Senior Clinical Regulatory Medical Writer

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 clear 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 modulesEnsure documents comply with ICH, FDA, EMA, and SAHPRA guidelinesCollaborate with clinical operations, biostatistics, and regulatory affairs teamsManage document timelines and project assignments for timely deliveryReview work from medical writers and external collaboratorsRequirements:
Bachelor's or Master's degree in a relevant fieldAt least five years' medical writing experienceExperience with pharmaceutical trials and regulatory submissionsUnderstanding of ICH, GCP, and health authority requirementsExcellent writing, editing, proofreading, and organizational skillsBring clinical documentation, regulatory submission, and scientific communication expertise to Senior Medical Writer work in Kimberley.
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