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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, including the development of clinical regulatory documents such as protocols, study reports, and investigator brochures, while ensuring compliance with ICH and US regulatory requirements. Proficient in project management and collaboration across cross-functional teams to deliver high-quality documentation within established timelines.
Highest-signal resume keywords
Medical Writing ExperienceClinical Regulatory Document DevelopmentMicrosoft Word ProficiencyKnowledge of ICH and US Regulatory RequirementsProject 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 Report WritingProtocol DevelopmentInvestigator Brochure CreationModule 2 Document PreparationModule 5 Document PreparationLean Authoring ApproachesStructured Content ManagementDocument Management SystemsCollaborative Authoring ToolsReview Tools
Soft Skills
Conflict ManagementNegotiation SkillsService-Oriented ApproachProactive Project ManagementStrong Communication Skills
Tools & Technologies
Document Management SystemsMicrosoft ApplicationsCollaborative Authoring Tools
Industry Keywords
CROBiotechPharmaceuticalOncologyInfectious DiseaseVaccine
About the role
Key responsibilities & impact- Partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management
- Lead the planning and preparation of high-quality clinical regulatory documents
- Produce protocols, publications, study reports, investigator brochures, narratives, and module documents according to client and agency guidelines
- 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, 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, including planning and leading 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 QC review as needed
- Contribute to medical writing operational initiatives such as templates, style guides, and reference management
Requirements
What you’ll need- Experience (5+ years) 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 desired in writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents
- Flexibility to work across multiple therapeutic areas, if needed
- Experience writing documents according to established processes and document templates
- Familiarity with lean authoring approaches and structured content management
- Familiarity with the requirements for preparation of key clinical and regulatory documents, including ICH and US regulatory requirements; working knowledge of ex-US regulatory requirements is desired
- Expertise with Microsoft Word and other Microsoft applications
- Experience developing documents using document management systems, collaborative authoring tools, and review tools
- Comfortable adapting to new tools and technologies, if needed
- Ability to work both independently and collaboratively in the face of competing priorities
- Service-oriented and proactive approach to project management
- Excellent conflict management and negotiation skills
- Comfortable providing suggestions based on previous experience
- Strong written and verbal communication skills
- Must be based in the US and legally authorized to work in the US