Senior Medical Writer

Placements24; Mbombela (Nelspruit); On-site; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Competitive salary

Professional development

Annual bonuses

Generous paid time off

Retirement fund

Job summary

Placements24 is seeking a Senior Medical Writer to join the regulatory affairs and medical communications team in Nelspruit, Mpumalanga. You will craft clear, compliant clinical and regulatory documents to support global drug development and registration.

The role requires extensive experience with CSRs, CTD modules, IBs, and regulatory submissions, plus strong English communication and meticulous scientific accuracy. Collaboration with cross-functional teams is essential.

Qualifications

• Bachelor's or Master's in life science, pharmaceutical science, communications, or related field.
• PhD is advantageous.
• Minimum of 6 years' experience as a medical writer in pharma/biotech or CRO.

Responsibilities

• Write, edit, and review complex clinical and regulatory documents for health authorities.
• Develop CSRs in line with ICH guidelines and company standards.
• Prepare CTD module content and regulatory submission dossiers.
• Create IBs, informed consent forms, and related study documents.
• Collaborate with investigators, statisticians, data managers, and regulatory experts.
• Translate complex data into clear, scientifically sound narratives.
• Ensure documents follow style guides and regulatory compliance.
• Manage multiple writing projects and ensure timely delivery.
• Review documents written by others and stay updated on guidelines.

Skills

Medical writing

Regulatory submissions

ICH guidelines

Project management

English proficiency

Education

Bachelor's or Master's in life science

Ph.D. advantageous

Tools

Microsoft Word

Document management systems

Job description

About the Role

Our client, a highly respected pharmaceutical company, is seeking an experienced Senior Medical Writer to join their dedicated regulatory affairs and medical communications team in Nelspruit, Mpumalanga . This pivotal role involves crafting clear, accurate, and compliant scientific and regulatory documents that support drug development and registration worldwide. You will be responsible for developing a wide range of documents, including clinical study reports (CSRs), regulatory submission dossiers (e.g., CTD modules), investigator brochures, and manuscripts for publication. The ideal candidate possesses exceptional writing skills, a strong understanding of clinical research, and a meticulous approach to scientific accuracy and regulatory compliance. This is an excellent opportunity to contribute to bringing essential medicines to patients by ensuring high-quality documentation that meets global standards. We foster a collaborative environment focused on scientific integrity and communication excellence.

Key Responsibilities

• Write, edit, and review complex clinical and regulatory documents for submission to health authorities globally.
• Develop Clinical Study Reports (CSRs) in accordance with ICH guidelines and company standards.
• Prepare and manage the content for various sections of regulatory submission dossiers, including Common Technical Document (CTD) modules.
• Create Investigator's Brochures (IBs), informed consent forms, and other essential study-related documents.
• Collaborate closely with clinical investigators, statisticians, data managers, regulatory specialists, and other subject matter experts to ensure the accuracy and completeness of documents.
• Translate complex scientific and clinical data into clear, concise, and scientifically sound narratives.
• Ensure all documents adhere to company style guides, regulatory requirements, and good scientific writing practices.
• Manage multiple writing projects simultaneously, ensuring timely delivery and adherence to project timelines.
• Review and revise documents written by other medical writers or subject matter experts.
• Stay current with evolving regulatory guidelines and industry best practices for medical writing.
• Contribute to the development and maintenance of medical writing templates and standard operating procedures (SOPs).

Requirements

• Bachelor's or Master's degree in a life science, pharmaceutical science, communications, or related field.
• A Ph.D. is advantageous.
• A minimum of 6 years of experience as a medical writer in the pharmaceutical or biotechnology industry, or at a Contract Research Organization (CRO).
• Demonstrated expertise in writing various types of clinical and regulatory documents, particularly CSRs and regulatory submission components.
• Thorough understanding of ICH guidelines (especially E3 for CSRs) and global regulatory submission requirements.
• Exceptional written and verbal communication skills, with a strong command of English grammar and scientific terminology.
• Meticulous attention to detail and a commitment to scientific accuracy.
• Ability to interpret and synthesize complex data from clinical trials and other sources.
• Strong project management and organizational skills, with the ability to manage competing priorities.
• Proficiency in Microsoft Office Suite, particularly Word.
• Experience with document management systems is a plus.
• Ability to work effectively both independently and collaboratively within a multidisciplinary team.
• Experience in specific therapeutic areas may be beneficial.

Benefits

• Competitive salary and comprehensive benefits package.
• Opportunities for professional growth and development within a leading pharmaceutical company.
• Exposure to diverse therapeutic areas and cutting-edge drug development projects.
• A collaborative and supportive team environment in Nelspruit .
• Annual performance bonuses.
• Support for continuing education and professional development.
• Generous paid time off and holiday schedule.
• Contribution to retirement fund.