Senior Medical Writer - Regulatory Affairs

Placements24; Polokwane; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Professional development

Career advancement

Job summary

Placements24 in Polokwane seeks a Senior Medical Writer to author, edit and review regulatory documents for global submissions, including INDs, NDAs, and CSRs. You will ensure scientific accuracy and adherence to ICH guidelines, collaborating with clinical operations and regulatory affairs.

You will mentor junior writers, manage timelines, and contribute to SOPs while supporting multi-therapeutic projects across a CRO environment.

Qualifications

• Bachelor's degree in a scientific or healthcare-related field.
• 5–7 years of progressive experience in medical writing within the pharmaceutical/biotech/CRO industry.
• Expertise in authoring regulatory documents such as INDs, NDAs, CSRs and familiarity with ICH guidelines.

Responsibilities

• Author, edit, and finalize clinical and regulatory documents (CSRs, protocols, investigator brochures, CTDs, briefing documents).
• Coordinate with cross-functional teams to ensure timely, compliant submissions and accurate information.
• Mentor junior writers and contribute to SOPs and style guides.

Skills

Medical writing

Regulatory submissions

Regulatory guidelines

Education

Bachelor's degree in science/healthcare

Advanced degree (Master's or Ph.D.)

Tools

MS Office

Regulatory DMS

Job description

About the Role

Our client, a leading global contract research organization (CRO), is seeking a highly experienced Senior Medical Writer to join their Regulatory Affairs department based in Polokwane . This role is critical for the preparation of high-quality regulatory submission documents for global health authorities. The Senior Medical Writer will be responsible for authoring, editing, and reviewing a variety of clinical and regulatory documents, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Clinical Study Reports (CSRs), and safety updates. The ideal candidate possesses a deep understanding of drug development processes, regulatory guidelines, and therapeutic areas, coupled with exceptional writing and communication skills. This position offers the opportunity to work on diverse projects across multiple therapeutic areas and contribute to bringing life-saving medicines to patients worldwide. We are committed to fostering a collaborative and knowledge-sharing environment in Polokwane .

Key Responsibilities

Author, edit, and finalize a wide range of clinical and regulatory documents, including CSRs, protocols, investigator brochures, CTDs, and briefing documents. Ensure all documents are scientifically accurate, clearly written, and compliant with relevant regulatory guidelines (e.g., ICH, FDA, EMA). Collaborate closely with project teams, including clinical operations, regulatory affairs, statistics, and medical affairs, to gather necessary information and ensure alignment. Manage document development timelines, coordinate review cycles, and address feedback from internal and external stakeholders. Stay updated on regulatory requirements and industry best practices related to medical writing and drug development. Provide guidance and mentorship to junior medical writers and contribute to the development of departmental SOPs and style guides. Serve as a key point of contact for clients regarding medical writing aspects of their projects in Polokwane . Contribute to strategic discussions regarding regulatory submission planning and document content. Ensure consistency in style, tone, and quality across all written documentation.

Requirements

Bachelor's degree in a scientific or healthcare-related field; advanced degree (Master's or Ph.D.) preferred. A minimum of 5-7 years of progressive experience in medical writing within the pharmaceutical, biotechnology, or CRO industry. Proven expertise in authoring complex regulatory documents, such as INDs, NDAs, and CSRs. In-depth knowledge of ICH guidelines and regulatory submission requirements in major markets (e.g., US, EU). Exceptional written and verbal communication skills, with a keen eye for detail and accuracy. Strong project management skills, with the ability to manage multiple projects simultaneously and meet tight deadlines. Ability to work independently and collaboratively within a cross-functional team environment in Polokwane . Proficiency in Microsoft Office Suite and experience with regulatory document management systems is a plus. Understanding of clinical trial design and statistical principles is essential.

Benefits

Our client offers a competitive salary, comprehensive health and wellness benefits, a retirement savings plan, and opportunities for professional development and career advancement. Employees will benefit from working on diverse and impactful projects, collaborating with a team of experienced professionals in Polokwane . We provide a supportive and dynamic work environment that values quality, efficiency, and client satisfaction. Opportunities for continued learning and attending industry conferences are available. Join a leading CRO making a significant contribution to global health.