Medical Writer - Regulatory Documents

Placements24; Noord-Kaap; On-site; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Medical insurance

Retirement plan

Paid time off

Professional development

Job summary

Placements24 in Kimberley, South Africa, is seeking a skilled Medical Writer to craft regulatory and clinical documents for pharmaceutical products. You will ensure clarity, accuracy, and regulatory compliance in submissions to authorities worldwide, working with R&D, clinical operations, and regulatory affairs.

The role requires a life sciences degree, at least 3 years in medical writing, and experience with CSRs, protocols, and submission documents.

Qualifications

• Bachelor's degree in a life science, healthcare, or related field; advanced degree preferred.
• Minimum of 3 years of experience as a Medical Writer in the pharmaceutical/biotech industry.
• Experience in writing regulatory and clinical documents (e.g., CSRs, protocols, submission documents).
• Strong understanding of ICH guidelines and regulatory submission requirements.
• Exceptional writing, editing, and proofreading skills with meticulous attention to detail.
• Ability to work with cross-functional teams in a Kimberley-based environment.

Responsibilities

• Write, edit, and review regulatory documents including CSRs, IBs, protocols, and submission documents.
• Ensure documents are scientifically accurate, properly formatted, and compliant with regulatory guidelines.
• Collaborate with subject matter experts to gather information and ensure technical accuracy.
• Manage document timelines and deliverables in coordination with project teams.
• Maintain up-to-date knowledge of regulatory guidelines and industry best practices.
• Contribute to the development and improvement of document templates and writing standards.

Skills

Medical writing

Regulatory writing

ICH guidelines

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

About the Role

Our client is seeking a skilled and precise Medical Writer to craft essential regulatory and clinical documents for their pharmaceutical products based in Kimberley . This role is pivotal in ensuring clear, accurate, and compliant communication of scientific and medical information to regulatory agencies and stakeholders worldwide. You will collaborate with cross-functional teams, including R&D, clinical operations, and regulatory affairs, to produce high-quality documents that support drug development and approval processes. This is an excellent opportunity to contribute to critical documentation within the pharmaceutical sector from our Kimberley office.

Key Responsibilities

• Write, edit, and review a variety of regulatory documents, including clinical study protocols, clinical study reports (CSRs), Investigator's Brochures (IBs), and IND/NDA/MAA submissions.
• Ensure all documents are scientifically accurate, adhere to required formats, and comply with regulatory guidelines.
• Collaborate with subject matter experts to gather information and ensure technical accuracy.
• Manage document timelines and deliverables in coordination with project teams.
• Maintain up-to-date knowledge of regulatory guidelines and industry best practices for medical writing.
• Contribute to the development and improvement of document templates and writing standards.

Requirements

• Bachelor's degree in a life science, healthcare, or related field; advanced degree preferred.
• Minimum of 3 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
• Demonstrated experience in writing key regulatory and clinical documents (e.g., CSRs, protocols, submission documents).
• Thorough understanding of ICH guidelines and regulatory submission requirements.
• Exceptional writing, editing, and proofreading skills with meticulous attention to detail.
• Ability to work effectively with cross-functional teams and manage multiple projects in a Kimberley -based environment.

Benefits

• Competitive salary and performance-based incentives.
• Comprehensive medical insurance and retirement plan.
• Paid time off and holiday leave.
• Professional development opportunities and training programs.
• A collaborative work environment focused on producing impactful scientific documentation.