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 transparent 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.