Medical Writer - Pharmaceutical Dossiers

Placements24; Upington; On-site; ZAR 520,000 - 780,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Professional development

Job summary

Placements24 is seeking a skilled Medical Writer to join our regulatory affairs team in Upington. This role focuses on producing high-quality, compliant regulatory documentation for drug submissions and lifecycle management, translating complex data into clear, concise documents for health authorities worldwide.

The ideal candidate has a Bachelor's or Master's degree in a scientific field, at least 3 years of medical writing experience, and strong English communication skills.

Job description

About the Role

Our client is seeking a skilled Medical Writer to join their regulatory affairs department based in Upington. This role is crucial for preparing high-quality, accurate, and compliant regulatory documentation required for drug submissions and lifecycle management. You will translate complex scientific and clinical data into clear, concise documents for health authorities worldwide. The ideal candidate will possess exceptional writing skills, a strong understanding of pharmaceutical development, and the ability to work collaboratively with cross-functional teams to ensure timely and successful regulatory submissions.

Key Responsibilities

• Prepare, write, and edit a variety of regulatory documents, including Clinical Study Reports (CSRs), Investigational New Drug (IND) applications, and Common Technical Document (CTD) modules.
• Ensure all documentation is scientifically accurate, grammatically correct, and compliant with relevant regulatory guidelines and company standards.
• Collaborate with subject matter experts (e.g., clinicians, statisticians, regulatory affairs) to gather necessary information and ensure technical accuracy.
• Review and revise documents drafted by others, providing constructive feedback.
• Manage document review processes and ensure timely completion of submission packages.
• Maintain up-to-date knowledge of regulatory requirements and guidelines related to medical writing in Upington.

Requirements

• Bachelor's or Master's degree in a scientific or medical discipline (e.g., Pharmacy, Biology, Chemistry).
• Minimum of 3 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
• Proven experience in writing various regulatory documents, such as CSRs and CTD modules.
• Excellent written and verbal communication skills, with a strong command of English.
• Familiarity with Good Clinical Practice (GCP) and regulatory submission processes.
• Ability to work independently, manage deadlines, and collaborate effectively with diverse teams.

Benefits

• Competitive annual salary and potential for performance-based increases.
• Comprehensive health insurance and retirement plan.
• Paid time off and opportunities for professional development.
• Exposure to a wide range of pharmaceutical products and regulatory submissions.
• A supportive work environment that values scientific accuracy and regulatory compliance.