Senior Medical Writer - Pharmaceutical Submissions

About the RoleOur client, a leading contract research organization (CRO) supporting the pharmaceutical industry, is seeking a highly skilled Senior Medical Writer to join their dedicated team in Kimberley, Northern Cape. This role is essential for the preparation of high-quality clinical and regulatory documents required for drug development and submission to health authorities worldwide. The Senior Medical Writer will be responsible for translating complex scientific and clinical data into clear, concise, and accurate documents, ensuring compliance with regulatory guidelines and company standards. This is an exciting opportunity for an experienced writer to contribute to a variety of drug development programs and work in a supportive, growth-oriented environment. We are looking for a meticulous professional who can deliver excellence in scientific communication from our Kimberley offices.
Key Responsibilities
Write, edit, and finalize a variety of clinical and regulatory documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submission documents (e.G., CTD modules).
Ensure all documents are scientifically accurate, clear, concise, and compliant with relevant guidelines (e.G., ICH, FDA, EMA, SAHPRA).
Collaborate closely with internal teams, including clinical operations, biostatistics, data management, regulatory affairs, and subject matter experts.
Manage document development timelines and project assignments to ensure timely delivery.
Review and edit documents written by other medical writers and external collaborators.
Contribute to the development and maintenance of company style guides and templates.
Participate in cross-functional team meetings and provide expertise on medical writing best practices.
Stay updated on regulatory requirements and industry trends related to medical writing and regulatory submissions.
Maintain a high level of scientific and technical understanding across various therapeutic areas.
Ensure consistency and accuracy of information across all submitted documents.
Contribute to process improvements within the medical writing department in Kimberley .
Requirements
Requirements Bachelor's or Master's degree in a life science, English, Journalism, or a related field.
Minimum of 5 years of experience as a Medical Writer, with a significant focus on pharmaceutical clinical trial documentation and regulatory submissions.
In-depth understanding of ICH guidelines, GCP, and regulatory submission requirements for key health authorities.
Proven ability to interpret and present complex clinical and scientific data effectively.
Excellent writing, editing, and proofreading skills with meticulous attention to detail.
Strong organizational and project management skills, with the ability to manage multiple projects simultaneously.
Proficiency in using document management systems and common office software.
Ability to work independently and collaboratively in a fast-paced, deadline-driven environment.
Excellent interpersonal and communication skills.
Experience in multiple therapeutic areas is an asset.
Benefits
Benefits include robust health insurance options, paid time off, and a retirement savings plan.
We provide ongoing professional development opportunities, including training programs and support for attending relevant industry workshops and conferences.
This role is based in our professional office in Kimberley, offering a supportive and dynamic work environment where your contributions are valued.
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