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Senior Medical Writer
TransPerfect. Lead planning, preparation, and execution of high-quality clinical regulatory documents .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in producing high-quality clinical regulatory documents, including protocols and study reports, while ensuring compliance with ICH and US regulatory requirements. Proficient in project management, document management systems, and collaborative authoring tools to facilitate effective communication and coordination across cross-functional teams.
Highest-signal resume keywords
Medical Writing ExperienceClinical Study Report DevelopmentRegulatory Document ManagementMicrosoft Word ProficiencyICH Regulatory 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 ReportProtocol DevelopmentInvestigator BrochureModule 2 DocumentsModule 5 DocumentsLean Authoring ApproachesStructured Content ManagementDocument TemplatesData InterpretationQuality Control Review
Soft Skills
Conflict ManagementNegotiation SkillsService-Oriented ApproachProactive Project ManagementCollaboration
Tools & Technologies
Document Management SystemsCollaborative Authoring ToolsReview ToolsMicrosoft Applications
Industry Keywords
CROBiotechPharmaceuticalOncologyInfectious DiseaseVaccineUS Regulatory RequirementsEx-US Regulatory Requirements
About the role
Key responsibilities & impact- Lead planning, preparation, and execution of high-quality clinical regulatory documents
- Partner cross-functionally with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management client teams
- Produce protocols, publications, study reports, investigator brochures, narratives, and module documents
- Create, maintain, and communicate project timelines
- Coordinate client contributors, stakeholders, and internal resources such as quality control and publishing
- Ensure document development follows client processes, templates, and instructional documents
- Serve as an expert on client document management systems, tools, templates, and procedures
- Lead document message development with clients
- Interpret data and create shell documents
- Plan and lead kickoff meetings
- Facilitate review feedback and lead comment resolution meetings
- Resolve outstanding review feedback with individual team members
- Ensure consistency in messaging, formatting, and presentation across client programs
- Conduct literature searches as needed
- Perform peer quality-control review as needed
- Contribute to medical writing operational initiatives such as templates, style guides, and reference management
Requirements
What you’ll need- 5+ years of experience as a medical writer in the CRO/biotech/pharmaceutical field
- Bachelor’s degree or higher in a relevant field
- Oncology, Infectious Disease, or Vaccine experience desired
- Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents desired
- Flexibility to work across multiple therapeutic areas
- Experience writing documents according to established processes and document templates
- Familiarity with lean authoring approaches and structured content management
- Familiarity with ICH and US regulatory requirements; working knowledge of ex-US regulatory requirements desired
- Expertise with Microsoft Word and other Microsoft applications
- Experience with document management systems, collaborative authoring tools, and review tools
- Ability to adapt to new tools and technologies
- Ability to work independently and collaboratively amid competing priorities
- Service-oriented and proactive approach to project management
- Excellent conflict management and negotiation skills
- Strong written and verbal communication skills
- Must be based in the US and legally authorized to work in the US
Benefits
Comp & perks- Fully remote work in the US
- Equal employment opportunity regardless of protected characteristics