Senior Medical Writer - Clinical Regulatory Documents

Further Details

Join a leading global organization as a Senior Medical Writer, instrumental in producing vital clinical regulatory documents. This role demands exceptional organizational and communication skills to effectively partner with diverse client teams. You will oversee the development of critical documents, manage project timelines, and ensure adherence to stringent industry standards, fostering efficient drug development. This position offers a platform to refine your skills in document management, data interpretation, and cross-functional collaboration. By interpreting complex data and facilitating constructive review processes, you will significantly contribute to the success of cutting-edge drug development programs. Experience in oncology, infectious disease, or vaccine development is a valuable asset for this role.

Senior Medical Writer - Clinical Regulatory Document Specialist

TransPerfect is actively recruiting a skilled Senior Medical Writer for their operations in Madrid, Spain. This vital role supports global drug development by ensuring the creation of high-quality clinical regulatory documents. The position requires a professional with proven experience in the pharmaceutical or biotech sector, capable of leading document lifecycle management and collaborating effectively with diverse teams.

This opportunity focuses on managing the entire document development process, from initial planning and data interpretation to final review and submission. Successful candidates will be adept at navigating complex project timelines and client-specific requirements, fostering a collaborative environment for optimal document output. Experience in therapeutic areas such as Oncology, Infectious Disease, or Vaccines is highly desirable, alongside a strong command of English and proficiency with relevant software.

• Job Title: Senior Medical Writer
• Location: Madrid, Spain
• Company: TransPerfect
• Required Experience: 5+ years in medical writing
• Key Responsibilities: Document leadership, project management, cross-functional coordination, adherence to standards
• Key Qualifications: Bachelor's degree or higher, therapeutic area experience, strong communication skills
• Application Deadline: 18 December 2026

Skills

• Leading document execution and project management tasks
• Creating, maintaining, and communicating project timelines
• Coordinating cross-functional client contributors and internal resources
• Ensuring timely document completion and adherence to client processes
• Serving as an expert on client document management systems and tools
• Developing document messages in collaboration with clients
• Interpreting data and creating shell documents
• Leading kickoff meetings and comment resolution meetings
• Conducting literature searches as needed
• Performing peer QC reviews
• Contributing to medical writing operational initiatives
• Excellent conflict management and negotiation skills
• Strong written and verbal communication skills in English
• Ability to work independently and collaboratively

Duties and Responsibilities:

• Lead the execution of documents, including project management tasks
• Coordinate cross-functional client contributors and internal resources
• Ensure document development adheres to client processes, templates, and instructions
• Serve as an expert on client document management system and related tools
• Interpret data and create shell documents to support authoring
• Plan and lead kickoff meetings
• Facilitate resolution of review feedback
• 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 if needed

How to apply

• Step 1: Visit the Eurojobs platform to find the Senior Medical Writer position in Madrid.
• Step 2: Locate and click on the 'Apply Now' link provided for this vacancy.
• Step 3: You will be redirected to the TransPerfect application portal or a dedicated application page.
• Step 4: Complete the online application form with accurate personal and professional details.
• Step 5: Upload your comprehensive Curriculum Vitae (CV) showcasing your relevant experience, particularly in clinical regulatory document writing.
• Step 6: Ensure your CV highlights your experience in therapeutic areas such as Oncology, Infectious Disease, or Vaccines, if applicable.
• Step 7: Be prepared to submit any additional documents requested during the online application process.
• Step 8: Review all entered information carefully before final submission.
• Step 9: Note the closing date for applications: 18 December 2026.
• Step 10: Acknowledge that EU work permit is required for this role.