- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The Role As part of our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior ... Director , USMA Solid Tumor Portfolio. This role will report to the VP/Head of US Medical Affairs and will be responsible for building and leading the USMA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...and transparent ways of working across the Alliance within US regulatory affairs and will work closely… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Qualifications7 or More Years in the pharmaceutical industry4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA Travel Ability to travel up to 30%… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all… more
- Daiichi Sankyo, Inc. (Bernards, 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 formulation of strategy for global regulatory submissions in Oncology in the US , EU, Japan, China, and other regions. This position ensures alignment of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience with ex- ... 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. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including CCDS and US /EU labeling experience ... pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experienceExperience with ex- US… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …understand the importance of, key internal constituents - Market Insights, Analytics, Medical Affairs , Sales Training, etc. Present to various internal ... 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. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub...as the company liaison with the Health Authority (eg, US FDA and EU EMA) for assigned projects with… more
- Merck & Co. (Rahway, NJ)
- …commercial teams and cross divisional teams including R&D and manufacturing, medical affairs , Outcomes Research and AccessExecutional Excellence: Ability to ... teams and cross divisional teams including R&D and manufacturing, medical affairs , Outcomes Research and AccessExecutional Excellence:...in certain states and cities within the United States . Final determinations with respect to… more
- Merck & Co. (Rahway, NJ)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... Job DescriptionThe Executive Director , Device Quality & Regulatory will play a...overseeing the quality assurance and regulatory CMC for complex medical devices, including auto-injectors and other innovative drug delivery… more
- Merck & Co. (Rahway, NJ)
- …Disease strategyLung Liaison on the organization's Pan-Tumor Early-Stage SquadCollaboration with Medical Affairs on strategic choices for advisory boards, ... a complex set of stakeholders, including research and development, medical affairs , regulatory affairs , market...in certain states and cities within the United States . Final determinations with respect to… more
- Merck & Co. (Rahway, NJ)
- …commercial teams and cross divisional teams including R&D and manufacturing, medical affairs , Outcomes Research and AccessExecutional Excellence: Ability to ... a key growth driver for our company.These three Associate Director roles, Healthcare Provider (HCP) Strategy, Scientific Strategy, and...in certain states and cities within the United States . Final determinations with respect to… more
- Merck & Co. (Rahway, NJ)
- …following: Work effectively with cross-functional partners including research and development, medical affairs , regulatory affairs , manufacturing, Business ... Job DescriptionWe are currently recruiting for a Global Marketing Director for metastatic lung cancers. Our Marketing team is...in certain states and cities within the United States . Final determinations with respect to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Merck & Co. (Rahway, NJ)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... to help create a healthier future for all of us .- Our ability to excel depends on the integrity,...and dedicated colleagues while developing and expanding your career.--The Director (Principal Scientist) has primary responsibility for the planning… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position As Senior Medical Director for the novel modalities team, you will be part of building, ... the VP Medical /Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams.… more
- Genmab (Plainsboro, NJ)
- …Security Operations TeamBusiness leaders (eg, VP Medical Affairs , VP Regulatory Affairs , GM Genmab US , IT Lead in Japan)Peers within IT&D, such as ... will include stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US...and IT&D leaders, with a main focus in the United States .IT&D Partner: Acts as security partner… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …role will closely partner with Field Sales, Market Access, Commercial Excellence, Medical Affairs , Strategic Partnerships and Engagement, Customer Experience and ... strongly preferred Expert understanding of the pharmaceutical industry including marketing, medical , access, public affairs , compliance, legal and regulatory as… more
