Director Of Medical Writing
AL Solutions
Mainz, RP, DE
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We are currently seeking a highly experienced and motivated individual to join our Global Biotech as the Director of Medical Writing.
As the Director, you will be responsible for leading a team of medical writers and overseeing the development of high-quality scientific and regulatory documents.
Key responsibilities include :
- Managing and mentoring a team of medical writers
- Providing guidance and expertise on the development of various documents including clinical study protocols, clinical study reports, investigator's brochures, and regulatory submissions
- Ensuring compliance with relevant regulations and guidelines
- Collaborating with cross-functional teams including regulatory affairs, clinical operations, and biostatistics
- Overseeing the review, organization, and interpretation of clinical trial data
- Contributing to the development of templates, processes, and standard operating procedures
The ideal candidate will have a strong background in medical writing, with a focus on regulatory documents, and proven experience in managing a team.
Requirements
Requirements :
- Advanced degree in life sciences or related field (PhD, MD, or equivalent)
- Minimum of 10 years of experience in medical writing, with a focus on regulatory documents
- Experience in managing a team of medical writers
- Strong knowledge of regulatory guidelines (ICH, FDA, EMA)
- Excellent writing and editing skills with attention to detail
- Proficiency in using relevant software and tools (MS Office, Adobe Acrobat)
- Ability to effectively communicate and collaborate with cross-functional teams
- Strong organizational and leadership skills
If you are a highly motivated and experienced medical writer looking for a challenging leadership role, we encourage you to apply.
Benefits
- competitive salary.
- Hybrid working.
- Annual salary reviews.
- Medical insurance.
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