Medical Writer - Pharmaceutical Development

Placements24; Upington; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Flexible hybrid work model

Comprehensive benefits package

Professional development opportunities

Job summary

Placements24 is seeking a skilled Medical Writer specializing in Pharmaceutical Development to support regulatory and scientific documents for drug development, potentially based in Upington. The role offers a hybrid work arrangement with on-site collaboration.

You will author CSRs, IBs, protocols, and study summaries, ensure compliance with ICH guidelines and company standards, and collaborate with cross-functional teams to meet milestones.

Qualifications

• Bachelor's or Master's in life science, pharmacy, or related field.
• Minimum 3 years as Medical Writer in the pharmaceutical/biotech industry.
• Clear, concise, scientifically accurate writing.
• Strong knowledge of ICH guidelines and regulatory submissions.

Responsibilities

• Author, edit, and review CSRs, IBs, protocols, and study summaries.
• Ensure documents meet ICH and company guidelines.
• Collaborate with cross-functional teams to gather information.
• Manage multiple writing projects with tight timelines.
• Develop and maintain document templates and style guides.
• Stay updated on regulatory guidelines affecting medical writing.

Skills

Medical writing

Regulatory writing

Cross-functional collaboration

Education

Bachelor's or Master's degree in life science or pharmacy

Tools

Microsoft Office Suite

Document management systems

Job description

About the Role

Our client is seeking a skilled and experienced Medical Writer specializing in Pharmaceutical Development to support their operations, potentially based in or near Upington . You will be responsible for creating clear, accurate, and compliant regulatory and scientific documents essential for drug development and submission. This includes clinical study reports, investigator brochures, and regulatory submission documents. This role offers a hybrid work arrangement, allowing for focused remote work on documentation while maintaining essential on-site collaboration. You will play a critical role in translating complex scientific and clinical data into well-structured documents that meet global regulatory standards.

Key Responsibilities

• Author, edit, and review various types of regulatory and scientific documents, including Clinical Study Reports (CSRs), Investigator Brochures (IBs), protocols, and study summaries.
• Ensure all documents are prepared in accordance with company guidelines, regulatory requirements (e.g., ICH), and good documentation practices.
• Collaborate effectively with cross-functional teams, including clinical operations, regulatory affairs, biostatistics, and project management, to gather information and ensure document accuracy.
• Manage multiple writing projects simultaneously, adhering to strict timelines and project milestones.
• Contribute to the development and maintenance of document templates and style guides.
• Stay updated on relevant therapeutic areas, scientific advancements, and regulatory guidelines impacting medical writing.

Requirements

• Bachelor's or Master's degree in a life science, pharmacy, or related scientific field.
• Minimum of 3 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
• Proven ability to write clear, concise, and scientifically accurate documents.
• Thorough understanding of ICH guidelines and regulatory submission requirements for pharmaceutical products.
• Proficiency with Microsoft Office Suite and experience with document management systems.
• Excellent organizational, time management, and interpersonal skills.

Benefits

• Competitive salary and comprehensive benefits package.
• Opportunities for professional development and training in medical writing and regulatory affairs.
• Be part of a dynamic team contributing to the advancement of pharmaceutical products.
• A flexible hybrid work model that supports both remote productivity and essential team interaction.
• Contribute to critical documentation that supports global drug approvals.