- 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
- Merck & Co. (North Wales, PA)
- …Document for projects of increasing complexity.Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change ... Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist / Director is responsible for developing and… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(GRL Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, ... with other therapeutic area leaders and joint Alliance partners.Responsibilities:Lead a multidisciplinary Global Regulatory Team (GRT) to develop global … 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
- 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 PharmacometricsThe Quantitative Pharmacology and Pharmacometrics (QP2) department… more
- Merck & Co. (North Wales, PA)
- …corporate standards and policies and business objectives.Actively participate in labeling and global regulatory team meetings to ensure support for anticipated ... Job DescriptionReports to the Director /Senior Director in the Office of...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… 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
- Merck & Co. (North Wales, PA)
- …Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy for their assigned projects in the ... oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those...or Ph.D. or other related doctoral degree in biological science , chemistry or related discipline. Other degrees such as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implement the preparation of all regulatory submissions and provide regulatory support across all global projects, securing the cooperation of others ... 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
- 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)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you.The Director , Global IT Governance, Risk & Controls Management Lead is responsible for ... the strategic and execution perspectives for Eisai. Reporting directly to the Executive Director , IT Security, Compliance, & Architecture, s/he is the Global IT… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (North Wales, PA)
- …communication skills; experience collaborating with statisticians, clinicians, data managers, and regulatory and working in a global environment and ... Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences ), a distinguished department within our company's renowned Research and Development division,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …may serve as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Medical Director serves as the subject matter expert for our… 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
