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Senior Medical Writer – Clinical Document Writing
Syneos Health. Lead clear and accurate completion of medical writing deliverables .
Posted 9/22/2026full-timeRemote • Missouri • United StatesSenior💰 $80,600 - $175,700 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical document writing, including protocols, clinical study reports, and investigator brochures, while adhering to ICH E3 guidelines and regulatory standards. Capable of managing medical writing activities, coordinating quality reviews, and mentoring less experienced writers.
Highest-signal resume keywords
Clinical Document WritingICH E3 GuidelinesQuality and Editorial ReviewsStatistical Analysis Plan ReviewTechnical Support and Training
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 ReportsInvestigator BrochuresRegulatory StandardsOnline Clinical Literature SearchesDocument ReviewBudget ManagementMedical Writing DeliverablesAuthoring RequirementsFormatting Guides
Soft Skills
MentoringCollaborationProblem SolvingCommunicationRelationship Building
Industry Keywords
Medical WritingClinical Development PlansIND SubmissionsNDA SubmissionsECTD SubmissionsPlain Language SummariesPeriodic Safety Update ReportsAbstractsPostersPresentations
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 and 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
- Adhere to 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 review documents as needed
- Act as peer reviewer for internal teams
- Review statistical analysis plans and table/figure/listing specifications
- Build working relationships 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, standard practices, and capabilities
- Mentor and lead less experienced medical writers on complex projects
- Develop expertise in industry topics and regulatory requirements
- Monitor project budgets and communicate status and changes to medical writing leadership
- Complete required administrative tasks
- Perform other assigned work-related duties
Requirements
What you’ll need- Clinical document writing experience with protocols, clinical study reports (CSRs), and investigator brochures (IBs)
- Ability to complete medical writing deliverables clearly and accurately
- Experience managing medical writing activities associated with individual studies
- Knowledge of ICH E3 guidelines and regulatory standards
- Knowledge of company SOPs, client standards, templates, authorship requirements, and style and formatting guides
- Experience coordinating quality and editorial reviews
- Ability to review statistical analysis plans and table/figure/listing specifications
- Experience performing online clinical literature searches and complying with copyright requirements
- Ability to provide technical support, training, and consultation
- Ability to mentor and lead less experienced medical writers on complex projects
- Deep expertise in industry topics and regulatory requirements and guidelines affecting medical writing
- Ability to work within budgeted hours and communicate status and changes
- Minimal travel may be required (less than 25%)
- 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 and total rewards program
- Inclusive culture
- 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) and sick time