Medical Writer - Clinical Study Reports

Placements24; Cape Town; Presencial; ZAR 900.000 - 1.200.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary

Comprehensive benefits package

Professional development and training

Collaborative work environment

Exposure to cutting-edge R&D

Descripción de la vacante

Placements24 is seeking a highly skilled Medical Writer to join the regulatory affairs team in Kimberley. You will author and finalize CSRs, protocols, IBs, and study plans for clinical development, ensuring accuracy and regulatory compliance.

You will collaborate with clinical operations, biostatistics, and regulatory groups to deliver high-quality documentation under tight timelines in a fast-paced pharma environment.

Formación

• Advanced degree in life sciences (Master’s or PhD).
• Experience as Medical Writer in pharma/biotech for 4+ years.
• Strong experience in writing clinical/regulatory documents, esp. CSRs.
• Solid knowledge of ICH guidelines and regulatory processes.
• Excellent written and verbal communication, detail-oriented.

Responsabilidades

• Author, edit, and finalize CSRs for Phase I–IV trials.
• Develop and maintain protocols, IBs, and study plans.
• Prepare responses to regulatory questions and contribute to submissions.
• Ensure outputs are scientifically accurate and regulatorily compliant.
• Collaborate with cross-functional teams to gather information and meet deadlines.
• Review others' work for accuracy and consistency.

Conocimientos

Medical writing

Regulatory writing

CSR writing

Educación

MSc in life sciences

PhD in life sciences

Descripción del empleo

About the Role

Our client is seeking a highly skilled Medical Writer to join their regulatory affairs department in Kimberley . This role is dedicated to authoring clear, concise, and accurate clinical study reports (CSRs), protocols, and other regulatory documents essential for drug development and submission. You will collaborate closely with clinical operations, biostatistics, and regulatory teams to ensure all documentation meets the highest scientific and regulatory standards. The ideal candidate possesses exceptional writing skills, a strong understanding of clinical research, and meticulous attention to detail in a fast-paced pharmaceutical environment.

Key Responsibilities

• Author, edit, and finalize clinical study reports (CSRs) for Phase I-IV clinical trials.
• Develop and maintain clinical trial protocols, Investigator's Brochures (IBs), and study plans.
• Prepare responses to regulatory agency questions and contribute to submission dossiers.
• Ensure all medical writing outputs are scientifically accurate, compliant with regulatory guidelines, and consistent in style and tone.
• Collaborate with cross-functional teams to gather information and ensure timely completion of documents.
• Review and critique the work of other medical writers and team members.

Requirements

• Advanced degree (Master's or PhD) in a life science, medical, or related field.
• Minimum of 4 years of experience as a Medical Writer in the pharmaceutical or biotech industry.
• Demonstrated expertise in writing various clinical and regulatory documents, especially CSRs.
• Thorough understanding of ICH guidelines, regulatory requirements, and clinical trial processes.
• Exceptional written and verbal communication skills, with a keen eye for detail and scientific accuracy.
• Ability to manage multiple projects simultaneously and meet strict deadlines in Kimberley.

Benefits

• Competitive salary and comprehensive benefits package.
• Opportunities to contribute to diverse therapeutic areas and drug development programs.
• Professional development and training in medical communication and regulatory science.
• Collaborative and supportive work environment.
• Exposure to cutting-edge pharmaceutical research and development.