Contribute to internal materials, presentations, processes, standard practices, and capabilities
- Mentor and lead less experienced medical writers
- Develop expertise in industry topics and regulatory requirements
- Engage externally with industry groups
- Monitor project budgets and contribute to bid projections
- Communicate status and changes to medical writing leadership
- Negotiate timelines and assigned deliverables
- Represent medical writing on clinical study teams, at conferences, meetings, and client presentations
- Complete required administrative tasks
- Perform other assigned duties
Requirements
What you’ll need- 5+ years of Regulatory Medical Writing experience
- Expertise in authoring Protocols, Protocol Amendments, CSRs, Narratives, PSURs, DSURs, ICFs, and IBs
- Proven Lead Medical Writer experience
- Experience independently managing end-to-end document development in a CRO environment
- Experience partnering with pharmaceutical companies
- Ability to author complex medical writing deliverables clearly and accurately
- Ability to define document strategy and coordinate medical writing activities with minimal supervision
- Knowledge of regulatory standards, including ICH E3 guidelines
- Ability to follow company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides
- Ability to advise clients and study teams on data presentation and production strategies
- Experience leading team document reviews and reviewing documents for technical issues
- Ability to coordinate quality and editorial reviews and manage source documentation
- Ability to review statistical analysis plans and table/figure/listing specifications
- Ability to perform online clinical literature searches and comply with copyright requirements
- Ability to identify and resolve issues, escalating as appropriate
- Medical writing subject matter expertise
- Ability to mentor and lead less experienced medical writers
- Knowledge of industry topics and regulatory requirements and guidelines affecting medical writing
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Minimal travel (less than 25%)