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