- 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, ... in diagnostics and/or medical devices, the majority of which must be in diagnostic regulatory affairs .-Preferred: MS with minimum of 8 years of relevant … more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Senior Director , Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug ... individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg integrated ... drug/diagnostic regulatory and submission plans), including HA engagement plans and...engagement plans and mitigation strategies.Ensure high quality collaboration global regulatory leads and provides guidance to the regional strategists… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Senior Director , Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug ... individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support...of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines… 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 ... 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)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's ... regulatory group in internal and external development project meetings....guidance to peers and cross-functional team members regarding strategic regulatory issues. Develops timeline and strategic input with feedback… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 30% overnight travel required; Qualifications MD ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Area in certain instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior… more
- Merck & Co. (North Wales, PA)
- …customers around the world. Join our organization as a results-driven and visionary Director , Product Marketing Owner - HCP for Atherosclerosis. As a key leader ... our investigational novel treatment for adults with hypercholesterolemia to reduce LDL. The Director , Product Marketing Owner - HCP will play a critical role in… more
- Merck & Co. (North Wales, PA)
- …prioritiesCollaborate with key stakeholders across the enterprise including Medical Affairs , Outcomes Research, Global Marketing, Clinical, Regulatory , ... around the world. Join our organization as a results-driven and visionary Director , Product Marketing Owner - Scientific for Atherosclerosis. As a key leader… more
- Merck & Co. (North Wales, PA)
- Job DescriptionWe are currently recruiting for the position of Associate Director , US Oncology - Hematology Scientific Strategy. This talented individual will lead ... Build out a robust scientific leader (SL) engagement plan, coordinating with medical affairs , clinical research, and global marketing to provide a consistent One our… more
- Merck & Co. (North Wales, PA)
- …that interface with internal and external stakeholders, including US Medical Affairs , Regional Vaccine Medical Directors, Global Marketing, the Center for ... and advocacy perspective, ensuring alignment with marketing strategy Collaborate with Medical Affairs to develop and execute upon a scientific engagement plan that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary With the Head of Government Affairs & Public Policy, this position will help lead Daiichi Sankyo's engagement ... to the patients who need them.Responsibilities- With the Head of Government Affairs and Public Policy, develop, lead and prioritize Daiichi Sankyo's legislative and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …any time throughout the annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs . Has direct supervisory ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...support representatives in answering physicians questions Works with Executive Director to define therapeutic area disease and treatment concepts… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... contact for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other regions, including Japan, while… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations through internal technical ... significant experience in scientific/ regulatory fields required- Experience in international Regulatory Affairs - CMC preferred Daiichi Sankyo, Inc. is an… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …number of stakeholders across CDSE and more broadly within Clinical, Medical and Regulatory , Market Access and Public Affairs . Externally, this individual is ... cross-functional teams, including members of the CDSE team, clinical development, medical affairs , regulatory , and commercial, to facilitate the integration of… more
