Medical Writer & Product Safety Officer

GCP-Service International is looking for a Medical Writer & Product Safety Officer to join our international clinical research team at our headquarters in Bremen, Germany.

This is a combined role covering medical/scientific writing and product safety activities across clinical trials, clinical investigations and clinical evaluations. It is an excellent opportunity for someone who already has experience in one of these areas and is interested in developing their expertise in the other. 

Your Responsibilities 

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. 

What We’re Looking For 

  • 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. 

Don’t Tick Every Box? We Still Want to Hear From You. 

You don’t need to have experience in both Medical Writing and Product Safety to apply. 

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. 

If you are interested in joining our team, please use the link below to submit your application.

SUBMIT APPLICATION

Thank you for submitting your application. We truly appreciate your interest in joining our company.

Please note that the review process may take some time. If you are selected to move forward, we will contact you within two weeks. If you are not selected, please understand that we will not be sending additional updates.

In accordance with the application procedure (Art. 6 para. 1b GDPR), we will retain your application documents for a period of six months. After this time, your data will be securely deleted. You have the right to request access to, rectification, or deletion of your personal data, to restrict or object to its processing, and to request data portability.

If you have any questions regarding data protection, please contact our Data Protection Officer at dataprotection@gcp-service.com.

We wish you all the best in your job search.

Best regards,

HR team @ GCP-Service International