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Senior Medical Writer – Regulatory Documents, CSR, Protocols, IB
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 and drug development, with a strong ability to produce regulatory documents and adhere to ICH E3 guidelines. Proven skills in mentoring, coordinating cross-functional teams, and managing project budgets while ensuring compliance with industry standards.
Highest-signal resume keywords
Medical Writing ExpertiseRegulatory Document PreparationICH E3 Guidelines KnowledgeStatistical Analysis Plan ReviewMentoring Medical Writers
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 SubmissionsECTD SubmissionsQuality and Editorial ReviewsOnline Clinical Literature SearchesTechnical SupportBudget Management
Soft Skills
Client Relationship BuildingCross-Functional CoordinationProblem SolvingCommunicationTeam Leadership
Industry Keywords
Regulatory StandardsSOPsAuthorship RequirementsStyle GuidesClinical Development PlansPeriodic Safety Update ReportsIntegrated Summary ReportsJournal ManuscriptsAbstractsPresentations
About the role
Key responsibilities & impact- Lead the clear and accurate completion of medical writing deliverables
- Manage medical writing activities for individual studies and coordinate across departments with minimal supervision
- 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 regulatory standards, company SOPs, client standards, approved templates, authorship requirements, and style 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
- Build working relationships with clients and cross-functional teams in data management, biostatistics, regulatory affairs, and medical affairs
- Perform online clinical literature searches
- Identify and propose solutions to 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
Requirements
What you’ll need- Experience and deep expertise in medical writing and drug development
- Ability to complete regulatory medical writing deliverables clearly and accurately
- Knowledge of ICH E3 guidelines and regulatory standards
- Ability to follow company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides
- Ability to coordinate quality and editorial reviews
- Ability to review statistical analysis plans and table/figure/listing specifications
- Ability to perform online clinical literature searches and comply with copyright requirements
- Ability to provide technical support, training, and consultation
- Ability to mentor and lead less experienced medical writers on complex projects
- 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
- 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
- Reasonable accommodations, when appropriate