FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Senior Medical Writer
TransPerfect. Lead planning and preparation of high-quality clinical regulatory documents .
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 project management and cross-functional collaboration to facilitate document development and review processes.
Highest-signal resume keywords
Medical Writing ExperienceClinical Study Report WritingDocument Management Systems ExpertiseRegulatory Requirements KnowledgeProject 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 WritingModule 2 Document PreparationModule 5 Document PreparationLean Authoring ApproachesStructured Content ManagementData InterpretationLiterature SearchesQuality Control Reviews
Soft Skills
Conflict ManagementNegotiation SkillsProactive Project ManagementIndependent and Collaborative WorkFlexibility in Prioritization
Tools & Technologies
Microsoft WordCollaborative Authoring ToolsDocument Management SystemsReview Tools
Industry Keywords
CROBiotechPharmaceuticalOncologyInfectious DiseaseVaccineICH Regulatory RequirementsUS Regulatory RequirementsEx-US 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 project management tasks and timeline communication
- Coordinate cross-functional client contributors, stakeholders, and internal resources such as quality control and publishing
- Ensure document development follows client processes, templates, and instructions
- 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 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
- Perform peer quality-control reviews
- Contribute to medical writing operational initiatives such as templates, style guides, and reference management
- Partner cross-functionally with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management teams
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 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
- Comfort 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
- Strong written and verbal communication skills in English
- Based in Spain and legally authorized to work in Spain
Benefits
Comp & perks- Full-time, permanent employment
- Equal employment opportunity regardless of protected characteristics