- 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 serve as an ad hoc member of Global Project Team (GPT)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible ... and strategic insights at the study team level. The Associate Director of Regulatory Writing...ICH guidance for clinical documents.Participate in initiatives within the Global Regulatory Writing Group to identify process… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Associate Director of Regulatory Writing is a key role ... and strategic insights at the study team level. The Associate Director of Regulatory Writing...ICH guidance for clinical documentsParticipate in initiatives within the Global Regulatory Writing Group to identify process… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to date- Support regulatory inspection related activities as required- Support Head, Global strategy and operations to develop and plan the Global QA ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...responsibility to collaborate with, and support the head of Global QA strategy and operations. In this position, the… 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 ... value from inception through to implementation. Demonstrates ability to handle global projects through established interactions with Japan and Europe as required.… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description: Associate Director , Site Services Procurement (NORAM) This Procurement Associate Director role will be a member of ... professionals based in various countries around the world, which is part of the Global Supplier Management Group. Scope managed by the Global Site Services… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... 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)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of ... 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)
- …an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing ... hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/… more
- Daiichi Sankyo, Inc. (Bernards, 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 ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...team and serves as ad hoc member to the Global Project Team for late stage projects. This position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be ... and more, while ensuring adherence to DS policies and procedures. The Associate Director , Regional Marketing Conventions & Field Programs is responsible… more
- Daiichi Sankyo, Inc. (Bernards, 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 ... of Daiichi Sankyo (DS) in the US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and… more
- Merck & Co. (Rahway, NJ)
- … regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research… more
- Merck & Co. (Rahway, NJ)
- …safe, sustainable and healthy future for people and communities everywhere.The role of Associate Director , ESG Strategic Reporting is a unique opportunity to ... from voluntary to regulation-driven disclosures.The role will report to the Director , ESG Strategic Reporting. Primary Responsibilities: Manage ESG reporting and… 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 ... to CDx project teams for the diagnostic, under the direction of the Global Program Teams (GPT) CDx representative for the therapeutic or under the guidance… 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)
- …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 ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight:… more
- Daiichi Sankyo, Inc. (Bernards, 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 ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… 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
