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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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