to facilitate decision-making process. Assess and interpret the process impact of new PV tools and processes. Requirements: Life... Sciences, Information, or similar background (Bachelors, Masters). 5+ years Drug Safety/Pharmacovigilance experience...
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC submissi...
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC submissio...
Responsibilities: Develop and execute commissioning, qualification, and validation protocols for equipment, utilities, and facilities in line with industry regulations and client specifications. Assist in the creation and revision of St...
Responsibilities: We are seeking experienced CQV (Commissioning, Qualification, and Validation) Engineers with a strong pharmaceutical background to join our team in Pennington, NJ. The ideal candidate must be ready to work fully onsite...
Responsibilities: We are seeking experienced CQV (Commissioning, Qualification, and Validation) Engineers with a strong pharmaceutical background to join our team in Pennington, NJ. The ideal candidate must be ready to work fully onsite...