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Senior Medical Writer
TransPerfect. Lead planning and preparation 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 document execution.
Highest-signal resume keywords
Medical Writing ExperienceClinical Study Report DevelopmentDocument Management Systems ExpertiseRegulatory Requirements KnowledgeProject Management Skills
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 ReportsProtocolsInvestigator BrochuresModule 2 DocumentsModule 5 DocumentsLean Authoring ApproachesStructured Content ManagementData InterpretationQuality Control ReviewLiterature Searches
Soft Skills
Strong Written CommunicationStrong Verbal CommunicationConflict ManagementNegotiation SkillsService-Oriented Approach
Tools & Technologies
Microsoft WordCollaborative Authoring ToolsDocument Management SystemsReview Tools
Industry Keywords
CROBiotechPharmaceuticalOncologyInfectious DiseaseVaccineICH Regulatory RequirementsUS Regulatory Requirements
About the role
Key responsibilities & impact- Lead planning and preparation of high-quality clinical regulatory documents
- Produce protocols, publications, study reports, investigator brochures, narratives, and module documents
- Lead document execution and project management tasks, including creating, maintaining, and communicating timelines
- Coordinate cross-functional 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 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 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
- Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents
- 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
- Conflict management and negotiation skills
- Strong written and verbal communication skills
- Oncology, Infectious Disease, or Vaccine experience desired
Benefits
Comp & perks- Equal employment opportunity regardless of race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by law