Senior Medical Writer Opportunity in Spain - Lead Clinical Document Development

Further Details

This Senior Medical Writer position in Andalucía, Spain, is ideal for seasoned professionals seeking to make a significant impact in the biopharmaceutical industry. The role involves leading the development of high-quality clinical regulatory documents, collaborating closely with client teams across Clinical Development, Regulatory, and Program Management. You will be responsible for project management tasks, ensuring timely completion and adherence to stringent guidelines. The role requires a Bachelor's degree or higher, with a strong preference for individuals with experience in Oncology, Infectious Disease, or Vaccine development. Opportunities abound for a Senior Medical Writer to excel in document message development, data interpretation, and facilitating efficient review and comment resolution meetings. Expertise in document management systems and collaborative authoring tools is highly valued. If you possess strong written and verbal communication skills, a proactive approach to project management, and a desire to contribute to cutting-edge drug development, this role in Spain offers a compelling career trajectory.

Senior Medical Writer | Spain

JR Spain, on behalf of its client TransPerfect, is actively seeking a highly skilled and motivated Senior Medical Writer to join their esteemed team in the picturesque region of Andalucía, Spain. This role presents a significant opportunity for experienced medical writing professionals to contribute to impactful drug development projects within a globally recognized organization. Additionally, high salary jobs are available for qualified candidates. The ideal candidate will possess a strong understanding of clinical regulatory document creation and a proven track record of successful project management.

This key position involves leading the planning and preparation of high-quality clinical regulatory documents, collaborating closely with diverse client teams. Responsibilities encompass managing timelines, coordinating stakeholders, and ensuring adherence to strict client and agency guidelines. A Bachelor’s degree or higher is required, with a preference for candidates with specific experience in therapeutic areas such as Oncology, Infectious Disease, or Vaccine development. Familiarity with established processes, document templates, and structured content management approaches is highly advantageous.

• Job Title: Senior Medical Writer
• Location: Andalucía, Spain
• Company: TransPerfect (via JR Spain)
• Key Responsibilities: Lead document execution, project management, cross-functional coordination, document message development, data interpretation, review facilitation.
• Required Experience: 5+ years in medical writing (CRO/biotech/pharmaceutical)
• Essential Qualifications: Bachelor’s degree or higher, strong English communication skills.
• Desirable Experience: Oncology, Infectious Disease, Vaccine development; writing specific clinical documents.
• Tools & Systems: Proficiency with Microsoft Office, document management systems, collaborative authoring/review tools.

Skills

• 5+ years of experience as a medical writer in CRO/biotech/pharmaceutical field
• Bachelor’s degree or higher in a relevant field
• 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 preparation of key clinical and regulatory documents, including ICH and US regulatory requirements
• Working knowledge of ex-US regulatory requirements is 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
• 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 Eligibility: Ensure you meet the core requirements, including at least 5 years of medical writing experience in the CRO, biotech, or pharmaceutical sectors and a Bachelor's degree or higher.
• Prepare Application Documents: Compile a comprehensive CV/resume detailing your experience, qualifications, and relevant therapeutic area expertise.
• Visit the Application Portal: Navigate to the official application link provided for this vacancy.
• Submit Your Application: Complete the online application form accurately and submit your prepared documents through the designated portal.
• Confirmation: You should receive a confirmation of your application submission.
• Note on EU Work Permit: This role explicitly states that an EU work permit is required, so ensure you possess the necessary authorization to work in Spain.
• Deadline: Please ensure your application is submitted on or before the closing date of December 18, 2026.

Application Link:Click here to apply now

Important Note: For any direct inquiries or further information, please refer to the contact details or the eurojobs.com website as provided in the original advertisement.

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