Medical Writer & Product Safety Officer (m/f/d)

Medical Writing

• Prepare and review clinical and regulatory documents in accordance with applicable SOPs, ICH, GCP, ISO 14155 and regulatory requirements.
• Coordinate document preparation, review and approval with internal teams, Sponsors and external experts.
• Support the preparation of clinical trial, clinical investigation and clinical evaluation documentation.
• Ensure high-quality deliverables within agreed project timelines.

Product Safety

• Manage and review safety data and safety cases from clinical studies.
• Support safety reporting to Sponsors, Competent Authorities and Ethics Committees.
• Maintain safety documentation, guidelines, templates and SOPs.
• Support product vigilance databases and EMA/EudraVigilance-related processes.
• Collaborate with Project Management, Data Management, Quality Assurance and other functions.

• Bachelor’s or Master’s degree in Life Sciences, Medicine, Pharmacy or a related scientific field.
• Relevant experience in medical writing, product safety/pharmacovigilance, or clinical research.
• Knowledge of GCP and relevant clinical research regulations.
• Excellent written and spoken English.
• Strong scientific writing, analytical and organizational skills.
• Attention to detail and a quality-focused approach.
• Ability to work independently as well as collaboratively within cross-functional teams.

We offer

If you have a strong background in one of these areas and are motivated to learn and develop your expertise in the other, we would be very happy to hear from you. This role offers the opportunity to broaden your clinical research expertise, work across medicinal product and medical device projects, and develop a versatile profile within an international CRO environment.