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Lead Scientist, Document Compliance
Location :
Remote
Job Type :
Internal Direct
Hours :
Full Time
Required Years of Experience :
7+
Required Education :
Masters, PhD, or PharmD
Travel :
No
Relocation :
No
Job Industry :
Pharmaceutical
Job Category :
Pharmaceutical Operational Support
Job Description :
- Generate internal and external documents such as assay protocols, summary reports, and SOPs
- Work with clients during initial and subsequent transfer of assays and analytical methods to support GMP manufacturing campaigns
- Provide instrumentation care, maintenance, troubleshooting, and data interpretation
- Accurately capture data in a timely manner, including maintenance of detailed records in compliance with applicable cGMP, safety, and environmental requirements
- Writing protocols, reports, and performing and coordinating testing to support analytical development, manufacturing process development, process validations, and manufacturing investigations across functional groups
- Effectively communicate scientific data and results across technical teams, project teams, and to the health authority as needed
- Contributing to the identification of novel targets by partnering with discovery research teams to bring a clinical perspective into the earliest stages of target identification and validation, and executing clinical studies to evaluate the relevance
- Key member of an early development team, providing leadership in designing and executing early clinical development strategy
- Development and execution of studies to validate clinical platforms utilizing established and novel biomarkers
- Provide clear, timely communication and interpretation of study results to therapeutic area governance, functional area experts and development review committees
Required Qualifications :
- MD or MD/PhD; or
- PhD/PharmD; at least 7 years of experience to include biologic, pharmaceutical, or medical device industry
- Proven track record in clinical medicine or clinical research, and background in biomedical research.
- Strong interpersonal, writing and presentation skills, as well as the ability to function in a team environment are essential.
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