- AbbVie (Cambridge, MA)
- …conferences and publications of translational findings in peer reviewed journals, new drug applications and regulatory filings. Key Responsibilities: . Lead a ... a highly motivated and experienced AI/ML leader to transform our drug discovery and development through cutting-edge method and technology innovation. AbbVie's… more
- Bristol Myers Squibb (Princeton, NJ)
- …oncology drug development * Managing all clinical components of regulatory documents, including filings for initial registration and LCM indications * Serving ... 3 clinical trials within related areas of focus * Significant successful global drug filing expertise and regulatory interaction experience (ie NDA, ODAC, oral… more
- Merck (West Point, PA)
- …with internal and external stakeholders such as drug substance, drug product, device, analytical, regulatory , project leaders, manufacturing sites, and ... responsible for delivering robust packaging systems for cell banks, drug substance, drug product, and finished goods....team members + Remain informed of current quality and regulatory requirements and industry trends as described in worldwide… more
- UPMC (Pittsburgh, PA)
- …treatment in accordance with the Practicing State's Pharmacy Practice Act, Federal Drug Laws, and other regulatory organizations. + Prepare and dispense ... minimizing non-formulary procurements, utilizing therapeutic interchange protocols, and promoting rational drug therapy selection. + Adhere to all regulatory … more
- Stony Brook University (Stony Brook, NY)
- …a minimum of three (3) professional references. + Successfully complete a 4 panel drug screen * + Meet Regulatory Requirements for pre employment screenings. + ... In addition, the **Research Nurse** is responsible for reporting all adverse drug reactions to the FDA, NCI, Oncology cooperative groups, IRB and sponsoring… more
- Lilly (Indianapolis, IN)
- …of CMC drug development science(s) + Knowledge of CMC global regulatory requirements and guidelines related to parenteral drug product manufacturing and ... that make life better for people around the world. Lilly is looking for regulatory Chemistry, Manufacturing and Control (CMC) scientists to join us in developing and… more
- Lilly (Indianapolis, IN)
- …CMC drug development science(s). + Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product ... for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and... initiatives desirable. + Relevant experience in synthetic molecule drug substance and/or drug product development, commercialization,… more
- Bristol Myers Squibb (Devens, MA)
- …risks, and presenting timelines and strategies for endorsement. + Represent the Drug Product manufacturing process in regulatory interactions such as inspections ... is highly cross-functional and challenging, involving leadership across all sites of Drug Product manufacture for the designated product. In this role the Technical… more
- Ascendis Pharma (Princeton, NJ)
- …FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. The Senior Manager Regulatory Affairs, ... in Regulatory Affairs promotion and advertising working with prescription drug , biologic, and/or combination products; experience managing major regulatory … more
- Stony Brook University (Stony Brook, NY)
- …a minimum of three (3) professional references. + Successfully complete a 4 panel drug screen * + Meet Regulatory Requirements for pre employment screenings. + ... service lines. **Preferred :** + Certification in specialty. . + Regulatory /certification management experience. **Please Note:** Verification of degree (eg, diploma… more