Senior Medical Writer Opportunity in Spain

Further Details

Seeking a skilled Senior Medical Writer to join a leading pharmaceutical client in Euskadi, Spain. This position demands a deep understanding of clinical regulatory document preparation and cross-functional collaboration. The ideal candidate will manage project timelines and ensure adherence to strict guidelines. This role involves partnering with teams across Clinical Development, Operations, Biostatistics, and Regulatory Affairs. You will play a key part in producing essential documents such as protocols, study reports, and investigator brochures, contributing significantly to the drug development lifecycle. Focus on oncology, infectious disease, or vaccine experience is highly valued for this essential position. Bring your expertise in document management systems and a proactive approach to project management to excel in this international career opportunity.

Senior Medical Writer Career Opportunities in Spain

JR Spain, on behalf of their client TransPerfect, is actively seeking a skilled Senior Medical Writer to join their esteemed team in Euskadi, Spain. This is a remarkable opportunity for experienced professionals aiming to advance their careers in a crucial role within the pharmaceutical industry. The position focuses on the meticulous creation and management of high-quality clinical regulatory documents essential for drug development.

This role requires a proactive individual with a strong track record in medical writing, particularly within the CRO, biotech, or pharmaceutical sectors. Successful candidates will benefit from these Pharmaceuticals jobs in Euskadi. You will be instrumental in leading cross-functional efforts, ensuring that all documentation adheres to stringent client and agency guidelines, and is delivered efficiently within tight deadlines.

Key Highlights:

• Job Title: Senior Medical Writer
• Location: Euskadi, Spain
• Employer: TransPerfect (Client of JR Spain)
• Key Responsibilities: Document execution, project management, cross-functional coordination, adherence to guidelines.
• Required Experience: 5+ years in medical writing.
• Desired Therapeutic Areas: Oncology, Infectious Disease, or Vaccine experience.
• Benefits: Opportunity for professional growth, contribution to drug development, international work experience.

Skills

• 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 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
• 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

Interested candidates are encouraged to submit their applications through the official application portal. Please ensure all required documentation is prepared prior to applying to streamline the process.

• 💼 Prepare your CV: Ensure your Curriculum Vitae is up-to-date and highlights your relevant experience in medical writing, particularly in the pharmaceutical or biotech sectors.
• 🎓 Gather Qualifications: Have digital copies of your Bachelor's degree and any relevant certifications or supporting documents readily available.
• 📌 Review Job Details: Carefully read through the responsibilities and required skills to confirm your suitability for the Senior Medical Writer role.
• 👉 Visit the Application Link: Navigate to the provided application link to begin the online submission process.
• 📝 Complete Application Form: Fill out the online application form accurately and completely.
• ⏳ Submit Before Deadline: Ensure your application is submitted on or before the closing date of December 18, 2026.
• 🌐 Application Portal: Apply directly via the Eurojobs platform.