Senior Medical Writer

Placements24; Randburg; Hybrid; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Competitive salary package

Health insurance

Generous paid time off

Remote work options

Professional development

Job summary

Placements24 is seeking a Senior Medical Writer to join its dynamic medical affairs team. This role is remote and offers flexibility for talented writers to produce regulatory and clinical documents supporting product development and submissions for global markets.

You will create CSRs, Investigator's Brochures, CTDs, and briefing documents, ensure compliance with ICH and GCP guidelines, and collaborate across clinical operations, regulatory affairs, statistics, and R&D to ensure timely,

Qualifications

• Master's or Ph.D. in a life science, pharmacy, or related discipline.
• Minimum of 5 years of experience as a Medical Writer in the pharmaceutical/biotech industry.
• Proven expertise in writing regulatory and clinical documents.
• Thorough understanding of drug development processes and GCP.
• Excellent written and verbal communication, with meticulous attention to detail.

Responsibilities

• Write, edit, and review regulatory and medical documents (CSRs, Investigator's Brochures).
• Prepare documents for regulatory submissions (CTDs, briefing documents).
• Ensure scientific accuracy and adherence to guidelines (ICH, GCP).
• Collaborate with cross-functional teams (clinical ops, regulatory affairs, statistics, R&D).
• Manage multiple projects to deliver on time and within quality standards.
• Stay updated on industry trends and regulatory changes.

Skills

Medical writing

Regulatory writing

ICH guidelines

Remote collaboration

Project management

Education

MSc/PhD in life sciences

Job description

About the Role

Our client is seeking a highly skilled and experienced Senior Medical Writer to join their dynamic medical affairs team. This role can be performed remotely, offering flexibility to talented writers. You will be responsible for producing clear, concise, and scientifically accurate regulatory and medical documents to support product development and regulatory submissions. This includes clinical study reports, Investigator's Brochures, regulatory submission documents, and publications. The ideal candidate possesses exceptional writing skills, a deep understanding of pharmaceutical research and development, and the ability to manage multiple projects efficiently, ensuring timely delivery of high-quality documentation for the Gauteng province and global markets.

Key Responsibilities

• Write, edit, and review a variety of complex medical and regulatory documents, including clinical study protocols, Clinical Study Reports (CSRs), and Investigator's Brochures.
• Prepare documents for regulatory submissions, such as Common Technical Documents (CTDs) and briefing documents for health authorities.
• Ensure all documents are scientifically accurate, adhere to relevant guidelines (e.g., ICH), and meet regulatory requirements.
• Collaborate effectively with cross-functional teams, including clinical operations, regulatory affairs, statistics, and R&D.
• Manage multiple projects simultaneously, ensuring timely completion of deliverables.
• Stay abreast of industry trends, regulatory changes, and best practices in medical writing.

Requirements

• Master's or Ph.D. in a life science, pharmacy, or related discipline.
• Minimum of 5 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
• Proven expertise in writing various types of regulatory and clinical documents.
• Thorough understanding of drug development processes and Good Clinical Practice (GCP).
• Exceptional written and verbal communication skills, with meticulous attention to detail.
• Ability to work independently and manage projects effectively in a remote setting.

Benefits

• Competitive salary and performance-based bonus structure.
• Comprehensive health, dental, and vision insurance coverage.
• Generous paid time off and flexible remote work options.
• Opportunities for professional development and continuing education.
• A collaborative environment that values scientific integrity and impactful communication.