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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 and cross-functional collaboration to maintain timelines and document consistency.
Highest-signal resume keywords
Medical Writing ExperienceClinical Study Report WritingRegulatory Document ManagementProject Management SkillsMicrosoft Word Proficiency
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 Report WritingProtocol DevelopmentInvestigator Brochure CreationModule 2 Document PreparationModule 5 Document PreparationLean Authoring ApproachesStructured Content ManagementData InterpretationLiterature SearchesQuality Control Review
Soft Skills
Conflict ManagementNegotiation SkillsService-Oriented ApproachProactive Project ManagementExcellent Communication Skills
Tools & Technologies
Document Management SystemsCollaborative Authoring ToolsReview ToolsMicrosoft Applications
Industry Keywords
CROBiotechPharmaceuticalOncologyInfectious DiseaseVaccineICH Regulatory RequirementsUS Regulatory RequirementsEx-US 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, including creating, maintaining, and communicating timelines
- Coordinate cross-functional client contributors, stakeholders, and internal resources such as quality control and publishing
- Ensure documents follow 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 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 reviews 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 using 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
- Based in South Africa and legally authorized to work in South Africa
Benefits
Comp & perks- Full-time, permanent employment arrangement
- Remote work option
- Equal employment opportunity regardless of protected characteristics