- 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 ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...within functions. Takes ownership to position & deliver upon strategic NACD goals, including those specifically aligned with the… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is responsible ... development and implementation of global publication strategies and tactical plans. The Associate Director Pub Manager oversees compliance with our company's… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical ... investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Quantitative Systems Pharmacology (QSP) will work within the ... Quantitative Clinical Pharmacology (QCP) group to develop and apply QSP...the development of complex models of biological pathways/systemsExperience with strategic application of QSP to address questions in Pharmaceutical… 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 ... ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and...This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that… more
- Insmed Incorporated (Bridgewater, NJ)
- …for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large ... bioanalytical methods and sample analyses of regulated bioanalytical assays for clinical , nonclinical and biomarkers studies. This translational role resides within… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position is primarily responsible for budgeting and forecasting, analysis, strategic planning, internal reporting, ad hoc reporting and analysis, and change ... and is accountable for the development and control of Clinical Project Budget in support of Phase I-III ...- Manages and is accountable for developing and building strategic planning and forecasting models in support of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships include ... and recommendations for management endorsement Insight Generation Identify and communicate strategic insights and trends in health plan coverage, competitive support… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Marketing Women's Cancers Associate Director is a vital role that will be responsible for shaping Women's Cancers indications across ... strategies. Lead the Commercial Excellence Framework (L3 Next) and associated strategic development in close collaboration with the Global Disease Lead.Lead and… more
- Merck & Co. (North Wales, PA)
- …the strategy and leads the operational planning and execution of one or more clinical trials. In this position, you will have the opportunity to demonstrate your ... management, communication, and collaboration skills in support of our clinical trials. Job Responsibilities Responsible for the operational planning, feasibility,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …plans at the site which are aligned with cross-functional CMC strategic discussions. Manage timelines, deliverables, and coordinate the input of technical ... gaps at the manufacturing sites.- Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. (mAb, Drug Substance, Drug… more
- Merck & Co. (Rahway, NJ)
- …the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical ... 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. (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to realize your potential? The Position To support the Director of US Tax Operations in leading and managing tax operations, tax compliance, ... with key stakeholders and developing self, team and organization. Relationships Reports to Director of US Tax Operations. Member of NNI Finance & Operations -… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and expedite the preparation of regulatory submissions. Responsibilities include: make strategic programming decision and planning, review Case Report Form (CRF) ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop ... oncology asset(s). This person will report to the Sr Director , Global Oncology Value Pricing & Access, and will...Pricing & Access, and will be responsible for providing strategic and technical expertise to drive the success of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …aligned therapeutic / franchise area(s). Relationships Reports to the Senior Director of Value Communication and Contracting Strategy Interacts frequently in ... management and senior level global stakeholders Interacts internally with Strategic Pricing & Contracting, Finance, Brands, Medical Affairs, HEOR, Commercial… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global ... those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Management to drive the establishment of expert capacity planning and analysis, strategic and scenario planning and use of various analytical tools. Analytical ... experience or equivalent required- Industry experience: Pharmaceutical, life science, clinical trials management, healthcare preferred- Project Management Professional (PMP)… more
