Senior Medical Writer Opportunity in Spain with TransPerfect

Further Details

This Senior Medical Writer position within TransPerfect's operations in Catalunya, Spain, is ideal for experienced professionals in the CRO, biotech, or pharmaceutical sectors. The role requires a Bachelor's degree or higher, with a focus on clinical regulatory document preparation and project management for drug development initiatives. The ideal candidate will possess strong analytical skills and a proven ability to manage cross-functional teams.

Senior Medical Writer | Spain

TransPerfect is actively seeking a skilled Senior Medical Writer to enhance their medical writing team based in Catalunya, Spain. This vital role involves collaborating with client teams to lead the planning and generation of essential clinical regulatory documents, crucial for advancing drug development projects within aggressive timeframes.

As a Senior Medical Writer, you will be instrumental in ensuring the quality and compliance of all documentation, working cross-functionally with departments such as Clinical Development, Biostatistics, and Regulatory Affairs. Your expertise will guide the creation of protocols, publications, study reports, and more, adhering strictly to client and agency standards.

• Industry: Pharmaceutical / Biotechnology
• Location: Catalunya, Spain
• Experience Required: 5+ Years
• Qualifications: Bachelor's Degree or higher
• Key Skills: Clinical Document Writing, Project Management, Cross-functional Collaboration, Regulatory Compliance

Explore these latest recruitment with competitive benefits.

Skills

• Bachelor’s degree or higher in a relevant field
• 5+ years of experience as a medical writer
• Experience in the CRO/biotech/pharmaceutical field
• Oncology, Infectious Disease, or Vaccine experience desired
• Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents
• 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 the requirements for preparation of 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 both independently and collaboratively
• 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

Duties and Responsibilities:

• Lead the execution of documents, including project management tasks such as creating, maintaining, and communicating timelines
• Coordinate cross-functional client contributors and stakeholders as well as internal resources (e.g., quality control [QC], publishing) to ensure timely completion of documents
• Ensure document development adheres to any relevant client processes, templates, and instructional documents
• Serve as an expert on client document management system and related tools, templates, and procedures to ensure efficient document development
• Lead document message development in collaboration with client
• Interpret data and create shell documents to support authoring
• Plan and lead kickoff meetings
• Facilitate resolution of review feedback including planning and leading comment resolution meetings
• Follow-up with individual team members as needed to resolve outstanding review feedback
• Ensure consistency among client programs in terms of messaging, formatting, and presentation of documents
• Conduct literature searches as needed
• Perform peer QC review as needed
• Contribute to medical writing operational initiatives (e.g., templates, style guides, reference management), if needed

How to apply

• Review Application Deadline: Ensure your application is submitted before the closing date of 18 December 2026.
• Visit Application Portal: Navigate to the official application link provided by Eurojobs to access the application form.
• Prepare Your Documents: Have your updated CV, relevant certifications, and any other required supporting documents ready for submission.
• Submit Application: Complete the online application form accurately and upload all necessary documents.
• Confirmation: Look out for a confirmation email acknowledging the receipt of your application.