Uses external and internal insights to identify emerging trends and requirements and to inform, develop, and refine GSC and Lilly regulatory writing, content and study submission strategies
Bachelors degree in a science-related field such as Pharmacy, Chemistry, Biological Sciences, or related Life Sciences. GMP experience, with experience in pharmaceutical laboratory quality assurance, quality control, or laboratory operations in a dry product or solid oral dosage form environment. Lilly
The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards. The position requires working cross-functionally within the site and other functions to deliver on technical objectives.
Previous MSL experience or Field-Based experience building relationships with Scientific Experts and Key Opinion Leaders of neurosciences will be highly desired.
Continually seek and implement means of improving processes to reduce study build cycle time, decrease work effort and enable the normalization of various sources of data into a common data repository in a way that allows for improved integration, consumption and downstream analysis
Responsible for triage of Lilly affiliate inquiries and requests and when necessary, consults with CMC RA Scientist for guidance in effort to prepare responses to questions.
Clinical Development Organization, a division of Lilly Research Laboratories, partners with colleagues in Research, Oncology, Biomedicines, and Diabetes to effectively and efficiently design, plan, and execute clinical trials across all phases of research. Uniting authorities in clinical development and design, laboratory and data sciences
Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly.