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Senior Medical Writer – Regulatory Submission Documents
Syneos Health. Partner closely with Clinical Scientists, focusing on protocols and protocol amendments .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical writing, including protocol writing and regulatory submissions, while adhering to ICH E3 guidelines and FDA regulations. Proven ability to manage multiple projects, mentor junior writers, and collaborate effectively with cross-functional teams.
Highest-signal resume keywords
Medical WritingProtocol WritingRegulatory SubmissionsFDA RegulationsVeeva/CARA Experience
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 PlansDocument ReviewsTechnical SupportQuality ReviewsOncology/Hematology Writing
Soft Skills
Clear CommunicationMentoringProblem SolvingCollaborationClient Relationship Building
Tools & Technologies
VeevaCARA
Industry Keywords
BiopharmaceuticalContract Research OrganizationLate DevelopmentICH GuidelinesAMA Manual of Style
About the role
Key responsibilities & impact- Partner closely with Clinical Scientists, focusing on protocols and protocol amendments
- 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 scientific meeting presentations
- Adhere to ICH E3 guidelines, regulatory standards, SOPs, client standards, approved templates, authorship requirements, and style and formatting guides
- Coordinate quality and editorial reviews
- Manage source documentation appropriately
- Lead team document reviews and review documents as needed
- Act as peer reviewer for scientific content, clarity, consistency, and format
- Review statistical analysis plans and table/figure/listing specifications
- Provide feedback defining statistical outputs and document needs
- Build working 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 and propose solutions, escalating issues as appropriate
- Provide technical support, training, and consultation
- Contribute to internal materials, presentations, processes, standards, practices, and capabilities
- Mentor and lead less experienced medical writers on complex projects
- Develop expertise in industry topics and regulatory requirements affecting medical writing
- Monitor project budgets and communicate status or changes to medical writing leadership
- Complete required administrative tasks
- Perform other assigned work-related duties
Requirements
What you’ll need- 3-5 years of relevant experience in medical writing
- Proven experience in protocol writing
- Experience in the biopharmaceutical, device, or contract research organization industry
- Experience with late development
- Experience with Oncology/Hematology/Cell therapy
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices
- Experience writing relevant document types
- Experience working with Veeva/CARA
- Extensive knowledge of English grammar
- Ability to communicate clearly
- Strong familiarity with AMA Manual of Style
- Ability to work within budgeted hours and communicate status and changes
- 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
- Inclusive work culture
- Company car or car allowance
- Medical, Dental and Vision health benefits
- Company match 401k
- Employee Stock Purchase Plan eligibility
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO)
- Sick time
- Remote work arrangement