Manager of Scientific Medical Writing

at  AL Solutions

My leading Biotech client is seeking a highly skilled Manager of Scientific Medical Writing to join their team in Mainz, Germany. In this critical position, you will provide hands-on expertise to deliver high-quality clinical documents that effectively communicate science and meet regulatory requirements.

REQUIREMENTS:

• PhD in life sciences or related field with 5+ years of medical writing experience in the biopharma industry
• Expert knowledge of ICH guidelines and experience with global regulatory submissions
• Leadership skills with a hands-on approach to managing multiple projects and priorities
• Excellent time management, communication, collaboration, and problem-solving skills
• Proficiency in MS Office; experience with document management systems
• Fluent in English and German (written and verbal)

• Work in a team of medical writers writing clinical study protocols, clinical study reports, investigator brochures, and more
• Provide hands-on medical/scientific writing and authoring for regulatory submissions and publications
• Coach and mentor medical writing staff and ensure quality standards are consistently met
• Partner cross-functionally with clinical operations, regulatory affairs, statistics, and medical teams
• Develop SOPs, and style guides, and optimize processes for medical writing activities
• Establish timelines, provide status updates, and ensure on-time delivery of writing projects