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Senior Medical Writer
TransPerfect. Partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management .
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 and study reports, while ensuring compliance with ICH and US regulatory requirements. Proficient in project management and collaboration across cross-functional teams in the CRO/biotech/pharmaceutical sectors.
Highest-signal resume keywords
Medical Writing ExperienceClinical Regulatory Document DevelopmentProject Management SkillsKnowledge of ICH and US Regulatory RequirementsExpertise in Microsoft Word
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Study Report WritingProtocol DevelopmentInvestigator Brochure CreationModule 2 and Module 5 Document WritingLean Authoring ApproachesStructured Content ManagementData InterpretationQuality Control ReviewLiterature Search ConductingDocument Management Systems
Soft Skills
Excellent Communication SkillsConflict ManagementNegotiation SkillsService-Oriented ApproachProactive Project Management
Tools & Technologies
Microsoft ApplicationsCollaborative Authoring ToolsReview ToolsDocument Management Systems
Industry Keywords
CROBiotechPharmaceuticalOncologyInfectious DiseaseVaccineRegulatory ComplianceClinical DevelopmentClinical OperationsBiostatistics
About the role
Key responsibilities & impact- Partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management
- 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 tasks, including creating, maintaining, and communicating timelines
- Coordinate 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
- Plan and lead kickoff meetings
- Facilitate review feedback and lead 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 review 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 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 with competing priorities
- Service-oriented and proactive approach to project management
- Excellent conflict management and negotiation skills
- Strong written and verbal communication skills in English
- Applicants must be based in Spain and legally authorized to work in Spain
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 state, federal, or local law