- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …documents, including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. ... on the large global clinical trials and regulatory filing activities. The Senior Director , GCD...trial implementation and management. + Complete understanding of the global regulatory requirements. + Working knowledge of… more
- Sanofi Group (Morristown, NJ)
- …, etc.) + Partners effectively with relevant departments (eg Commercial, Clinical Development, Regulatory Affairs , Medical Affairs , HEOR, etc.) to influence ... **Job Title:** Director , Global Market Access and Pricing...access and pricing strategy in partnership with the therapeutic global cross-functional colleagues (eg Commercial, Clinical, medical, regulatory… more
- Merck (Rahway, NJ)
- …years of experience in global patient advocacy and engagement activities + US/ global experience in regulatory affairs , medical and scientific affairs ... **Job Description** The Executive Director and Global Lead, Patient Advocacy...in the Value & Implementation (V&I) organization, which includes Global Medical and Scientific Affairs as well… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …for new products. Preferred **Knowledge and skills** + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements ... Drive Labeling Strategy, in-line with overall global regulatory strategy, by providing labeling expertise for Company Core Data Sheet (CCDS), USPI and local… more
- Pentax Medical (Montvale, NJ)
- …manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global medical community. Position Opening: Director , Global ... Time Off and Holiday policy. Want More INFO? The Director , Global Compliance will be a...the PENTAX Medical organization (legal, HR, operations, internal audit, QA/ RA , sales and marketing) with primary focus on the… more
- J&J Family of Companies (Titusville, NJ)
- …via matrix interactions also includes individuals from project management, TA strategy, global regulatory affairs , finance, legal, quality assurance, quality ... for the preparation and approval of essential documents for global regulatory filings. The CL will manage...emerging from the Team and its affiliates + Assists Regulatory Affairs in the development of drug/device… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …study report (FSR), including authoring statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more
- Bristol Myers Squibb (Madison, NJ)
- …Science and Technology, Business Process Management, Internal and External Manufacturing, Regulatory Affairs , Brand Teams, Legal, Patient Safety, Medical ... executed in strict adherence to applicable regulations and BMS standards. The Executive Director leads a team dedicated to maintaining global compliance across… more
- Merck (Rahway, NJ)
- …best practices in those areas + US/ Global experience in clinical research, regulatory affairs , scientific and medical affairs , or pharmaceutical policy + ... , Oncology, Patient Advocacy, Patient Insights, Pharmaceutical Industry, Pharmaceutical Medical Affairs , Relationship Management, US Regulatory Affairs … more
- J&J Family of Companies (Titusville, NJ)
- …for product hierarchies, nomenclature, and lifecycle transitions. + Partner with Regulatory Affairs , Clinical Operations, Supply Chain, and Commercial to ... contextualize product information across silos, enabling advanced analytics, AI/ML, regulatory compliance, and global interoperability. **Key Responsibilities**… more