- Merck & Co. (Rahway, NJ)
- …Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Provides ... Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance our… more
- Merck & Co. (Rahway, NJ)
- …Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. Key ... are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …state government affairs strategy and engagement. Contributes to internal and external advocacy and educational materials and provides support to leadership in ... around rare diseases and immune disorders.Summary With the Head of Government Affairs & Public Policy, this position will help lead Daiichi Sankyo's engagement… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …living. Are you ready to make a difference? The Position The Medical Affairs Postdoctoral Fellowship is a one-year, experiential program based in Plainsboro, New ... within the pharmaceutical industry. The fellow will provide assistance to the Medical Affairs department at Novo Nordisk Inc. The fellow will gain the skills needed… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director, Scientific Affairs (EDSA) maximizes meaningful bi-directional scientific exchange with the worldwide clinical and academic ... studies program in partnership with late-stage development teams in Medical Affairs while also supporting early-stage development teams. The role also partners… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leadership team for DS US Oncology Business Division, the Vice President, Medical Affairs will actively contribute to the creation, championing, and execution of the ... long-term vision for the Company. The position will also lead the Medical Affairs organization which is responsible for providing impactful medical support to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SummaryThe Director, Global Oncology Medical Affairs , Evidence Generation role is responsible for co-leading a cross-functional ... Outcomes Research partner.- As a member of Global Medical Affairs Team (GMAT, or Joint Medical Affairs ...plans for delayed activities. Ensure that appropriate internal and external communication is current and clear.- Drive the development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …living. Are you ready to make a difference? The PositionThe Regulatory Affairs Therapeutic Area Postdoctoral Fellowship is a one-year, experiential program based in ... for Doctors of Pharmacy within the pharmaceutical industry with a focus on Regulatory Affairs for prescription drugs and devices at Novo Nordisk Inc. The fellow will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …counsel for particular stakeholder group(s) within the Market Access & Public Affairs department and interacts with headquarters and other affiliates as required. ... interact with government agencies, law firms, trade organizations and other external agencies. Reports to Deputy General Counsel. Essential Functions Provides advice… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meetings. This position mentors/instructs and provides guidance to internal and external direct/indirect reports. This position also interacts with other therapeutic ... the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi Sankyo governance processes,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and maintains constructive ... rules). Works with manager to compose letters incorporating NN position on external regulatory initiatives Works with Group Manager to maintain surveillance of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …variety of processes and projects for all of Legal & Corporate Affairs (LCA) including but not limited to: Vendor/Budget Management, Records Management, Litigation, ... orders (increasing/closing), processing of invoices, processing check requests for Legal Affairs , annual law firm retention letters, tracking rate cards, tracking… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ... labeling regulations for products and filings. Manages compliance with internal and external guidelines, reviewing US and EU package inserts with regard to both… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Affairs . Other internal relationships include managed care, trade, government affairs and global marketing. External relationships include relations with key ... will have regular contact with cross-functional areas, including Marketing, Medical Affairs , Medical Operations and Legal. This structured approach will allow for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management organization and will report directly to the Head of Global External Stakeholder Engagement. This position will be responsible for supporting the global ... and transparency reporting laws/regulations for additional DSI Compliance or Legal Affairs review.- CBER MeetingsWhen live CBER Committee or CBER Steering Committee… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Global organization to drive scientific exchange and communication with external Key Opinion Leaders (KOLs), Healthcare Professionals (HCPs), and other ... Area in certain instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in developing agenda for and executing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oncology Business Unit/US Oncology Business Division (including, for example, Medical Affairs , Sales, Marketing, Market Access, etc.) including, but not limited to, ... counsel and direction to other members of the Legal Affairs Department as well as serving as a mentor...projects-internal to the Company as well as project involving external business partners and/or other entities. The result of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and drives cross-functional collaboration within the business and with external partners, enabling strong, collaborative working relationships. Relationships Reports ... Lead. Responsible for providing interface with key internal and external stakeholders. Collaborates with cross-functional teams,global 5D, Marketing, Strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as ... for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other regions, including Japan, while developing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as is required. Provides appropriate counsel and direction to other members of the Legal Affairs Department as well as serving as a mentor in order to foster their ... AMP, ASP, and federal and state price reporting. Supervise external outside counsel.- Serve as a member of Labeling...economics initiatives) on an as-needed basis.- Liaise with Government Affairs colleagues on proposed and enacted laws relating to… more
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