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Senior Regulatory Submissions Writer
Syneos Health. Lead the clear and accurate completion of 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 completion of clinical study protocols, reports, and regulatory submissions while adhering to ICH E3 guidelines and AMA Manual of Style. Proven ability to manage cross-departmental coordination and mentor junior writers in a biopharmaceutical or contract research organization environment.
Highest-signal resume keywords
Regulatory Writing ExperienceClinical Study ProtocolsICH E3 GuidelinesAMA Manual of StyleBiopharmaceutical Industry Knowledge
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 ReportsPatient NarrativesInvestigator BrochuresIND SubmissionsNDA SubmissionsECTD SubmissionsStatistical Analysis PlansDocument ReviewsTechnical SupportLiterature Searches
Soft Skills
Clear CommunicationMentoringProblem SolvingCollaborationAttention to Detail
Industry Keywords
FDA RegulationsEMA RegulationsGood Publication PracticesBiopharmaceutical IndustryContract Research Organization
About the role
Key responsibilities & impact- Lead the clear and accurate completion of medical writing deliverables
- Manage medical writing activities associated with individual studies
- Coordinate medical writing activities within and across departments
- Lead resolution of client comments
- Complete clinical study protocols, clinical study reports, patient narratives, investigator brochures, informed consents, plain language summaries, safety reports, IND submissions, NDA and eCTD submissions, manuscripts, abstracts, posters, and presentations
- Follow ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style guides
- Coordinate quality and editorial reviews
- Manage source documentation and lead team document reviews
- Act as peer reviewer for scientific content, clarity, consistency, and format
- Review statistical analysis plans and table/figure/listing specifications
- Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams
- 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, and capabilities
- Mentor and lead less experienced medical writers
- Develop expertise in industry topics and regulatory requirements
- Work within budgeted hours and communicate status and changes to medical writing leadership
- Complete administrative tasks and other assigned duties
Requirements
What you’ll need- 3-5 years of relevant experience in regulatory writing
- Experience working in the biopharmaceutical, device, or contract research organization industry
- Strong understanding of EMA, FDA and ICH regulations, other regulatory guidelines, and/or good publication practices
- Experience writing relevant document types
- Extensive knowledge of English grammar
- 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 and total rewards program
- Inclusive culture
- Company car or car allowance
- Medical, Dental and Vision health benefits
- Company match 401k
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO)
- Sick time