06 Sep
|
Placements24
|
Kimberley
06 Sep
Placements24
Kimberley
About the Role
Our client is seeking an experienced and highly skilled Senior Medical Writer to join their medical affairs department in Kimberley . This role is essential for creating transparent, accurate, and scientifically sound documents that communicate complex medical and scientific information effectively. You will be responsible for developing a range of regulatory, scientific, and educational documents for various audiences, including health authorities, healthcare professionals, and patients. The ideal candidate possesses exceptional writing skills, a deep understanding of pharmaceutical research and development, and the ability to manage multiple projects simultaneously in a demanding environment. This is a vital role in ensuring effective communication of medical data and supporting regulatory submissions and scientific exchange.
Key Responsibilities
- Write, edit, and review a variety of medical documents, including clinical study reports (CSRs), investigator brochures, regulatory submission documents, manuscripts, and abstracts.
- Ensure all documents are scientifically accurate, clearly written, and comply with relevant guidelines (e.g., ICH, FDA, EMA) and company standards.
- Collaborate closely with cross-functional teams, including R&D;, clinical operations, regulatory affairs, and marketing, to gather information and ensure alignment.
- Manage document development timelines and budgets to ensure timely completion of projects.
- Stay current with therapeutic area advancements, regulatory requirements, and best practices in medical writing.
- Mentor junior medical writers and contribute to the development of internal style guides and templates.
Requirements
- Bachelor's degree in a life science, health science, or related field; advanced degree (Master's or Ph.D.) preferred.
- Minimum of 5 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
- Proven ability to write and edit complex scientific and medical documents for diverse audiences.
- In-depth knowledge of clinical trial processes, regulatory submission requirements, and scientific publication standards.
- Excellent organizational, project management, and communication skills.
- Proficiency in Microsoft Office Suite and familiarity with document management systems.
Benefits
- Competitive annual salary and performance-based bonus opportunities.
- Comprehensive medical, dental, and vision insurance.
- Generous paid time off and retirement savings plan.
- Support for continuing education and professional development.
- Opportunity to work on important medical and regulatory documents in Kimberley.
📌 Senior Medical Writer (Kimberley)
🏢 Placements24
📍 Kimberley