- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- **Job Summary** **** The Associate Director , MSAT - Downstream provides specialized technical leadership and oversight for all downstream manufacturing ... This role is responsible for ensuring the robustness, scalability, and compliance of downstream operations through effective technology transfer, validation support,… more
- Merck (Trenton, NJ)
- **Job Description** **Role Summary** + The Regional Medical Scientific Director (RMSD) is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease expert ... management, communication, and networking skills + A thorough comprehension of FDA , OIG, HIPAA, and other ethical guidelines, laws, and regulations relevant… more
- Merck (Rahway, NJ)
- …and issues related to submission content management, quality and standards compliance + Engage across functional areas to identify opportunities for improvement; ... years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR a… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- … Oversight: Offer strategic regulatory advice to cross-functional teams and ensure compliance with FDA , EMA, and Health Canada regulations. Assess regulatory ... Biosimilars, and Small Molecules.Ensure alignment with regulatory trends, innovation, and compliance while balancing business benefits and risks. + Lead and Manage… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …resource plans required to complete own deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets. + Ensures own work ... + BA/BS with 10+ years' relevant experience. + Significant regulatory, quality, compliance or related experience in the biopharma industry. + Proven track record… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …Leads all aspects of a team in SM business unit, guiding compliance , product development, and clinical validation. **Key Responsibilities:** + Strategic Medical ... educational, promotional, and advertising materials to ensure clinical accuracy and compliance with regulatory standards. + Work collaboratively with R&D, Marketing,… 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 ... and Standard Operating Procedures to optimize MA functioning in terms of leadership, compliance and productivity. The Director , Medical Affairs, will assist the… more
- RWJBarnabas Health (Long Branch, NJ)
- …governing biomedical research; ensuring that all IRB activities and documents are in compliance with OHRP and FDA regulations + Attends local and national ... Assistant Director , Institutional Review Board - Long Branch, NJReq...medical errors, and patient safety concerns. Qualifications: Required: + Associate 's Degree + 3 years of experience related to… more
- J&J Family of Companies (Raritan, NJ)
- …across the site. The **Site Based Compliance Manager,** reports to the Associate Director , Regulatory Compliance for Large Molecule and Advanced ... for humanity. Learn more at https://www.jnj.com **Job Function:** Legal & Compliance **Job Sub** **Function:** Enterprise Compliance **Job Category:**… more
- Merck (Rahway, NJ)
- **Job Description** ** Associate Director HVAC** **:** The HVAC Associate Director is responsible for leading and developing a team that supports HVAC ... role ensures HVAC systems comply with regulatory standards (eg, FDA , cGMP), maintain optimal environmental conditions for product quality,...combined with leadership skills to manage teams effectively. The Associate Director of HVAC is a key… more