Remote Senior Medical Writer - Regulatory Docs & CSR Expert

Placements24; South Africa; Remote; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Comprehensive health insurance plan

Generous paid vacation and sick leave

Retirement savings plan

Opportunities for professional develop

Fully remote work setup with provided

Supportive and collaborative team

Job summary

Placements24 seeks a Senior Medical Writer for a fully remote role with a globally recognized pharmaceutical research organization. You will prepare regulatory documents, CSRs, INDs, NDAs and other scientific communications to support drug development and regulatory submissions.

You will collaborate with cross-functional teams, ensure regulatory compliance (ICH, FDA, EMA), mentor junior writers, and stay current with evolving guidelines.

Qualifications

• Bachelor's degree in life sciences or related field; Master's or PhD preferred.
• Minimum of 5 years of medical writing experience in pharma/biotech/medical device.
• Proven expertise in regulatory documents (CSRs, CTD modules).
• Strong understanding of clinical trial design, data analysis, and regulatory guidelines.
• Excellent written and verbal communication with meticulous attention to detail.
• Ability to interpret complex data and work independently in a remote setting.

Responsibilities

• Author, edit, and finalize CSR, IND, NDA and briefing documents.
• Ensure materials are accurate and compliant with ICH, FDA, EMA.
• Collaborate with cross-functional teams to gather information and ensure accuracy.
• Manage development timelines and submission deadlines.
• Review documents written by others.
• Maintain understanding of therapeutic areas and drug development.
• Contribute to templates and style guides for regulatory documents.
• Participate in project meetings and provide scientific writing expertise.
• Stay updated on evolving regulatory requirements for medical writing.
• Mentor junior writers.

Skills

Medical writing

Regulatory documents

CSR/CTD familiarity

Clinical trial design understanding

Regulatory guidelines knowledge

Attention to detail

Education

Bachelor's degree in life sciences

Master's or PhD preferred

Tools

MS Word

Excel

PowerPoint

Job description

Placements24 seeks a Senior Medical Writer for a fully remote role with a globally recognized pharmaceutical research organization. You will prepare regulatory documents, CSRs, INDs, NDAs and other scientific communications to support drug development and regulatory submissions.

You will collaborate with cross-functional teams, ensure regulatory compliance (ICH, FDA, EMA), mentor junior writers, and stay current with evolving guidelines.