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Senior Medical Writer – Regulatory Focus
Syneos Health. Lead clear and accurate medical writing deliverables and manage writing activities across departments .
Posted 9/23/2026full-timeRemote • United States, United Kingdom, CanadaSenior💰 $80,600 - $175,700 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in regulatory medical writing, including protocols, clinical study reports, and submissions, while effectively managing cross-departmental collaboration and project budgets. Proven ability to mentor junior writers and ensure compliance with ICH guidelines and company standards.
Highest-signal resume keywords
Lead Regulatory Writing ExperienceClinical Study Reports (CSRs)Protocols and SubmissionsProject Management SkillsClient 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
Medical Writing DeliverablesClinical Study ReportsProtocolsIND SubmissionsNDA SubmissionsICH E3 GuidelinesStatistical Analysis PlansSafety Aggregate ReportsIntegrated Summary Efficacy (ISE)Integrated Summary Safety (ISS)
Soft Skills
Project ManagementClient CollaborationTime ManagementMentoring
Industry Keywords
Clinical Development PlansInformed ConsentsPatient NarrativesInvestigator BrochuresPlain Language SummariesPeriodic Safety Update ReportsBriefing BooksECTD SubmissionsAuthors RequirementsCopyright Compliance
About the role
Key responsibilities & impact- Lead clear and accurate medical writing deliverables and manage writing activities across departments
- Lead resolution of client comments
- Complete 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
- Perform 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, standard practices, 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 to medical writing leadership
- Complete administrative tasks and other assigned duties
- Minimal travel may be required, less than 25%
Requirements
What you’ll need- Minimum of 5 years of lead regulatory writing experience
- Lead writing experience with Phase 2 and Phase 3 studies
- Lead writer experience with protocols
- Lead writer experience with submissions
- Lead writer experience with clinical Summary of Safety (CTD) Modules 2.7.3 and 2.7.4
- Lead writer experience with Clinical Study Reports (CSRs)
- Lead writer experience with Investigator Brochures (IBs)
- Lead writer experience with Patient Narratives
- Experience with Safety Aggregate Reports is a plus
- Lead writer experience with Briefing books
- Lead writer experience with Integrated Summary Efficacy (ISE) and Integrated Summary Safety (ISS)
- Strong project management skills
- Strong client experience
- Strong time management skills
- Process experience is a plus
- Open to candidates in the US, UK, and Canada
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