Senior Medical Writer - Clinical Regulatory Documents in Spain

Further Details

TransPerfect, a leading organization in the life sciences sector, is recruiting for a Senior Medical Writer based in Catalonia, Spain. This position demands a proactive individual to lead the planning and preparation of essential clinical regulatory documents, working hand-in-hand with client teams. The role requires a strong understanding of drug development processes and the ability to manage project timelines efficiently, supporting the creation of vital documents like protocols and study reports. Ideal candidates will possess substantial experience in the CRO/biotech/pharmaceutical field, with a Bachelor’s degree or higher. Experience in Oncology, Infectious Disease, or Vaccine areas is a significant advantage. This role provides a fantastic opportunity to contribute to global health initiatives and advance your career in medical writing within a dynamic and supportive environment.

Senior Medical Writer - Leading Pharmaceutical Opportunities in Spain

JR Spain, in partnership with TransPerfect, is announcing exciting career prospects for a Senior Medical Writer in Catalonia, Spain. This role is integral to drug development, focusing on the meticulous planning and preparation of high-quality clinical regulatory documents. Key Position Highlights:

• Lead the production of essential documents such as protocols, publications, and study reports.
• Collaborate with cross-functional client teams, including Clinical Development and Regulatory affairs.
• Manage project timelines and coordinate stakeholder efforts for timely delivery.
• Ensure adherence to strict client processes, templates, and regulatory guidelines.

Requirements:

• Minimum of 5 years' experience in medical writing.
• Bachelor’s degree or higher in a relevant scientific discipline.
• Therapeutic area experience in Oncology, Infectious Disease, or Vaccines is a strong asset.
• Proficiency in document management systems and Microsoft Office Suite.
• Exceptional written and verbal communication skills in English.

This is a significant opportunity for career advancement and to contribute to groundbreaking pharmaceutical research, offering competitive compensation and professional growth.

Skills

• 5+ years of medical writing experience in CRO/biotech/pharmaceutical industry
• Bachelor’s degree or higher in a relevant field
• Experience in Oncology, Infectious Disease, or Vaccine therapeutic areas is desired
• Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents
• Flexibility to work across multiple therapeutic areas
• Familiarity with structured content management and lean authoring approaches
• Knowledge of 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
• Ability to adapt to new tools and technologies
• Ability to work independently and collaboratively
• Service-oriented and proactive approach to project management
• Excellent conflict management and negotiation skills
• Strong written and verbal communication skills in English

Duties and Responsibilities:

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

How to apply

To apply for this esteemed Senior Medical Writer role with TransPerfect in Spain, please follow these detailed steps:

• Visit the Application Portal: Navigate to the official Eurojobs website and locate the specific job advertisement for the Senior Medical Writer position.
• Click 'Apply Now': On the job listing page, find and click the 'Apply Now' button to initiate your application process.
• Complete Application Form: You will be directed to an online application form. Fill in all required personal and professional details accurately and comprehensively.
• Upload Required Documents: Prepare and upload your most recent Curriculum Vitae (CV), academic transcripts, relevant certifications, and any other supporting documents as requested by the application system.
• Review and Submit: Carefully review all entered information and uploaded documents for accuracy before submitting your application. Successful candidates will benefit from these TransPerfect (represented by JR Spain) jobs Catalunya. Ensure all fields are completed to avoid delays.
• Application Deadline: Please ensure your application is submitted on or before the closing date of December 18, 2026. Late submissions will not be considered.

Important Notes:

• Applications are exclusively accepted through the online portal.
• Ensure your CV highlights your experience in medical writing, clinical regulatory documents, and specific therapeutic areas like Oncology or Vaccines.
• Only shortlisted candidates will be contacted for further steps in the recruitment process.

Take this chance to advance your career in medical writing with a leading global company. 🚀