Remote Medical Writer for Regulatory Submissions & Trials

Placements24; LegKraal Gate; Hybride; ZAR 600 000 - 1 000 000; Plein temps

Avantages offerts par ce poste

Health insurance

Home office allowance

Training & conferences

Flexible hours

Incentives

Résumé du poste

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.

Responsabilités

• 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.

Formation

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

Description du poste

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.