Senior Medical Writer - Pharmaceutical

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

About the Role

Our client, a globally recognized pharmaceutical research organization, is seeking an accomplished Senior Medical Writer to join their dedicated team. This is a fully remote position, allowing you to contribute your expertise from anywhere. You will be responsible for the preparation of high-quality regulatory documents, clinical study reports, and other essential scientific communications that support drug development and regulatory submissions. The role requires a deep understanding of medical terminology, clinical research processes, and regulatory requirements across different global health authorities. As a Senior Medical Writer, you will play a vital role in clearly and accurately conveying complex scientific data to diverse audiences, ensuring compliance and clarity. This is an exceptional opportunity to advance your career in medical communications within a leading organization committed to improving global health.

Key Responsibilities

• Author, edit, and finalize a variety of complex regulatory and scientific documents, including Clinical Study Reports (CSRs), Investigational New Drug (IND) applications, New Drug Applications (NDAs), and briefing documents.
• Ensure all written materials are scientifically accurate, clearly written, and compliant with relevant regulatory guidelines (e.g., ICH, FDA, EMA).
• Collaborate effectively with cross-functional teams, including clinical operations, biostatistics, regulatory affairs, and medical affairs, to gather information and ensure document accuracy.
• Manage document development timelines and workflows to meet submission deadlines.
• Review and edit documents authored by other writers or team members.
• Maintain a thorough understanding of therapeutic areas and the drug development process.
• Contribute to the development and maintenance of templates and style guides for regulatory documentation.
• Participate in relevant project team meetings and contribute scientific writing expertise.
• Stay abreast of industry best practices and evolving regulatory requirements for medical writing.
• Mentor junior medical writers and provide guidance on best practices.

Requirements

• Bachelor's degree in a life science, health science, English, or related field; Master's or Ph.D. preferred.
• Minimum of 5 years of experience as a Medical Writer in the pharmaceutical, biotechnology, or medical device industry.
• Demonstrated expertise in writing complex regulatory documents (e.g., CSRs, CTD modules).
• Strong understanding of clinical trial design, data analysis, and pharmaceutical regulatory guidelines.
• Exceptional written and verbal communication skills, with a meticulous attention to detail.
• Ability to interpret complex scientific and statistical data.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Experience with document management systems is a plus.
• Ability to work independently and manage multiple projects in a remote environment.
• Must be based in or able to work remotely from Polokwane, Limpopo, ZA

Benefits

• Annual salary of R .
• Comprehensive health insurance plan.
• Generous paid vacation and sick leave.
• Retirement savings plan.
• Opportunities for professional development and conference attendance.
• Fully remote work setup with provided equipment.
• Supportive and collaborative team culture.