- 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)
- …other research areas centered around rare diseases and immune disorders. Summary The Senior Director, Head Global PV Quality (DSI/DSE) reports to the Global Head ... RDPVQA, and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global PV Quality teams… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities related to ... procedures, and regulations, for their assigned TA. The AD partners with senior colleagues in developing and implementing improvements in medical review processes… 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
- 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
- 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
- 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. (Rahway, NJ)
- Job DescriptionUnder minimal guidance of the Senior Director or Director, Business Development Execution, the primary function includes coordinating various GRACS ... functional areas, to ensure implementation and maintenance of regulatory activities associated with assigned Company Business Development (BD) Agreements.- These… more
- Merck & Co. (Rahway, NJ)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing ... clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality Operations, the Clinical Quality… more
- Merck & Co. (Rahway, NJ)
- …are seeking a highly skilled and experienced professional to join our team as an Associate Director for our Digital Forensics Lab. The Associate Director will be ... all activities are conducted efficiently and in compliance with legal and regulatory requirements. Manage and provide technical guidance to a team of digital… 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
- 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
- Novo Nordisk (Princeton, NJ)
- …decision-makers across multiple functional areas. Relationships You will report to the Senior Director, Global Regulatory Portfolio Lead . Essential Functions ... expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies for… more
- Novo Nordisk (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
- Elevance Health (Morristown, NJ)
- **Managing Associate General Counsel, Sr (Deputy General Counsel) - Data Governance, Information Security and Privacy** **Location** Successful candidate must ... support the Company's most important business strategies, goals, and objectives. + Lead and design processes to manage data rights, privacy, cybersecurity, and data… more
- Bristol Myers Squibb (Princeton, NJ)
- …and adapting best practices and maintaining rigor in light of emerging regulatory guidelines for mechanistic modeling, mentoring modelers on the methods and ... model sensitivity analysis, and prediction uncertainty characterization + Advance existing and lead development of new tools that can be deployed using parallel… more
- Lilly (Branchburg, NJ)
- …and departments. Participate in audits performed by partners, Lilly corporate, and/or regulatory agencies, as applicable. Identify and lead process improvement ... (materials management, warehouse etc.) by conducting periodic walkthroughs. Ensures regulatory compliance and procedural consistency between manufacturing facilities. Prepares… more
- Pfizer (Parsippany, NJ)
- …but will often act under the support and direction of the Senior Manager, Cybersecurity Network Protection Lead : + Analyze business requirements ... and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's...disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of… more
