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Syneos HealthCore Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical writing, including the completion of clinical study protocols, reports, and regulatory submissions while adhering to ICH and FDA guidelines. Proven ability to manage writing activities, mentor junior writers, and collaborate effectively across departments.
Highest-signal resume keywords
Medical WritingRegulatory SubmissionsICH GuidelinesFDA RegulationsAMA Manual of Style
About the role
Key responsibilities & impact- Lead clear and accurate completion of medical writing deliverables
- Manage medical writing activities for individual studies with minimal supervision
- Coordinate medical writing activities within and across departments
- 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 presentations
- Follow ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides
- Coordinate quality and editorial reviews and manage source documentation
- Lead team document reviews and act as a peer reviewer
- Review statistical analysis plans and table/figure/listing specifications
- Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams
- Conduct online clinical literature searches and comply with copyright requirements
- Identify and resolve issues, escalating as appropriate
- Provide technical support, training, and consultation
- Contribute to internal materials, presentations, processes, standards, and capabilities
- Mentor and lead less experienced medical writers
- Develop expertise in industry topics and regulatory requirements
- Monitor assigned project budgets and communicate status and changes
- Complete required administrative tasks and other assigned duties
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
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices
- Experience writing relevant document types
- Extensive knowledge of English grammar and ability to communicate clearly
- Strong familiarity with AMA Manual of Style
- Ability to work within budgeted hours and communicate status and changes to medical writing leadership
- Equivalent experience, skills, and/or education will also be considered
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 may be required (less than 25%)
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Study ProtocolsClinical Study ReportsPatient NarrativesIND SubmissionsNDA SubmissionsStatistical Analysis PlansTechnical SupportDocument ReviewsQuality ControlLiterature Searches
Soft Skills
CommunicationMentoringCollaborationProblem-SolvingTime Management
Industry Keywords
BiopharmaceuticalContract Research OrganizationGood Publication PracticesSource DocumentationBudget Management