- Novo Nordisk Inc. (New York, NY)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal ... Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive...support of the development objectives for DCR-PHXC and assist Regulatory Strategy staff in the compilation of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …partners, including but not limited to: Global Clinical Operations, Global Regulatory Affairs , Biostatistics and Data Management, Epidemiology, Patient Advocacy, ... to make recommendations for process improvements - Compliance- Partner with Global Regulatory Affairs to ensure current regulatory requirements are… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Research programs for development of early clinical studies. Provides senior level clinical representation at meetings with health authorities; Leads the ... creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions...strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO, as needed; Accountable for clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …programs.- Partner and collaborate with Clinical Operations, Biostatistics and Data Management, Regulatory Affairs and other RD functions to ensure effective ... position may be at the executive director level or senior director level, depending on the scope and size...Management)- Partner and collaborate with global marketing, global medical affairs , global payers and access and commercial business units… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery ... for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …procedures, and regulations, for their assigned TA. The AD partners with senior colleagues in developing and implementing improvements in medical review processes ... and is also an integral member of the Medical Affairs Team. This position plays a key role in...review and other MIE and MA functionsPartner with MA staff in other functions to drive consistent interpretation of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cross-functional project teams, including Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs personnel to manage preparation of the ... and global project teams. This role will be a senior member of the Regulatory , Quality and...Process Improvement, and Resource Planning: Coaches, mentors, and trains staff in the finer points of medical writing Assesses… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs , is responsible for the ... marketed products in US and Canada. In addition, the Senior Director, Commercial Regulatory Affairs ,... regulatory knowledge and provides guidance to commercial regulatory staff and company management; identifies the… more
- City of New York (New York, NY)
- … and legislative developments affecting the Department and, in conjunction with Executive Staff , prepare a legislative and regulatory agenda for the Department, ... responsible for maintaining a safe and secure environment for staff , visitors, volunteers, and people in our custody. Importantly,...and City authorities. - Work directly with the most senior personnel in the Department to prepare contracts and… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** The Staff Regulatory Affairs Specialist will work in BD Medical - Pharmaceutical Systems Business Unit taking on a lead role at ... claims and communication, Advertising/promotional materials, and labeling + Conduct trainings on regulatory issues for staff and for business customers (eg,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global ... Regulatory Affairs organization and acts as a...the GRA Labeling function globally and interacts with cross-functional senior leadership to resolve complex issues, including leading and… more
- City of New York (New York, NY)
- …about a million passengers a day, making TLC the most active for-hire transportation regulatory agency in the world with oversight of a key component of the city's ... a model for other cities. TLC is seeking a Director of Intergovernmental Affairs with intergov and/or legislative experience to be the agency's principal liaison… more
- New Jersey Institute of Technology (Newark, NJ)
- …Type: Staff Position Summary: The Chief of State Government Affairs (CSGA) develops and implements strategies for representing the university's interests at ... Title: Chief of State Government Affairs Department: Office of the President Reports To:...and mutually beneficial relationships with government officials, legislators and staff , policy leaders, advocacy organizations, and others. The CSGA… more
- TD Bank (New York, NY)
- …role. **Line of Business:** Risk Management **Job Description:** The Regulatory Relationship Manager II provides strategic oversight, assistance, and relationship ... management with multiple US regulatory agencies (ie Federal Reserve Banks, Comptroller of the...Protection Bureau, Federal Deposit Insurance Corporation, Department of Veterans Affairs , Department of Housing and Urban Development, Small Business… more
- Bristol Myers Squibb (Madison, NJ)
- …Ph.D., MD, PharmD, MS, or BS **Experience Requirements** Significant experience in regulatory affairs (eg > 4-7 years) **Key Competency Requirements** Required: ... issues, and risks in written and verbal format to regulatory senior leadership team and other governing...cares about your well-being and the well-being of our staff , customers, patients, and communities. As a result, the… more
- City of New York (New York, NY)
- …efficiencies in response to agency mandates, increased need for DVS services, regulatory compliance and regular data requests from senior leadership, City ... NM II, to function as a Program, Policy, and Domestic Violence Regulatory Compliance Specialist who will: Under administrative direction of the Assistant Deputy… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director, Pipeline Head for Neuroscience, Global Health Economics, Value, and Outcomes Date: May 14, 2024 Location: Parsippany, United States, New Jersey, ... customers, and their decision making systems; in partnership with Medical Affairs , develop the HEOR/access evidence plans and payer engagement strategies for… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …strong relationships with a wide range of stakeholders at all levels (eg, Senior Executive Team, board members, KOLs, regulatory bodies, investors, peers on ... The company handles research, clinical development, sales, marketing, medical affairs , and business development functions. MTPA is dedicated to...and creating hope for all facing illness. As a senior member of Clinical Operations, the Senior … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your ... the care of patients with life-threatening diseases. We are seeking a dynamic Senior Director of Scientific Publications with a focus on Oncology to lead our… more
