- Merck & Co. (Rahway, NJ)
- …of decision-making at ouor company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an...Associate Director will work with scientists within QP2 by applying… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas ... the Technical Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Represent Device Development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department At Novo Nordisk, our Finance and Operations team is the engine that elevates holistic commercialization of our products. The Finance and ... Operations team works closely with the business across the...in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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...and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling… 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 of 6-8 ... IT to resolve critical incidents resulting in significant impact to business operations and finance month end close.Provide functional leadership and guidance to the… more
- Eisai, Inc (Nutley, NJ)
- …to the broader EIT organization such as Infrastructure teams, Architects and IT Operations . Partner with ITQA, Business Owner and IT Project Manager for defining a ... with/using the following (which may have been gained concurrently): Supporting Regulatory and/or Safety functions in a global environment; Supporting Regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …protocol timelines; considers relevant input and guidance to other areas within NACD including Operations Director and TA Heads End to End Supply Operations ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder management: Build strong internal… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related ... development.#LI-TS1Eisai Salary Transparency Language:The base salary range for the Associate Director , Clinical Outsourcing is from :157,200-206,300Under… more
- Merck & Co. (Millsboro, DE)
- …Millsboro Delaware seeks to add an Attending Veterinarian in the role of Associate Director .This position will have overall responsibility for oversight and ... DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, 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
- Merck & Co. (Rahway, NJ)
- …recognized internal management consulting team within Medical Operations , driving strategic, large-scale, cross-functional initiatives.Responsibilities:Support the ... of the pharmaceutical/Life Sciences industry, including an understanding of regulatory requirements and industry trendsExperience as a consultant, preferably with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and management of the resources within NACD. Relationships Reports to Snr Director of Clinical Strategy and Business Operations within Operational Excellence ... include: Finance, North America Clinical Development (NACD) Clinical Medical & Regulatory (CMR), Future Business Strategy (FBS), Strategic Operations (SO,… more
- Merck & Co. (Rahway, NJ)
- …on a variety of Quality or compliance-related issues.Interprets complex regulatory requirements for various audiences, including source area management, and ... in face-to-face meetings, then your employment may pose an undue burden to business operations , in which case you may not be offered employment, or your employment… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the ... providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. This position may propose strategies for external data… more
- Catalent (Harman, WV)
- Senior Director , Supply Chain Position Summary: The Senior Director , Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... coming online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain management including, but… more
- Insmed Incorporated (Bridgewater, NJ)
- …and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations , non-clinical safety, contract research organizations etc.) to build ... in preclinical study design and documentation as needed.Contribute to regulatory document writing (eg IB, IND, Integrated Summary of Immunogenicity).Engage… more
- Merck & Co. (North Wales, PA)
- …cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be ... statistics, and manufacturing to manage clinical development projects; andAssist the Senior Director , Executive Director , and/or Associate Vice President in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to collaborate with, and support the head of Global QA strategy and operations . In this position, the incumbent will take on organizational responsibilities relevant ... tasked under the direction of the Global Strategy and Operations Head, to draft presentation for VP of QA,...to individuals are current and up to date- Support regulatory inspection related activities as required- Support Head, Global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... functional teams and various departments to include Marketing, Medical Affairs, Regulatory Affairs, Supply Chain Technical Operations , Pharmaceutical Technology… more