As a PPD FSP Clinical Research medical Advisor you may support a variety of designated therapeutic areas including Cardio-Renal-Metabolic/Immunology/Neuroscience.
Participation in Trade Association calls in listening & learning, observer mode by leveraging the discussion and lessons learnt onto CMC Regulatory Intelligence databases.
Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team
The incumbent will be responsible for performing analytical method development and validations for USP/NF monographs and maintaining safety and GLP environment in the lab.
Having Injectable Experience of Shop floor supervising activities like Filling, Sealing, Stoppering, Garment Washing Machine, Vial Washing, Autoclave, Ophthalmic, Suspensions, filtration, Lyophilizes. Operations and Training and QMS.
genetically modified pancreatic islet cells transplanted into a man with type 1 diabetes, without the need for immune-suppressing drugs. For twelve weeks, the cells survived, produced insulin, and functioned naturally.