- Hybrid working.
- Annual salary reviews.
- Medical insurance.
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Director Of Medical Writing - Mainz, Deutschland - AL Solutions
Beschreibung
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 writersProviding guidance and expertise on the development of various documents including clinical study protocols, clinical study reports, investigator's brochures, and regulatory submissionsEnsuring compliance with relevant regulations and guidelinesCollaborating with cross-functional teams including regulatory affairs, clinical operations, and biostatisticsOverseeing the review, organization, and interpretation of clinical trial dataContributing to the development of templates, processes, and standard operating proceduresThe ideal candidate will have a strong background in medical writing, with a focus on regulatory documents, and proven experience in managing a team
RequirementsRequirements:
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 documentsExperience in managing a team of medical writersStrong knowledge of regulatory guidelines (ICH, FDA, EMA)Excellent writing and editing skills with attention to detailProficiency in using relevant software and tools (MS Office, Adobe Acrobat)Ability to effectively communicate and collaborate with cross-functional teamsStrong organizational and leadership skillsIf you are a highly motivated and experienced medical writer looking for a challenging leadership role, we encourage you to apply.
Job SummaryID:
AB619F1EAEDepartment:
Medical WritingType: full time
Nutzer der Berufsbezeichnung Director Of Medical Writing in Mainz
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Guofeng Lou
Clinical Program Manager
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Michael Kohlert
IT Director