Walker Cole International is seeking a Senior Medical Writer to work remotely for a European pharmaceutical company specializing in immunotherapy.

In this role, you will support the Research and Development (R&D) department by handling all medical writing tasks.

Your key responsibilities will include:

• Writing and developing essential clinical documents such as Investigator Brochures (IBs), study protocols, and Clinical Study Reports (CSRs) to support clinical development.
• Organizing and compiling data for clinical documents like the Investigational Medicinal Product Dossier (IMPD) and contributing to the clinical sections of Common Technical Document (CTD) modules.
• Assisting with clinical publications (e.g. abstracts, posters, manuscripts).
• Ensuring timely completion of all writing projects to support R&D objectives and facilitate the submission of regulatory dossiers.

Key qualifications for the role include:

• A master’s degree in a relevant scientific field.
• Extensive experience in medical writing within the pharmaceutical or biotech industry.
• Proven ability to author and edit key clinical documents such as protocols and CSRs for Phase 1-3 studies.

Medical Writing | Pharmaceutical | Biotech | Scientific Writing | Medical Affairs | CSR | IB | CTD | Protocol | Clinical Documents | Clinical Trials | Immunotherapeutics | Research & Development | Medical Communications