Medical Writer

Placements24; LegKraal Gate; Hybrid; ZAR 600,000 - 1,000,000; Full time

Benefits offered by this job

Health insurance

Home office allowance

Training & conferences

Flexible hours

Incentives

Job summary

Placements24 is seeking a talented Medical Writer to join their globally distributed, remote-first medical affairs team. You will develop clear, scientifically sound documents for regulatory submissions, clinical trial reporting, and publications.

Collaborate with medical, regulatory, and research teams to translate complex data into concise language, ensure regulatory compliance, and meet strict timelines in a fully remote environment.

Qualifications

• Advanced degree (Master's or Ph.D.) in Life Sciences, Pharmacy, Medicine, or related field.
• Minimum of 5 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
• Demonstrated expertise in writing clinical trial documentation and regulatory submissions.
• Thorough understanding of ICH guidelines and other regulatory requirements.
• Exceptional written and verbal communication skills, with a keen eye for detail.
• Proven ability to work independently, manage multiple projects, and meet deadlines in a remote environment.

Responsibilities

• Author, edit, and review medical documents including CSRs, protocols, investigator brochures, and regulatory submission documents.
• Translate complex scientific and clinical data into clear, concise language for target audiences.
• Ensure documents comply with regulatory guidelines (ICH, FDA, EMA) and internal SOPs.
• Collaborate with internal and external stakeholders to gather information and ensure scientific accuracy.
• Manage document timelines and deliverables in a remote work setting.
• Contribute to development and maintenance of style guides and templates.

Education

Master's or Ph.D. in Life Sciences, Pharmacy, Medicine, or related field

Job description

About the Role

Our client is seeking a talented and experienced Medical Writer to join their globally distributed, remote-first medical affairs team. This role is pivotal in developing clear, accurate, and scientifically sound documents essential for regulatory submissions, clinical trial reporting, and scientific publications. You will collaborate closely with cross-functional teams, including medical, regulatory, and research personnel, leveraging virtual communication tools to ensure alignment and timely delivery of high-quality content. This position is ideal for a writer who thrives in a remote environment and is passionate about communicating complex medical information effectively.

Key Responsibilities

• Author, edit, and review a variety of medical documents, including clinical study reports (CSRs), protocols, investigator brochures, and regulatory submission documents.
• Translate complex scientific and clinical data into clear, concise, and accurate language suitable for target audiences.
• Ensure all documents comply with relevant regulatory guidelines (e.g., ICH, FDA, EMA) and internal SOPs.
• Collaborate with internal and external stakeholders to gather information and ensure scientific accuracy.
• Manage document timelines and deliverables in a remote work setting.
• Contribute to the development and maintenance of style guides and templates.

Requirements

• Advanced degree (Master's or Ph.D.) in Life Sciences, Pharmacy, Medicine, or a related field.
• Minimum of 5 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
• Demonstrated expertise in writing clinical trial documentation and regulatory submissions.
• Thorough understanding of ICH guidelines and other relevant regulatory requirements.
• Exceptional written and verbal communication skills, with a keen eye for detail.
• Proven ability to work independently, manage multiple projects, and meet deadlines in a remote environment.

Benefits

• Competitive annual salary and performance-based incentives.
• Comprehensive health, dental, and vision insurance.
• Generous home office equipment and technology allowance.
• Opportunities for professional growth, training, and conference attendance.
• Flexible working hours and a supportive, collaborative remote culture.