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Senior Medical Writer
TransPerfect. Lead execution of clinical regulatory documents and related project management tasks, including creating, maintaining, and communicating timelines .
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, with a strong focus on clinical study reports, protocols, and compliance with ICH and US regulatory requirements. Proficient in project management and cross-functional collaboration, ensuring consistency and quality in document development across therapeutic areas.
Highest-signal resume keywords
Medical Writing ExperienceClinical Regulatory DocumentsProject ManagementMicrosoft Word ExpertiseOncology Experience
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 ManagementDocument Management SystemsCollaborative Authoring Tools
Soft Skills
Conflict ManagementNegotiation SkillsService-Oriented ApproachProactive Project ManagementStrong Communication Skills
Tools & Technologies
Microsoft ApplicationsDocument Management SystemsReview Tools
Industry Keywords
CROBiotechPharmaceuticalOncologyInfectious DiseaseVaccineICH Regulatory RequirementsUS Regulatory RequirementsEx-US Regulatory Requirements
About the role
Key responsibilities & impact- Lead execution of clinical regulatory documents and related 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, including planning and leading 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 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
- 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 requirements for key clinical and regulatory documents, including ICH and US regulatory requirements
- Working knowledge of ex-US regulatory requirements 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
- Ability to work independently and collaboratively amid 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 in English
- Must be based in the UK and legally authorized to work in the UK
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
- Permanent, fixed-term, and freelance/contractor employment arrangements are available
- Onsite, hybrid, and remote work models are available for London or Manchester