Senior Medical Writer - Regulatory Submissions

Placements24; Stellenbosch; On-site; ZAR 1,000,000 - 1,500,000; Full time

Benefits offered by this job

Competitive salary

Medical, dental, and vision insurance

Relocation assistance

Professional development opportunities

Job summary

Placements24 seeks a Senior Medical Writer for its regulatory affairs department in Stellenbosch, Western Cape. The role focuses on planning, writing, editing, and reviewing regulatory documents essential for drug approval and post-marketing activities.

The candidate will collaborate with R&D, clinical, and regulatory teams to ensure accuracy, clarity, and compliance with global standards. Leadership and mentoring duties are included.

Qualifications

• Master's degree or Ph.D. in a Life Science, Pharmacy, or related discipline.
• Minimum of 5 years of experience in medical writing within pharma/biotech.
• Proven track record of authoring complex regulatory documents for global submissions.
• Understanding of drug development and global regulatory requirements (US, EU).
• Exceptional written and verbal communication, detail-oriented.

Responsibilities

• Author, edit, and review regulatory submission documents (INDs, NDAs, CTDs, PSURs).
• Ensure scientific accuracy and regulatory compliance across guidelines (ICH, FDA, EMA).
• Collaborate with SMEs to gather content and ensure accuracy.
• Manage document timelines and project plans to meet deadlines.
• Mentor junior medical writers and contribute to templates, style guides, and SOPs.

Skills

Regulatory submissions

Document management

Cross-functional collaboration

Education

Master's degree or PhD in Life Science/Pharmacy

Tools

Regulatory submission software

Document management systems

Job description

About the Role

Our client, a distinguished pharmaceutical company renowned for its commitment to advancing global health, is seeking a highly skilled Senior Medical Writer to bolster their regulatory affairs department. This pivotal role involves the planning, writing, editing, and review of a wide range of high-quality regulatory documents essential for drug approval and post-marketing activities. You will collaborate closely with R&D, clinical, and regulatory teams to ensure scientific accuracy, clarity, and compliance with global regulatory standards. The position is based in our vibrant hub in Stellenbosch, Western Cape, offering a stimulating professional environment. We are dedicated to fostering a culture of scientific excellence and collaboration. This role is critical for the successful submission and approval of new and existing pharmaceutical products.

Key Responsibilities

• Author, edit, and review key regulatory submission documents, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Common Technical Documents (CTDs), and Periodic Safety Update Reports (PSURs).
• Ensure all documents are scientifically accurate, clinically sound, and compliant with relevant guidelines (e.g., ICH, FDA, EMA).
• Collaborate with subject matter experts (SMEs) from various disciplines to gather information and ensure accuracy of content.
• Manage document timelines and project plans to meet submission deadlines.
• Contribute to the development of departmental templates, style guides, and SOPs for medical writing.
• Review and interpret clinical study reports (CSRs), non-clinical study reports, and other relevant data.
• Stay updated on evolving regulatory requirements and industry best practices in medical writing.
• Ensure consistency in messaging and terminology across all regulatory documents.
• Act as a key point of contact for regulatory agencies regarding documentation queries.
• Mentor junior medical writers and provide guidance on best practices.

Requirements

• Master's degree or Ph.D. in a Life Science, Pharmacy, or related scientific discipline.
• Minimum of 5 years of experience in medical writing, specifically within the pharmaceutical or biotechnology industry, with a focus on regulatory submissions.
• Proven track record of authoring complex regulatory documents for global submissions.
• In-depth understanding of drug development processes and regulatory requirements in major markets (US, EU, etc.).
• Exceptional written and verbal communication skills, with a keen eye for detail and accuracy.
• Proficiency in interpreting scientific and clinical data.
• Experience working with cross-functional teams and managing multiple projects simultaneously.
• Familiarity with regulatory submission publishing software and document management systems.
• Strong organizational and project management skills.
• Ability to work under pressure and meet strict deadlines.

Benefits

• Highly competitive salary and performance-based bonus structure.
• Comprehensive medical, dental, and vision insurance plans.
• Generous annual leave and company holidays.
• Retirement savings plan with company matching.
• Opportunities for professional development and continuing education.
• Access to cutting-edge research and development facilities.
• A collaborative and supportive work culture.
• Relocation assistance available for qualified candidates.