Senior Medical Writer for Clinical Regulatory Documents in Spain

Further Details

TransPerfect, partnering with JR Spain, is actively recruiting for a Senior Medical Writer position located in Aragón, Spain. This role is fundamental to advancing drug development by producing comprehensive clinical regulatory documents. The successful candidate will spearhead document creation, including protocols, study reports, and investigator brochures, while meticulously following client and agency standards. This employment opportunity emphasizes cross-functional collaboration, requiring close partnership with clinical development, operations, biostatistics, regulatory affairs, and program management teams. The Senior Medical Writer will manage project timelines, coordinate internal and external stakeholders, and ensure the highest quality of documentation. Ideal candidates will possess a strong background in medical writing within the CRO, biotech, or pharmaceutical sectors, with a minimum of five years of experience. Expertise in therapeutic areas such as Oncology, Infectious Disease, or Vaccines is a significant advantage. The role demands flexibility to work across diverse therapeutic areas and a proven ability to adapt to new tools and technologies.

Senior Medical Writer Opportunities in Spain

JR Spain, in collaboration with TransPerfect, is actively seeking a highly organized and motivated Senior Medical Writer to join a leading client's team in Aragón, Spain. This role is integral to the drug development process, focusing on the creation and management of essential clinical regulatory documents. The position demands a proactive approach, strong project management skills, and the ability to foster collaboration across various client teams.

Candidates will be responsible for leading the execution of critical documents, including protocols, study reports, and investigator brochures, ensuring they meet stringent client and agency guidelines. A deep understanding of document management systems and a commitment to quality are paramount. This is a fantastic chance to advance your career in a stimulating international environment.

• Job Title: Senior Medical Writer
• Location: Aragón, Spain
• Key Responsibilities: Document planning, preparation, and execution; cross-functional team coordination; adherence to regulatory guidelines.
• Required Experience: 5+ years in medical writing within CRO, biotech, or pharmaceutical sectors.
• Therapeutic Area Experience: Oncology, Infectious Disease, or Vaccine experience is desirable.

Skills

• Lead document execution and project management tasks
• Create, maintain, and communicate project timelines
• Coordinate cross-functional client contributors and stakeholders
• Ensure timely document completion
• Adhere to relevant client processes, templates, and instructional documents
• Serve as an expert on client document management systems and tools
• Lead document message development in collaboration with clients
• Interpret data and create shell documents
• Plan and lead kickoff meetings
• Facilitate resolution of review feedback
• Conduct literature searches as needed
• Perform peer QC review as needed
• Contribute to medical writing operational initiatives
• 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 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 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
• 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 (curate review comments to ensure meetings are efficient)
• 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

• 💼 Prepare Your Application: Ensure your CV is updated and highlights relevant medical writing experience, particularly in clinical regulatory documents.
• 🎓 Review Qualifications: Confirm you meet the minimum requirement of 5+ years of experience as a medical writer in the CRO/biotech/pharmaceutical field and hold a Bachelor’s degree or higher in a relevant discipline.
• 🔎 Gather Supporting Documents: Be ready to provide any necessary certificates or degrees that validate your qualifications.
• 📌 Access Application Portal: Visit the eurojobs.com website and navigate to the specific job listing.
• 👉 Submit Your Application: Click on the 'Apply' button to be directed to the application portal. This position represents excellent JR Spain Client / Employer: TransPerfect jobs Aragón in the region. Follow the on-screen instructions to submit your application.
• ⏳ Application Deadline: Please ensure your application is submitted by 18.12.2026.
• 🌐 Learn More: For more details about TransPerfect, visit their official website.