- 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 ... advise on development strategies, and deliver on associated regulatory activities Lead the Global Regulatory Matrixed Team in defining and executing the … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Policy activities focused on the USA, alongside coordinating the global team.Responsibilities Lead and manage a global regulatory intelligence and policy ... is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through...of leading Regulatory Intelligence, this role will lead the development and implementation of a global… more
- Merck & Co. (North Wales, PA)
- …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 /...lead the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier ... Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited... of Dossier Planning will report to Head of Global Regulatory Operations and be an active… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Director , Global Oncology Marketing (Brand) is responsible for maximizing the ... value of a specific indication(s) and/or tumor type(s) under the direction of the Global Brand Lead . Responsible for actively contributing to the development of… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Director , Global Oncology Communications The role of Director , Global Communications, Oncology is a unique ... for this role will work under the guidance of the Executive Director , Global Oncology Communications in a fast-paced and ever-changing… more
- Merck & Co. (Rahway, NJ)
- …, Global Marketing for Women's Cancer for the oncology portfolio.- The Global Marketing Director will lead overall strategy development for Women's ... commercial input on such activities as: target product profile development, global regulatory filing strategy, labeling, launch readiness reviews, organized… more
- Merck & Co. (Rahway, NJ)
- … / co- lead activities as belowTarget product profile development, global regulatory filing strategy, launch readiness reviews, organized customer ... Job DescriptionWe are recruiting for a Director Global Oncology Marketing for a...communication planningThis role will also serve as the Asset Lead for MK-1308A and will have an opportunity to… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, ... device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key...RA Policy and Intelligence: Keep abreast of the changing global regulatory environment for devices and share/educate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 ... The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the manufacturing… more
- Merck & Co. (Rahway, NJ)
- …FI/CO modules.- This role reports to the Global Financial Business Management Director . Responsibilities: Leadership and Management: Lead a global team ... drive revenue and productivity, thereby advancing our company's contribution to global medical innovation.Enterprise IT (EIT) is an essential component of the… more
- Insmed Incorporated (Bridgewater, NJ)
- …of 15 years of experience as a regulatory toxicologist (study director /monitor and/or project lead ) in the pharmaceutical or biotechnology industry or ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Director , Toxicology is a key member of the nonclinical… 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 ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global harmonization of programming processes ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this… more
- Merck & Co. (Rahway, NJ)
- …drive revenue and productivity, thereby advancing our company's contribution to global medical innovation.Enterprise IT (EIT) is an essential component of the ... SAP Platform Team is responsible for our company's SAP Global Template asset, delivering enterprise-level capabilities through harmonized business...the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 ... as other research areas centered around rare diseases and immune disorders.Summary Lead the implementation of the quality strategy closely aligned with the business… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical ... development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on… more
