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Senior Medical Writer
TransPerfect. Partner cross-functionally with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management client teams .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical writing, including the production of clinical regulatory documents such as protocols and study reports, while ensuring compliance with ICH and US regulatory requirements. Proficient in project management and collaboration across cross-functional teams to deliver high-quality documentation in the pharmaceutical and biotech sectors.
Highest-signal resume keywords
Medical Writing ExperienceClinical Regulatory Document ProductionProject Management SkillsKnowledge of ICH and US Regulatory RequirementsExpertise with Document Management Systems
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Study Report WritingProtocol DevelopmentInvestigator Brochure CreationModule 2 and Module 5 Document WritingLean Authoring ApproachesStructured Content ManagementData InterpretationQuality Control ReviewLiterature Search ConductingConflict Management
Soft Skills
Excellent Communication SkillsProactive Project ManagementService-Oriented ApproachFlexibility in Working Across Therapeutic AreasNegotiation Skills
Tools & Technologies
Microsoft WordCollaborative Authoring ToolsDocument Management SystemsReview ToolsQuality Control Tools
Industry Keywords
CROBiotechPharmaceuticalOncologyInfectious DiseaseVaccinesRegulatory ComplianceClinical DevelopmentClinical OperationsBiostatistics
About the role
Key responsibilities & impact- Partner cross-functionally with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management client teams
- Lead planning and preparation of high-quality clinical regulatory documents supporting drug development
- Produce protocols, publications, study reports, investigator brochures, narratives, and module documents according to client and agency guidelines
- Lead document execution and project management tasks, including creating, maintaining, and communicating 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 and related tools, templates, and procedures
- Lead document message development with clients
- Interpret data and create shell documents to support authoring
- Plan and lead kickoff meetings
- Facilitate review feedback resolution and lead comment resolution meetings
- Follow up with team members to resolve outstanding review feedback
- Ensure consistency across client programs in messaging, formatting, and document presentation
- 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
- Experience in oncology, infectious disease, or vaccines 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
- Comfortable adapting 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