- Novo Nordisk Inc. (Plainsboro, NJ)
- …and manuscripts, when requested Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 30% overnight ... About the Department The Clinical, Medical and Regulatory (CMR) department at...certain instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with cross-functional teams, including members of the CDSE team, clinical development, medical affairs , regulatory , and commercial, to facilitate the ... About the Department The Clinical, Medical and Regulatory (CMR) department at...and more broadly within Clinical, Medical and Regulatory , Market Access and Public Affairs . Externally,… more
- Merck & Co. (Rahway, NJ)
- …collaboration with multiple internal stakeholders across HH, our Research & Development Division, Medical Affairs , Regulatory , Legal etc. as well as external ... use of the digital pathology tools in collaboration with Medical Affairs and our Research & Development...sciences and/or healthcare space Understanding and experience with global regulatory requirements for Medical Device and/or AI… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Early Product Asset Owner. Collaborates with cross-functional teams, including marketing, medical , R&D, regulatory affairs , finance, NNI Global, Market ... clinical trials, and market research. Collaborate with marketing, market access, and medical affairs teams to develop early brand positioning, priority customer… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …conduct of clinical trials is required Demonstrates technical expertise within Clinical Development, Medical Affairs , and Regulatory Affairs (CMR), ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and ... an effective implementation and oversight model to maintain best-in-industry regulatory compliance.The Vice President Regulatory Affairs ,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, efficient, ... on the development and registration activities for the respective medical products.-Providing regulatory support for due diligence...devices, the majority of which must be in diagnostic regulatory affairs .-Preferred: MS with minimum of 8… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Strategy, Pipeline, BD&L. Collaborates with cross-functional teams, including portfolio, marketing, medical , R&D, regulatory affairs , analytics, and other ... states. Work collaboratively with cross-functional teams including research and development, regulatory affairs , and commercial teams, to align product… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg integrated… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Eisai, Inc (Nutley, NJ)
- …of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial outputs for assigned therapeutic ... and make a difference. If this is your profile, we want to hear from you.The Medical Director, US Medical Affairs provides medical leadership for … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe US CA Veterinary Insights and Medical Affairs Director sets the strategic vision for the development, refinement, and implementation of ... ensure compliance and alignment with standards of care.- The Veterinary Insights and Medical Affairs Director leads a best-in-class team by establishing a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to goals set by related internal groups (eg patient advocacy, ID Office, field medical , regulatory affairs , etc.)-Establish and oversee indication or study ... to process space. Present proposals for approval to appropriate leadership.Collaborate with medical affairs or the DAST to create, maintain and update the TA's… more
- Eisai, Inc (Nutley, NJ)
- …late-stage pipeline and marketed products, interfaces with cross-functional teams including US medical affairs , marketing, market access global value and access ... emanating from these effortsDrive ongoing collaboration with cross-functional teams (eg, US medical affairs , HEOR, marketing, market access, global value and… more
- Eisai, Inc (Nutley, NJ)
- …late-stage pipeline and marketed products, interfaces with cross-functional teams including US medical affairs , marketing, market access global value and access ... emanating from these effortsActively collaborate with cross-functional teams (eg, US medical affairs , marketing, market access global value and access… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... around rare diseases and immune disorders.Summary With the Head of Government Affairs & Public Policy, this position will help lead Daiichi Sankyo's engagement… more
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