- Novo Nordisk Inc. (Plainsboro, NJ)
- … regulatory agencies. Supervise designated personnel. Relationships Report to the Director/ Associate Director/ Lead Regulatory Scientist/ Sr . Manager ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Aequor (Newbury Park, CA)
- …affairs processes and deliverables. Works under under the direction of a Global or US Regulatory Lead or Manager and will assist in the creation and submission ... zone based on business needs in the evenings. Ideal Candidate: Previous Regulatory Experience professionally is highly preferred. Knowledge of FDA. Degree in life… more
- Aequor (Newbury Park, CA)
- …needed tasks, which requires resourcefulness and critical thinking skills.) Job Title: Sr . Associate - Records Information Management & Systems (RIMS)Job ... Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Work with stakeholders to gather requirements and develop solutions.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director ( Sr . Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site Digital Technology Lead is the representative for Global ... and Business support at the Millsboro site. The Site Digital Technology Lead ensures all project and commercial manufacturing activities are supported and delivered… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …based on the project needs and the respective development stage of the project. The CMC Lead will support the Sr . CMC Lead on complex and/or late-stage ... and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status... teams within overall CMC development project(s), to support Sr CMC Lead . In case no … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... clinical trial performance and quality metrics and share with study team, Operations Program Lead , and Sr . Director for the compound, on regular basis and ensure… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Technician, MaintenanceThe Senior Maintenance Technician is responsible for providing equipment troubleshooting and ... Quality, Automation, Technology, and other groups as required.The Lab Senior Maintenance Technician will provide maintenance supporting vaccine process equipment… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Fermentation Operations Technician (Days) This position is in direct support of our Upstream Fermentation manufacturing ... Filtration, Process Monitoring, Sampling, and area cleaning. As a Senior Technician you will be an energetic leader with...the manufacturing process. Individual will possess the ability to lead a small team, train others and contribute to… 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. ... suites coming online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain management including,… more
- Merck & Co. (Boston, MA)
- Job DescriptionThe Associate Vice President (AVP)/Therapeutic Area Head, Immunology Translational Medicine, will be responsible for leading the Translational ... own Immunology strategy with other TA Heads (Discovery/Late-Stage Clinical Development). Lead key technical reviews for Immunology assets.Conduct DRC reviews.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP) will be responsible for leading the Translational Medicine (TMed) Cardiovascular & Respiratory Therapeutic Area and ... own Cardiovascular & Respiratory strategy with other TA Heads (Discovery/Late-Stage) Lead key technical reviews for Cardiovascular & Respiratory assets Conduct DRC… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Co- Lead Deviation Investigations: Collaborate closely with the Quality Associate Director to co- lead the deviation investigations management system. ... in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical… 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 ... teams on vendor selection and management options in alignment with global strategies. Lead the process of Request for Proposal (RFP) development through supplier… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SUMMARYThe Associate Director, Pharmacoepidemiology position provides epidemiologic, methodological, and analytic ... analysis of epidemiologic studies, including real-word evidence (RWE), supporting senior management in various epidemiological activities.This position independently carries… more
- Insmed Incorporated (Bridgewater, NJ)
- …the reinforcement and ongoing growth of our culture. This position will report to the Senior Director, HCP and Payer Lead . This position does not have any direct ... in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director, HCP Marketing will be a key member...develop plans and utilize appropriate tools and tactics to lead HCP personal and non-personal brand initiatives. As with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality check… 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
- AbbVie (Madison, NJ)
- …with multiple driver indications within a Therapeutic Area and support the Manager, Global Regulatory Lead (GRL), Associate Director, or Director, in the ... on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager, Global Regulatory Strategy, US & Canada, AbbVie Inc., Madison / Florham… more
