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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical writing and regulatory document management within the CRO/biotech/pharmaceutical sectors, with a strong focus on oncology, infectious disease, and vaccines. Proficient in project management, cross-functional collaboration, and adherence to regulatory requirements.
Highest-signal resume keywords
Medical Writing ExperienceClinical Regulatory DocumentsDocument Management SystemsMicrosoft 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 ReportsProtocolsProtocol AmendmentsInvestigator BrochuresModule 2 DocumentsModule 5 DocumentsLean Authoring ApproachesStructured Content ManagementData InterpretationLiterature Searches
Soft Skills
Project ManagementConflict ManagementNegotiation SkillsStrong Written CommunicationStrong Verbal Communication
Tools & Technologies
Document Management SystemsCollaborative Authoring ToolsReview ToolsMicrosoft Applications
Industry Keywords
CROBiotechPharmaceuticalOncologyInfectious DiseaseVaccinesUS Regulatory RequirementsEx-US Regulatory Requirements
About the role
Key responsibilities & impact- Lead execution of clinical regulatory documents and related project management tasks
- Create, maintain, and communicate project 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 for 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 document presentation across client programs
- 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 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
- 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 in English
- Based in the UK and legally authorized to work in the UK
Benefits
Comp & perks- Full-time, permanent employment
- Remote work option
- Equal employment opportunity