Senior Medical Writer - Clinical Regulatory Documents in Spain

Further Details

JR Spain, partnering with TransPerfect, seeks a dedicated Senior Medical Writer to support critical drug development initiatives within Spain. This role is instrumental in leading the planning and execution of essential clinical regulatory documents. Your expertise will be vital in coordinating cross-functional teams, managing project timelines, and ensuring the highest quality standards are met for protocols, study reports, and investigator brochures. Leverage your understanding of client document management systems and processes to drive efficient document development. You will play a key role in interpreting complex data, developing document structures, and facilitating effective review comment resolution meetings. This position offers a unique opportunity to contribute to the advancement of therapeutic areas such as Oncology and Infectious Diseases, working within a globally recognized organization. Ideal candidates will demonstrate a proven track record of over five years in medical writing within the CRO, biotech, or pharmaceutical industry. A Bachelor's degree or higher in a relevant scientific discipline is required, with a preference for candidates experienced in writing specific clinical and regulatory documents and familiarity with lean authoring approaches.

Senior Medical Writer - Clinical Regulatory Document Specialist in Spain

The pharmaceutical and biotechnology sectors are continually advancing, requiring skilled professionals to navigate the complex landscape of clinical regulatory documentation. JR Spain, representing TransPerfect, is actively seeking an experienced Senior Medical Writer to join their esteemed team in Cantabria, Spain. This pivotal role is designed for individuals with a robust background in medical writing, who can effectively lead the creation of essential clinical and regulatory documents under demanding project timelines. This position offers a unique opportunity to contribute to groundbreaking drug development projects, working in close collaboration with a diverse group of client stakeholders. You will be instrumental in project management, ensuring timely document delivery, and maintaining the highest standards of quality and consistency. The role requires a deep understanding of document management systems and best practices in scientific communication. Successful candidates will benefit from these Medical Writer jobs Cantabria. Key highlights of this exciting career opportunity include: * **Job Title:** Senior Medical Writer * **Location:** Cantabria, Spain * **Company:** JR Spain (Client: TransPerfect) * **Posting Date:** 03 November 2026 * **Closing Date:** 18 December 2026 * **Required Experience:** 5+ years in medical writing within CRO/biotech/pharmaceuticals * **Key Document Types:** Protocols, study reports, investigator brochures, module documents * **Therapeutic Areas:** Oncology, Infectious Disease, Vaccine experience is a plus * **Essential Skills:** Microsoft Office Suite, document management systems, strong communication and project management abilities * **Work Permit:** EU work permit not required

Skills

• Experience (5+ years) 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 desired in writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents
• Flexibility to work across multiple therapeutic areas, if needed
• 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 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, if needed
• Ability to work both independently and collaboratively in the face of competing priorities
• 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

Talented and experienced medical writers are invited to submit their applications for this exciting opportunity with JR Spain, representing TransPerfect, for their Cantabria, Spain-based role. 📝 **Application Process:** * 👉 **Visit the Official Application Portal:** Access the direct application link provided on Eurojobs.com. Successful candidates will benefit from these latest recruitment. * 🌐 **Complete the Online Application Form:** Fill out all required fields accurately and thoroughly, detailing your professional experience and qualifications. * 📄 **Upload Required Documents:** Ensure your application includes your most recent Curriculum Vitae (CV) and any supporting documentation that substantiates your skills and experience. * 🗓️ **Submit Before Deadline:** All applications must be submitted by the closing date of 18 December 2026. ⚠️ **Important Considerations:** * TransPerfect is committed to providing equal employment opportunities. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, gender, age, sexual orientation, national origin, disability, or veteran status. * Ensure your qualifications, particularly your 5+ years of experience in medical writing and relevant degree, align with the specified requirements for this role.