Remote Medical Writer

Placements24; Paarl; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Health, dental, and vision insurance

Home office setup allowance

Flexible working hours

Professional development opportunities

Job summary

Placements24 is seeking a talented Remote Medical Writer to craft clinical study reports, regulatory submissions, investigator brochures, and publications from a home office. The role involves collaboration with R&D, clinical operations, and regulatory affairs to ensure high-quality, regulatory-compliant documents.

The ideal candidate has 5+ years of medical writing experience in pharma/biotech and a strong grasp of ICH guidelines, with excellent writing and project management skills for a fully

Qualifications

• Bachelor’s or Master’s degree in life science, medical field, English, or related discipline.
• Minimum of 5 years of experience as a Medical Writer in pharma/biotech/medical device.
• Demonstrated expertise in writing clinical and regulatory documents.
• Thorough understanding of drug development processes and regulatory guidelines (ICH, FDA, EMA).
• Exceptional written and verbal communication with meticulous attention to detail.
• Proven ability to work independently and manage projects remotely.

Responsibilities

• Author, edit, and review medical documents including CSRs and manuscripts for publication.
• Prepare regulatory submission documents (INDs, NDAs).
• Ensure content is scientifically accurate and adheres to style guides and regulatory guidelines (ICH).
• Collaborate with SMEs to gather information and ensure document accuracy.
• Manage multiple writing projects with tight deadlines in a remote setting.
• Contribute to templates and processes to improve efficiency and quality.

Education

Bachelor’s or Master’s in life science / medical field / English or related discipline

Job description

About the Role

Our client is seeking a talented and experienced Remote Medical Writer to craft clear, accurate, and compliant scientific and regulatory documents. In this fully remote role, you will be responsible for developing a wide range of essential documents, including clinical study reports, regulatory submissions, investigator brochures, and publications. You will collaborate closely with R&D, clinical operations, and regulatory affairs teams to ensure all content meets stringent quality standards and regulatory requirements. This is an exceptional opportunity for a skilled writer to contribute significantly to pharmaceutical development from the comfort of their home office. The ideal candidate possesses exceptional writing skills and a strong understanding of pharmaceutical research and development.

Key Responsibilities

• Author, edit, and review various medical documents , including clinical protocols, clinical study reports (CSRs), and manuscripts for publication.
• Prepare and manage regulatory submission documents, such as Investigational New Drug (IND) applications and New Drug Applications (NDAs).
• Ensure all written content is scientifically accurate, grammatically correct, and adheres to relevant style guides and regulatory guidelines (e.g., ICH).
• Collaborate effectively with subject matter experts (SMEs) from diverse scientific and clinical backgrounds to gather information and ensure document accuracy.
• Manage multiple writing projects simultaneously, meeting tight deadlines in a remote work environment.
• Contribute to the development of templates and processes to improve the efficiency and quality of medical writing operations.

Requirements

• Bachelor's or Master's degree in a life science, medical field, English, or a related discipline.
• Minimum of 5 years of experience as a Medical Writer in the pharmaceutical, biotechnology, or medical device industry.
• Demonstrated expertise in writing various types of clinical and regulatory documents.
• Thorough understanding of drug development processes and regulatory guidelines (e.g., ICH, FDA, EMA).
• Exceptional written and verbal communication skills, with meticulous attention to detail.
• Proven ability to work independently and manage projects effectively in a remote setting.

Benefits

• Highly competitive annual salary, commensurate with experience.
• Comprehensive health, dental, and vision insurance coverage.
• Generous home office setup allowance and technology support.
• Flexible working hours to promote work-life balance.
• Continuous professional development and opportunities to expand your writing portfolio in a remote capacity.