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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 managing document timelines and facilitating cross-functional collaboration to achieve project goals.
Highest-signal resume keywords
Medical Writing ExperienceClinical Study Report DevelopmentDocument Management Systems ExpertiseRegulatory Requirements KnowledgeMicrosoft 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 ReportProtocol DevelopmentInvestigator BrochureModule 2 DocumentsModule 5 DocumentsLean Authoring ApproachesStructured Content ManagementLiterature SearchesPeer QC ReviewsConflict Management
Soft Skills
Excellent Communication SkillsProactive Project ManagementFlexibilityService-Oriented ApproachNegotiation Skills
Tools & Technologies
Document Management SystemsCollaborative Authoring ToolsReview ToolsMicrosoft Applications
Industry Keywords
CROBiotechPharmaceuticalOncologyInfectious DiseaseVaccineICH GuidelinesUS 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, 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 and related tools
- 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 document messaging, formatting, and presentation
- Conduct literature searches as needed
- Perform peer QC 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
- Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, Module 2, and Module 5 documents
- 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
- Flexibility to work across multiple therapeutic areas
- 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
- Oncology, Infectious Disease, or Vaccine experience desired
- Experience with client document management systems and related tools, templates, and procedures
- 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