Clinical and regulatory writing expertise drives this Senior Medical Writer role in Kimberley, Northern Cape, focused on accurate pharmaceutical submissions worldwide.
Our client is a contract research organization supporting the pharmaceutical industry. As Senior Medical Writer, you will translate complex clinical data into explicit documents for drug development programs. The work requires regulatory knowledge, scientific accuracy, and meticulous editing across submission materials.
Key Responsibilities:
- Write and finalize clinical protocols, CSRs, IBs, and CTD modules
- Ensure documents comply with ICH, FDA, EMA, and SAHPRA guidelines
- Collaborate with clinical operations, biostatistics, and regulatory affairs teams
- Manage document timelines and project assignments for timely delivery
- Review work from medical writers and external collaborators
Requirements:
- Bachelor's or Master's degree in a relevant field
- At least five years' medical writing experience
- Experience with pharmaceutical trials and regulatory submissions
- Understanding of ICH, GCP, and health authority requirements
- Excellent writing, editing, proofreading, and organizational skills
Bring clinical documentation, regulatory submission, and scientific communication expertise to Senior Medical Writer work in Kimberley.