- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in supporting ... the pharm and vaccine veterinary clinical trials. The ideal candidate will be responsible for...be responsible for overseeing the development and maintenance of clinical databases and ensuring the integrity, consistency, and confidentiality… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company ... Research Laboratories portfolio of clinical trials.- Global Clinical Supply is accountable for the planning, sourcing, labeling, packaging and delivery of … more
- Insmed Incorporated (New York, NY)
- …a local medical and scientific resource to Insmed for product planning, clinical insights, and intelligence. Capture, synthesize and deliver HCP derived scientific ... insights to Insmed.Support research and development programs as requested by R&D, Clinical Operations, and Medical Affairs Departments. This may include trial site… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a ... single or multiple clinical trials from strategy outline through to CSR by...outline through to CSR by leading cross-functional trial specific Clinical Trial Teams (CTT) to deliver clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position works with the Director, Clinical Study Startup to establish the strategy driving global Clinical Study ... provides input on electronic data capture (EDC) Safety report outputs, reviews clinical study and post-marketing protocols and the Clinical Study Oversight… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Merck & Co. (Rahway, NJ)
- …execution of clinical studies.--Will report and work collaboratively with the- Associate Vice President to promote the development strategy of the company on the ... commercialization, regulatory affairs, statistics, medical affairs and manufacturing to manage clinical development projects; and assist the Associate Vice… more
- Merck & Co. (Rahway, NJ)
- …in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projectsAssist the Senior Director, Associate ... Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for...has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. With… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director, Global Regulatory Affairs, Regulatory Strategy to be a part of ... US RA in the Global Regulatory Team, Labeling Working Groups, Launch Teams, Clinical Trial Teams, and other cross-functional teams as required for the assigned… 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 ... The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks related to final printed… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ... and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to make a difference? The Position Reporting to the head of Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...internal stakeholders. In the execution of specific projects, the Associate Director, will be accountable for managing relationships with… 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 ... a living. Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D ... to management and other internal stakeholders Perform regulatory review of all clinical and nonclinical documents for submissions, eg, clinical protocols and… more
- Merck & Co. (Rahway, NJ)
- …changes the way we approach serious diseases. --The Director will report to an Associate Vice President in the Oncology Clinical Research Group. Under the ... the Director has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our Oncology… more
- Merck & Co. (Rahway, NJ)
- …Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical ... organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration.… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The Role & DepartmentThe Associate Director, Vendor Management, will play a pivotal role in managing the ... relationships with the clinical vendors as well as coordinate and manage outsourcing...efficient and effective trial operations.Point of Contact for Global Clinical Trial Managers: Act as the primary point of… 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 ... strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.- The AVP provides strategic oversight for the early clinical … more
- Merck & Co. (Rahway, NJ)
- …company's biologics pipeline. We work closely with colleagues in Discovery, Pre- clinical and Early Development to rapidly develop manufacturing processes for diverse ... biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and development and… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs… more
