- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partner side) CDx RA Policy and Intelligence : Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these ... procedures.Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization… 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
- Eisai, Inc (Exton, PA)
- …Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge of established ... is your profile, we want to hear from you.The Associate Director of Biologics Operations Upstream and...for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of operations to… more
- Merck & Co. (San Francisco, CA)
- …of decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… more
- Merck & Co. (San Francisco, CA)
- …and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical Development organization and ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAbout the Role:-As a Technical Lead, you will report into Director , Chemical Technical Operations, External Manufacturing API Technology, and play a ... Review process change requests and deviation reports while ensuring regulatory compliance. Education and Minimum Requirements:Bachelor's degree in engineering,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director , has primary responsibility for ... development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in their HTA submissions. The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design pull you in? Are you ready to experiment with us? The Position The Associate Director - Launch Operations will play a pivotal role in guiding the ... to business growth and success. Relationships Reports to Executive Director Launch Excellence. Collaborates with cross-functional teams, including finance, HR,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines,- strategies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end ... 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
- Merck & Co. (Durham, NC)
- …Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division ( Associate Director ).-This role serves as a Virtual Plant Manager - ... contact for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a… more
- Merck & Co. (Rahway, NJ)
- …West Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and ophthalmology ... pipelines. - As an Associate Director , you will represent QP2 on...and interpretation of data. Maintain a comprehensive understanding of global regulatory expectations and shape, present and… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionOur company seeks to add an Associate Director . Veterinarian Services at our Millsboro, Delaware location. This position will have overall ... (USDA, DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThis Associate Director will report to the Site Quality Head/ Director … more
- Eisai, Inc (Nutley, NJ)
- …current regulations for those undertaking clinical studies.Job SummaryThe Associate Director , GCP Quality Assurance works within the Global Clinical Quality ... (approximately 25%)Eisai Salary Transparency Language:The base salary range for the Associate Director , Clinical Quality Assurance is from :159,500-209,400Under… 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 ... will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the necessary… more
- Genmab (NJ)
- …and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions ... across all phases of development.Partners with key stakeholders within Global Development Operations (GDO), Medical Affairs, Medical, and/or CROs, to… 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 ... of companion diagnostics (CDx) strategy in support of projects and Global Project Teams within Daiichi Sankyo's Early and Late-Stage Development Portfolio.… 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 ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… 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 ... effective vendor programming implementation, and expedite the preparation of regulatory submissions. Responsibilities include: make strategic programming decision 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 ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight:… more
