Senior Medical Writer

TGS

. Lead planning and preparation of high-quality clinical regulatory documents .

Posted 9/30/2026full-timeRemote • SpainSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical writing, including the production 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 to deliver high-quality documentation in the CRO/biotech/pharmaceutical field.

Highest-signal resume keywords

Medical Writing ExperienceClinical Regulatory DocumentsDocument Management SystemsProject ManagementICH Regulatory Requirements

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ReportsProtocolsInvestigator BrochuresModule 2 DocumentsModule 5 DocumentsLean Authoring ApproachesStructured Content ManagementData InterpretationQuality Control ReviewsLiterature Searches

Soft Skills

Strong Written CommunicationStrong Verbal CommunicationConflict ManagementNegotiation SkillsService-Oriented Approach

Tools & Technologies

Microsoft WordCollaborative Authoring ToolsDocument Management SystemsReview Tools

Industry Keywords

CROBiotechPharmaceuticalOncologyInfectious DiseaseVaccineRegulatory 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 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 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 quality-control 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 ICH and US regulatory requirements; working knowledge of ex-US regulatory requirements desired
Expertise with Microsoft Word and other Microsoft applications
Experience using document management systems, collaborative authoring tools, and review tools
Strong written and verbal communication skills in English
Ability to work independently and collaboratively amid competing priorities
Service-oriented and proactive project management approach
Conflict management and negotiation skills
Ability to adapt to new tools and technologies

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