Remote Principal Medical Writer

Placements24; Pretoria; Hybrid; ZAR 1,500,000 - 2,000,000; Full time

Benefits offered by this job

Fully remote

Medical insurance

Dental insurance

Vision insurance

Generous vacation

Professional development

Job summary

Placements24 is seeking a Principal Medical Writer to lead the development of regulatory documents from home within South Africa. You will mentor junior writers and drive high-quality submissions across INDs, NDAs, and CTDs.

Responsibilities include coordinating cross-functional teams, ensuring scientific accuracy, and maintaining global regulatory standards. A Master’s or PhD in life sciences and 8–10 years of pharma experience are required.

Qualifications

• Master's degree or PhD in life science or related field.
• 8–10 years' medical writing experience in pharma/biotech focusing on regulatory documents.
• Proven ability to write regulatory submission documents (INDs, NDAs, CTDs).
• Strong knowledge of ICH guidelines and global submission requirements.
• Excellent writing, editing, proofreading, and attention to detail.
• Ability to interpret and synthesize complex data.
• Strong project management and ability to meet deadlines.
• Excellent communication, remote collaboration.
• MS Office and document management familiarity.

Responsibilities

• Lead the preparation of regulatory documents (IBs, protocols, CSRs, CTDs).
• Ensure documents are scientifically accurate and compliant with guidelines.
• Collaborate with cross-functional teams in regulatory affairs and development.
• Review and edit documents authored by teammates.
• Contribute to internal style guides and templates.
• Manage multiple projects with timely delivery.

Skills

Regulatory writing

Clinical data interpretation

Document management

Education

Master's degree

PhD

Tools

MS Office

Document management systems

Job description

About the Role

Our client, a globally recognized pharmaceutical leader, is actively seeking an accomplished Principal Medical Writer to join their highly collaborative and innovative regulatory affairs department. This is a completely remote position, allowing you to contribute to our client's mission from the comfort of your own home office anywhere in South Africa. You will be responsible for the development of high-quality, scientifically accurate regulatory documents for submission to health authorities worldwide. This role requires exceptional writing skills, a comprehensive understanding of regulatory requirements, and the ability to interpret complex scientific and clinical data. As a Principal Medical Writer, you will also play a key role in mentoring junior writers and contributing to the continuous improvement of our client's medical writing processes. This remote opportunity offers the chance to work on diverse and impactful projects, advancing global healthcare solutions.

Key Responsibilities

• Lead the preparation of a wide range of complex regulatory documents, including Investigator's Brochures, Clinical Study Protocols, Clinical Study Reports (CSRs), Common Technical Document (CTD) modules, and responses to regulatory agencies.
• Ensure all documents are scientifically accurate, clear, concise, and compliant with relevant guidelines and regulatory standards.
• Collaborate effectively with cross-functional teams, including clinical development, regulatory affairs, biostatistics, and project management.
• Review and edit documents authored by other medical writers and team members.
• Contribute to the development and refinement of internal style guides and templates.
• Manage multiple projects simultaneously, ensuring timely delivery of high-quality documents.
• Stay current with evolving regulatory landscapes and industry best practices in medical writing.
• Provide guidance and mentorship to junior medical writers.

Requirements

• Master's degree or PhD in a life science, pharmaceutical science, or related discipline.
• Minimum of 8-10 years of experience as a medical writer in the pharmaceutical or biotechnology industry, with a significant focus on regulatory documents.
• Demonstrated expertise in writing complex regulatory submission documents (e.g., INDs, NDAs, BLAs, CTDs).
• Thorough understanding of ICH guidelines and global regulatory submission requirements.
• Exceptional writing, editing, and proofreading skills, with a keen eye for detail.
• Proven ability to interpret and synthesize complex scientific and clinical data.
• Strong project management and organizational skills, with the ability to meet tight deadlines.
• Excellent communication and interpersonal skills, capable of working effectively with diverse teams in a remote setting.
• Proficiency in Microsoft Office Suite and familiarity with document management systems.

Benefits

• Fully remote work arrangement with geographical flexibility within South Africa.
• Highly competitive salary and potential for bonuses.
• Comprehensive benefits package including medical, dental, and vision insurance.
• Generous vacation and paid time off.
• Support for professional development, conferences, and training.
• Opportunity to work on innovative drug development programs.
• A supportive and intellectually stimulating remote work environment.