- Novo Nordisk Inc. (Plainsboro, NJ)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead . Essential Functions Serve as a member of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution.Participate in global ... assigned to alliance assets for operational matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible ... Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report...programs, target product profile, and competitive labeling precedent.Act as Global Labeling Lead , supporting development, approval and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory ... Lead actively engages with leadership across the Global Regulatory Affairs and Clinical Safety organization...that they own. Lead large-scale change initiatives across Global Regulatory Affairs and Clinical Safety and… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director, Global Clinical Drug Supply to be part of Global Clinical Drug ... planning of operational excellence, strategic planning, and innovation implementation for the Global Clinical Drug Supply team. The individual will have the ability… 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 ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… 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 ... into a global strategy.Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...or More Years of proven experience in a regional regulatory lead role7 or More Years of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as Diabetes and Bio Pharm Field Sales, Managed Care, Trade and Government, Medical, Regulatory , Legal personnel and may advise Global Teams with regard to ... and HCP program operations and technology systems. This position will also lead the development of operational business plans to meet evolving regulations and… more
- Merck & Co. (Rahway, NJ)
- …a subject matter expert, providing advice and guidance on labeling to teams.As the regulatory labeling liaison on global Regulatory Affairs subteams, your ... in people and animals. In the capacity of a Global Labeling Lead , you will be instrumental...Labeling for assigned products, ensuring compliance with internal and regulatory standards.You will assist in the development and maintenance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The HCP - Strategy Lead (MASH) lead will be a pivotal driver in shaping an insights-driven HCP ... area vision and message. Relationships Reports to the Integrated TA Strategy Lead . Responsible for providing interface with key internal and external stakeholders.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Early Development, Development, innovation hubs across NN, other affiliates, and global . We're looking for individuals who are enterprise thinkers, inclusive ... our future. The Position The Rare Bleeding Therapeutic Area Lead is instrumental in shaping and executing NNI's strategic...for the TA. This role also contributes to the global TA strategy by working closely with global… more
- Merck & Co. (Rahway, NJ)
- …Primary responsibilities include, but are not limited to: Serve as the Regulatory Project Lead for assigned device and combination products, guiding ... NDA/MAA, agency background packages, post-approval submissions/variations, 510(K)s, CE markings. - Lead the development, communication, and review of Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the ... 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 ... 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Early Development, Development, innovation hubs across NN, other affiliates, and global . We're looking for individuals who are enterprise thinkers, inclusive ... on shaping our future. The Position The Ecosystem & Enterprise Influence Lead is responsible for driving strategic initiatives to address the complex challenges… more
- Merck & Co. (Rahway, NJ)
- …communications for the company's worldwide manufacturing organization, which spans a global network of sites for pharmaceuticals, vaccines, biologics and animal ... stakeholder engagement communications activities in close partnership with teams across the Global Communications function. This role is based in Rahway, NJ. Scope… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... research areas centered around rare diseases and immune disorders. Summary The Global Service Manager (GSM) focusing on Incident, Problem, and Change is responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and/or analytical development activities and oncology project development.Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience (UDX) strategies. In this position, the Non-Regulated Implementation Services Lead will collaborate closely with cross-functional Global DX teams, ... 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
