- 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 ... manage cross-functional study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met according to… more
- Merck & Co. (North Wales, PA)
- …of clinical data/medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members ... position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will collaborate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Oversees typically ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research , ICH GCP Principles and the application of those ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Merck & Co. (North Wales, PA)
- …Management Office (PMO), and Administrative Professionals.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of ... DescriptionGlobal Project and Alliance Management (GPAM) sits in the Research & Division organization of our company. GPAM comprises...the R&D pipeline and realize its full potential. The Associate Director is expected to provide project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Position supports ... safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The Technology ... 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. (North Wales, PA)
- …professional development, and performance management Core Skills Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH)Proven ability ... the operational planning and execution of one or more clinical trials. In this position, you will have the...collaboration with external stakeholders, such as customer-facing commercial, or research -based roles, will be expected to comply not only… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Director will report directly to the US Marketing Leader for New Products and play a critical role in the US commercial development ... marketing, medical affairs, outcomes research , market research , global market access , and clinical ....market research , global market access , and clinical . Lead the collection of customer insights and engage… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Marketing, Training, Market Access, Trade, Legal, Compliance, Finance, HEOR, and Market Research . The position has high exposure to senior management and requires a ... independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships include… 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 ... collaboratively with multiple functional teams including Market Access, Medical, Market Research , Human Health Digital Data & Analytics (HHDDA), Human Health… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ResponsibilitiesProvide outstanding leadership skills based on a sound knowledge of clinical research standards and GCP.Develop operational strategies for ... research areas centered around rare diseases and immune disorders.SummaryThe Senior Director of Clinical Operations will manage clinical operations staff… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis position is ... and is accountable for the development and control of Clinical Project Budget in support of Phase I-III ...Clinical Project Budget in support of Phase I-III clinical studies. Partner with Project Management, Clinical … 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, ... protocols.This position independently manages relationships with internal (CSPV, Regulatory, Clinical , Medical Affairs, HEOR and other stakeholders to ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …value creation Understand the Novo Nordisk value chain, eg, corporate development, research , clinical development, manufacturing and commercial operations to be ... to realize your potential? The Position To support the Director of US Tax Operations in leading and managing...personnel at NNI and all US affiliates including commercial, research , corporate development, and manufacturing sites. Serves as a… more
- Merck & Co. (North Wales, PA)
- …and manufacturing to manage clinical development projects; andAssist the Senior Director , Executive Director , and/or Associate Vice President in ensuring ... with talented and dedicated colleagues while developing and expanding your career.The Clinical Director (Principal Scientist) has primary responsibility for the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The purpose ... 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)
- … research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop ... for the assigned oncology asset(s). This person will report to the Sr Director , Global Oncology Value Pricing & Access, and will be responsible for providing… more
