Medical Writer - Clinical Documentation

Placements24; United States; Remote; USD 22,000 - 29,000; Full time

Benefits offered by this job

Fully remote work

Flexible hours

Diverse projects

Job summary

Placements24 partners with a leading pharmaceutical research organization to hire a Medical Writer on a contract basis. This remote role is open to candidates located anywhere in South Africa who can collaborate with global teams on regulatory documents.

You will write, edit, and review clinical study protocols, investigator brochures, and CSRs, ensuring ICH compliance, clarity, and accuracy, while managing timelines and templates.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, or related field.
• Minimum of 3 years as a Medical Writer in pharma/biotech.
• Experience writing protocols, investigator brochures and CSRs.
• Strong knowledge of ICH guidelines and regulatory requirements.
• Excellent writing, editing and proofreading skills; detail-oriented.

Responsibilities

• Write, edit, and review clinical documents for regulatory submissions.
• Ensure documents are scientifically accurate and compliant with ICH.
• Collaborate with SMEs to gather information and ensure accuracy.
• Manage timelines and deliverables for writing projects.
• Maintain consistency in style, tone, and terminology across documents.

Skills

Medical writing

Regulatory writing

Editing

ICH guidelines

Remote collaboration

Education

Bachelor's degree in Life Sciences

Master's degree in Life Sciences

Tools

Microsoft Word

Document management systems

Job description

About the Role

Our client, a leading pharmaceutical research organization, is seeking a skilled and experienced Medical Writer to join their team on a contract basis. This role is responsible for preparing high-quality clinical documentation for regulatory submissions, publications, and internal use. The Medical Writer will work remotely, collaborating with clinical development, regulatory affairs, and project management teams to ensure clarity, accuracy, and compliance of all written materials. This is an excellent opportunity for a detail-oriented writer with a strong scientific background to contribute to critical drug development processes from anywhere in South Africa. We value clear, concise, and scientifically accurate communication to facilitate regulatory approvals and disseminate vital research findings.

Key Responsibilities

• Write, edit, and review various clinical documents, including clinical study protocols, investigator brochures, clinical study reports (CSRs), and regulatory submission documents.
• Ensure all documentation is scientifically accurate, clear, concise, and adheres to relevant regulatory guidelines (e.g., ICH).
• Collaborate with subject matter experts (SMEs) to gather information and ensure the accuracy of documents.
• Manage timelines and deliverables for assigned writing projects.
• Participate in cross-functional team meetings to discuss document content and strategy.
• Maintain consistency in style, tone, and terminology across all documents.
• Contribute to the development and refinement of document templates and style guides.
• Review and respond to comments from internal and external reviewers.
• Ensure compliance with company policies and SOPs related to medical writing.

Requirements

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Medicine, or a related field.
• Minimum of 3 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
• Proven experience in writing clinical study protocols, investigator brochures, and clinical study reports.
• Strong understanding of ICH guidelines and regulatory requirements for clinical documentation.
• Exceptional writing, editing, and proofreading skills, with a keen eye for detail.
• Ability to interpret complex scientific and clinical data.
• Proficiency in Microsoft Word and experience with document management systems.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively in a remote team environment.
• Must be based in South Africa and authorized to work as a contractor.

Benefits

• Competitive contract rate, translating to an annual equivalent salary of R .
• Fully remote work arrangement, providing flexibility and autonomy.
• Opportunity to work on diverse and impactful clinical projects.
• Flexible working hours.
• Gain experience with a reputable pharmaceutical organization.
• Contribute to the advancement of global health.