Freelance Senior Medical Writer

Title: Freelance Senior Medical Writer

Location: Spain

Contract Type: Freelance

Are you looking for an exciting job in the field of life science working in a dynamic and international environment?

Haybury are partnered with some of the world’s largest global biotechnology companies located in Spain. As a Senior Medical Writer you will take responsibility for crafting clinical documents intended for submission to global regulatory bodies. You will be involved in working with interdisciplinary project teams to ensure clinical documents such as Clinical Study Reports (CSRs) and Investigators Brochures (IBs) are accurately presented and aligned to regulatory mandates.

Key responsibilities:

• Create and develop regulatory documents for submission to global regulatory agencies, whilst adhering to ICH and other relevant global guidelines, standards, and processes
• Mentor Associate Medical Writers across all medical writing activities
• Contribute to medical writing deliverables, timelines, and necessary processes during cross-functional meetings
• Review Protocols and Statistical Analysis plans whilst also participating in cross-functional initiatives to improve project success
• Contribute to the development of standard operating procedures and best practices for efficient preparation of quality documents
• Write study documents such as protocols, informed consent documents (ICF, investigator brochures (IB), clinical study reports (CSRs), and other documents in accordance with regulatory requirements

Key requirements:

• Bachelor's degree required; an advanced degree in a relevant scientific/clinical/regulatory field is preferred
• Strong organisational, time management, and project management skills are essential
• Expert understanding of global regulatory requirements; familiarity with therapeutic areas across all phases of clinical development
• Strong medical writing experience in the pharmaceutical or biotechnology industry, with equivalent experience in clinical development across all phases
• Ability to communicate well at all levels to both clinical and non clinical stakeholders both verbal and written communication in English
• Strong organisational, time management, and project management skills are essential

If you have the skills and experience for this opportunity, then please apply or email Loren your CV today to loren.cardy@hayburysearch.com.

Loren is a Client Partner at Haybury Search covering Europe, UK, North America and Asia.