Medical Writer (m/f/d) for the Clinical Research Department

To strengthen our Medical Writing Team, we are looking for a

Medical Writer (m/f/d)

in Mannheim

AMSAdvanced Medical Services GmbH has been operating successfully throughout Europe as a contract research organisation (CRO) in the field of clinical research since 1997.

Renowned pharmaceutical and medical device companies are among our regular customers.

Team spirit, fairness and enjoyment of working together are the hallmarks of our company.

Our medical writers have diverse and varied tasks and create a wide range of documents in the context of clinical development.

Your responsibilities

• Independently plan, write, and coordinate regulatory study documents across all phases of clinical development (Phase I–IV, NIS, PASS) with minimal supervision
• Take full ownership of complex documents, including:
  • Study synopses and study outlines
  • Protocols, observation plans, and amendments
  • Clinical study reports and interim reports
  • Patient information sheets and informed consent forms
• Interpret and describe statistical results in a clear, regulatory-compliant manner
• Lead cross-functional teams in the creation and review of complex documents, including organizing and moderating review meetings
• Act as a key point of contact for direct communication with clients, managing expectations and timelines autonomously
• Support authors in the creation of scientific publications, including abstracts and poster presentations
• Conduct targeted literature research for the documents to be produced

Your profile

• Completed degree in natural sciences or medicine, ideally with a PhD
• At least 2 years of experience in regulatory medical writing
• Solid experience in clinical research, sound knowledge of ICH-GCP and national and relevant international regulations
• Highly independent and self-directed working style, with the ability to structure work, set priorities, and deliver results with minimal guidance
• Confident, structured and results-oriented working style
• Excellent written and spoken German and English (at least C2 level)
• Confident and efficient use of MS Office products (Word, PowerPoint, Excel)

We offer

• A professional, collegial, open-minded team with a positive and collaborative working atmosphere
• Flexible working arrangements, including partial home office/remote work and part-time options
• Flat hierarchies with short decision-making paths
• Excellent professional development opportunities in a growing company

Interested in taking the next step?

Please send your application including your CV, your earliest possible starting date and salary expectations to our Recruiting Team Recruiting-Team@ams-europe.com

Your AMS Recruiting Team

AMS Advanced Medical Services GmbH

Am Exerzierplatz 2, 68167 Mannheim, Germany