Senior Medical Writer - Clinical Document Expertise in Spain

Further Details

TransPerfect, a leading organization, is recruiting a Senior Medical Writer to enhance their clinical document development efforts in Spain. This role involves collaborating with diverse client departments, including Clinical Development and Regulatory Affairs, to produce high-quality clinical regulatory documents. The position requires a candidate adept at managing project timelines and ensuring adherence to established client protocols and templates for optimal drug development outcomes. This career opportunity focuses on producing key documentation such as protocols, study reports, and investigator brochures, all within accelerated project timelines. The Senior Medical Writer will play a pivotal role in message development, data interpretation, and facilitating review feedback to ensure consistency and accuracy across all client programs. This is a chance to work with advanced document management systems and contribute to operational initiatives within the medical writing field.

Senior Medical Writer - Clinical Document Expertise in Spain

JR Spain, on behalf of their client TransPerfect, is actively seeking a highly organized and motivated Senior Medical Writer to join their dynamic team. This role is crucial for leading the planning and preparation of essential clinical regulatory documents, partnering closely with cross-functional client teams. Ideal candidates will possess a strong understanding of drug development timelines and client guidelines.

This position offers an excellent opportunity to contribute to global healthcare advancements by producing protocols, publications, study reports, and investigator brochures. The Senior Medical Writer will leverage their expertise to ensure all documents adhere to strict quality standards and client-specific processes, facilitating efficient drug development under demanding schedules.

Key Positions Available:

• Job Title: Senior Medical Writer
• Location: Islas Baleares, Spain
• Qualifications: Bachelor's degree or higher in a relevant field
• Experience: 5+ years as a medical writer in the CRO/biotech/pharmaceutical field
• Key Responsibilities: Document leadership, project management, cross-functional coordination, quality assurance, data interpretation, and client collaboration.
• Desired Experience: Oncology, Infectious Disease, or Vaccine therapeutic areas; writing clinical study reports, protocols, amendments, investigator brochures, module 2 and 5 documents.

Apply now for this exciting international career opportunity!

Skills

• Experience in clinical document development (5+ years)
• Proficiency in Microsoft Word and other Microsoft applications
• Expertise in document management systems and collaborative authoring tools
• Excellent written and verbal communication skills in English
• Strong project management and organizational abilities
• Ability to work independently and collaboratively
• Conflict management and negotiation skills
• Experience with ICH and US regulatory requirements
• Experience in Oncology, Infectious Disease, or Vaccine therapeutic areas (desired)

Duties and Responsibilities:

• Lead the planning and preparation of high-quality clinical regulatory documents
• Partner cross-functionally with client teams in Clinical Development, Operations, Biostatistics, Regulatory, and Program Management
• Produce protocols, publications, study reports, investigator brochures, narratives, and module documents
• Manage project timelines, including creating, maintaining, and communicating schedules
• Coordinate internal and external resources to ensure timely document completion
• Ensure document development adheres to client processes, templates, and instructional documents
• Serve as an expert on client document management systems and related tools
• Lead document message development in collaboration with clients
• Interpret data and create shell documents for authoring
• Plan and lead kickoff and comment resolution meetings
• Facilitate resolution of 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

How to apply

• Review Job Details: Thoroughly read the job description and requirements for the Senior Medical Writer position in Islas Baleares, Spain.
• Prepare Your Application: Ensure your CV and any supporting documents clearly highlight your relevant experience, including your 5+ years as a medical writer and specific therapeutic area expertise (Oncology, Infectious Disease, Vaccine).
• Visit the Application Portal: Navigate to the official application link provided.
• Submit Your Application: Follow the on-screen instructions to complete and submit your application through the Eurojobs portal.
• Application Deadline: Ensure your application is submitted before the closing date of 18th December 2026.
• Confirmation: Look out for a confirmation email after successfully submitting your application.