Medical Writer - Regulatory Documentation

Placements24; Paarl; Hybrid; ZAR 480,000 - 600,000; Full time

Benefits offered by this job

Competitive salary

Medical coverage

Paid time off

Flexible hours

Remote-friendly work

Job summary

Placements24 seeks a skilled Medical Writer to produce regulatory documents for pharmaceutical products from Paarl. You will author, edit, and review clinical study reports, regulatory submission documents, and CTD modules with clarity and scientific rigor.

The role requires a life sciences degree and a minimum of 3 years’ regulatory writing experience, with the ability to translate complex data into concise text while meeting tight deadlines in a collaborative, remote-friendly environment.

Qualifications

• Bachelor's degree in a scientific discipline (Life Sciences, Pharmacy, Medicine).
• Minimum of 3 years of experience as a Medical Writer in pharmaceutical/biotech with focus on regulatory documentation.
• Proven ability to write clear, concise, scientifically accurate documents for diverse audiences.
• Strong understanding of clinical trial processes, pharmaceutical development, and regulatory requirements.
• Proficiency in standard office software and document management systems.
• Excellent organizational skills and ability to manage multiple projects under tight deadlines.

Responsibilities

• Author, edit, and finalize regulatory documents such as CSRs and CTD modules.
• Ensure documents are scientifically accurate and adhere to guidelines.
• Collaborate with cross-functional teams to gather information for submissions.
• Review and revise documents based on stakeholder feedback.
• Maintain knowledge of regulatory guidelines and best practices.

Skills

Regulatory writing

Scientific writing

Attention to detail

Education

Bachelor's degree in Life Sciences/Pharmacy/Medicine

Job description

About the Role

Our client is seeking a skilled and experienced Medical Writer to produce high-quality regulatory documentation for their pharmaceutical products from their base in Paarl. You will be responsible for authoring, editing, and reviewing a variety of documents, including clinical study reports, regulatory submission documents, and scientific publications. This role demands exceptional writing abilities, a thorough understanding of scientific principles, and the capacity to translate complex data into clear, concise, and compliant text.

Key Responsibilities

• Author, edit, and finalize various regulatory documents, such as clinical trial protocols, Investigator's Brochures (IBs), Clinical Study Reports (CSRs), and Common Technical Document (CTD) modules.
• Ensure all documents are scientifically accurate, grammatically correct, and adhere to company style guides and relevant regulatory agency guidelines.
• Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and statistics, to gather information and ensure document completeness.
• Review and revise documents based on internal and external stakeholder feedback.
• Maintain knowledge of therapeutic areas, relevant guidelines, and industry best practices for medical and regulatory writing.
• Manage document timelines and deliverables effectively to meet submission deadlines.

Requirements

• Bachelor's degree in a scientific discipline (e.g., Life Sciences, Pharmacy, Medicine). A Master's or Ph.D. is an asset.
• Minimum of 3 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry, with a focus on regulatory documentation.
• Proven ability to write clear, concise, and scientifically accurate documents for diverse audiences.
• Strong understanding of clinical trial processes, pharmaceutical development, and regulatory requirements.
• Proficiency in standard office software and experience with document management systems.
• Excellent organizational skills and the ability to manage multiple projects under tight deadlines.

Benefits

• Competitive salary with potential for performance-based increases.
• Comprehensive medical, dental, and vision coverage.
• Generous paid time off and flexible working hours.
• Opportunities for professional growth and training in medical writing.
• A supportive and collaborative remote working environment.