- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to make a difference? The Position We are seeking a collaborative and science -driven global regulatory expert who wants to work with innovative ... Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro,...functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of...into a global strategy.Responsible for ensuring aligned global regulatory strategy is endorsed by GPT… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for ... to our business, which is innovative and rooted in science , we believe that being proudly unique, determined to...Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report… more
- Merck & Co. (Rahway, NJ)
- …day-to-day coaching/guidance to individual contributorsMaintaining a comprehensive understanding of global regulatory expectations for small molecules and ... Job DescriptionR5 - Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsT he (remote) position is only applicable for those that are not within… more
- Merck & Co. (Rahway, NJ)
- …Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You ... will spearhead regulatory activities for Devices and Drug-Device Combinations (DDDC), ensuring...fostering a collaborative environment Maintain in depth knowledge of global device and drug/biologic-device combination product guidelines and policy… more
- Merck & Co. (Rahway, NJ)
- Job Description Overview: The Director , Global Media Relations, is responsible for developing and executing a global media strategy that showcases our ... will build and maintain strong working relationships with pharma, science , mainstream and consumer reporters and editors within the...our Company markets under the supervision of the Executive Director , Global Media Relations. The Director… more
- Merck & Co. (Rahway, NJ)
- …Small Molecule Science and Technology (SM S&T) within our Manufacturing Division's Global Science and Engineering Commercialization.- SM S&T aims to be an ... Job DescriptionWe are seeking a visionary Executive Director to lead our End-to-End Technical Leader organization and join the leadership team of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare. The Biologics and Biopharmaceutics team is responsible for the research… more
- Merck & Co. (Rahway, NJ)
- …continued R&D and drive access to life-saving medicines for patients? If so, the Director , Biologics Patent Attorney role , at our Company could be an ideal ... areas of the business including discovery, development, manufacturing, and supply, regulatory , business development, commercial groups, and other legal functions . -… more
- Merck & Co. (Rahway, NJ)
- …chemical and biochemical processes, parenteral, oral, and specialty dosage formulations.- The director should be well engaged with regulatory and industry trends ... R&D and DSCS. --The candidate will have experience in an innovative analytical/ regulatory /GMP environment.The Director will effectively team with the SMAR&D… more
- Merck & Co. (Rahway, NJ)
- …cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. -- Specifically, the Director may ... Job DescriptionOur company is a global health care leader with a diversified portfolio...small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious… more
- Merck & Co. (Rahway, NJ)
- …modeling of tumor size and survival. A Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, ... Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Director . QP2-IO team is part of the Global...methods. Experience in IND, NDA and other submissions to global regulatory agencies. Skills in experimental design,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and ICH guidance for clinical documentsParticipate in initiatives within the Global Regulatory Writing Group to identify process improvement opportunities, ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of...around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director , Global Clinical Drug Supply to be part of Global ... to our business, which is innovative and rooted in science , we believe that being proudly unique, determined to...bringing medicines to cancer patients and other serious diseases. Director , Global Clinical Drug Supply will work… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and tracks regulatory trends, legislative changes, and guidelines issued by global regulatory agencies (FDA, EMA, MHRA, etc.) related to CSPV. Participates ... in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/ Global … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …issues with regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of... global product team meetings to provide US regulatory support and guidance as needed and manage day-to-day… more
