Remote Pharma Medical Writer — CSR & Regulatory Docs

Placements24; East London; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits

Career growth

Job summary

Placements24 is seeking a Pharmaceutical Medical Writer to join our client's regulatory affairs team remotely. You will create clear, accurate medical writing for CSR, IBs, CTD modules, and regulatory submissions, ensuring compliance with ICH, FDA, EMA, and SAHPRA.

You will collaborate with R&D, regulatory, and clinical teams while working from home. Candidates should hold a life science degree (BSc or MSc) and have at least 3 years of pharma/biotech medical writing experience, with proven CSR

Qualifications

• Bachelor's or Master's degree in a life science discipline (e.g., Pharmacy, Biology, Biochemistry, Medicine).
• Minimum of 3 years of experience in medical writing within the pharmaceutical or biotechnology industry.
• Demonstrated expertise in writing clinical study reports (CSRs) and regulatory submission documents.
• In-depth understanding of ICH guidelines and regulatory submission requirements.
• Excellent written and verbal communication skills, with a strong command of scientific and medical terminology.
• Proven ability to interpret complex scientific data and present it clearly and concisely.
• Strong organizational skills, attention to detail, and ability to manage multiple projects.

Responsibilities

• Write, edit, and review a wide range of medical and scientific documents, including clinical study reports (CSRs), protocols, Investigator's Brochures (IBs), and regulatory submission documents (e.g., CTD modules).
• Ensure all documentation is scientifically accurate, clear, concise, and compliant with relevant regulatory guidelines (e.g., ICH, FDA, EMA, SAHPRA).
• Collaborate effectively with internal stakeholders, including R&D scientists, clinicians, regulatory affairs professionals, and marketing teams.
• Manage multiple writing projects simultaneously, adhering to strict deadlines and quality standards.
• Contribute to the development of scientific publications and presentations.
• Maintain up-to-date knowledge of therapeutic areas, scientific advancements, and regulatory requirements.
• Ensure consistency in terminology, style, and formatting across all documents.
• Review and provide feedback on documents drafted by other team members.
• Assist in the development of plain language summaries for various stakeholders.

Education

Bachelor's or Master's degree in life sciences

Job description

Placements24 is seeking a Pharmaceutical Medical Writer to join our client's regulatory affairs team remotely. You will create clear, accurate medical writing for CSR, IBs, CTD modules, and regulatory submissions, ensuring compliance with ICH, FDA, EMA, and SAHPRA.

You will collaborate with R&D, regulatory, and clinical teams while working from home. Candidates should hold a life science degree (BSc or MSc) and have at least 3 years of pharma/biotech medical writing experience, with proven CSR