Remote Senior Medical Writer: CSRs & Regulatory Submissions

Placements24; Polokwane; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Competitive salary

Health/dental/vision insurance

Retirement plan with company match

Paid time off

Home office stipend

Professional growth opportunities

Flexible remote work

International team environment

Job summary

Placements24 is seeking a Senior Medical Writer to join a fully remote team. The role involves authoring CSRs, protocols, and regulatory documents for a portfolio of pharmaceutical products, with collaboration across clinical operations, biostatistics, and regulatory affairs.

The ideal candidate has 5+ years in medical writing, deep knowledge of ICH-GCP, and exceptional writing and editing skills. This position offers remote flexibility, international collaboration, and opportunities to

Qualifications

• Bachelor's or Master's degree in a life science, medical, or related field.
• Minimum of 5 years of experience as a Medical Writer in pharma/biotech.
• Proven expertise in authoring clinical study reports (CSRs).
• Strong knowledge of ICH-GCP and regulatory submission requirements.
• Excellent writing, editing, and proofreading skills.
• Ability to interpret complex data and work remotely.

Responsibilities

• Author and edit clinical study reports (CSRs) according to ICH guidelines and company standards.
• Develop clinical trial protocols, investigator brochures, and other essential regulatory documents.
• Ensure scientific accuracy, clarity, and consistency in all written documentation.
• Collaborate effectively with clinical operations, biostatistics, regulatory affairs, and project management teams.
• Manage multiple writing projects simultaneously, adhering to strict deadlines.
• Review and revise documents based on internal and external feedback.
• Stay current with relevant guidelines (ICH, FDA, EMA) and therapeutic areas.
• Contribute to the development of style guides and templates for medical writing.
• Mentor and guide junior medical writers as needed.

Skills

Medical writing

Regulatory writing

CSR writing

Editing

Remote collaboration

Education

Bachelor's/Master's in life sciences

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Placements24 is seeking a Senior Medical Writer to join a fully remote team. The role involves authoring CSRs, protocols, and regulatory documents for a portfolio of pharmaceutical products, with collaboration across clinical operations, biostatistics, and regulatory affairs.

The ideal candidate has 5+ years in medical writing, deep knowledge of ICH-GCP, and exceptional writing and editing skills. This position offers remote flexibility, international collaboration, and opportunities to