- BeOne Medicines (Pennington, NJ)
- …and vendor qualification. + Development of all necessary SOPs, ensuring regulatory compliance in conjunction with being appropriate both clinical and commercial ... or adverse events requiring documented review and action. + Participation in regulatory and customer inspections/audits. + Subject matter expert in GMPs: 21 CFR… more
- Bristol Myers Squibb (Summit, NJ)
- …strategies, process risk assessments, etc), inspection readiness, and technical regulatory submissions. The Sr. Principal Engineer will support commercial product ... Lead production related investigations, ensuring compliance with internal standards and regulatory requirements. + Own Stage III validation (CPV) reports including… more
- Organon & Co. (Jersey City, NJ)
- …such as mergers, acquisitions, and divestures. + Researches and interprets regulatory requirements and supports resolving tax, withholding, garnishment and wage/hour ... issues for payroll processing and responds to audit and regulatory inquiries. + Partnering with key stakeholders including HR Benefits and Compensation Center of… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …etc.) to ensure that materials and strategies are compliant with legal and regulatory requirements as well as with internal company policies. + Negotiate, draft, ... review general commercial and other contracts including HCP consultant and speaker agreements, vendor and service provider MSAs and SOWs, and liaise with internal clients and Legal colleagues to finalize same. + Counsel on FDCA and other applicable laws and… more
- Bristol Myers Squibb (Princeton, NJ)
- …Diseases. + Manage relationships with key internal stakeholders including regulatory , clinical and commercial and scientific communications and external ... collaborators to develop translational analysis plans and timelines, communicate analysis results. + Represent the Neurology Translational Medicine function at various internal meetings and provide domain knowledge and disease expertise to cross-functional… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …Analytics, Otsuka Information Technology (OIT), Sales Operations, and Medical/ Regulatory /Legal integrated business partners. **Minimum Qualification:** + Bachelor's ... degree in data sciences, computer science and 4-6 years of relevant experience **Preferred Knowledge, Skills, and Abilities:** + Demonstrated experience with scripting and implementing data analytics algorithms and models. Hands on experience using a modeling… more
- Merck (Rahway, NJ)
- …and fusion proteins. Within Mixed Modality, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. These sterile products… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …worldwide business team, regional leadership in the Medical Affairs Function and the Associate Director of Medical Affairs in Specimen Acquisition to align and ... publication and scientific exchange plans to contribute to product development, meet regulatory requirements, and support appropriate use. The Director of… more
- Humana (Trenton, NJ)
- …community and help us put health first** The Behavioral Health Medical Director is responsible for behavioral health care strategy and/or operations. The Behavioral ... Health Medical Director work assignments involve moderately complex to complex issues...be authorized. All work occurs within a context of regulatory compliance and work is assisted by diverse resources… more
- Grifols Shared Services North America, Inc (Atlantic City, NJ)
- …more than 110 countries and regions. The primary responsibility of the MSL Field Director is the management, performance, and coaching of a team of MSL direct ... (MSL primary call points include Immunology, Neurology, Hematology/Oncology). The Field Director ensures compliant execution of field medical plans, strategy, and… more