- 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 ... collaboration with the Global Regulatory Lead(s) on a compound in late-stage development to implement the US regulatory strategy for multiple new indications. You… 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...regulatory submissions, and recruitmentBudget and PlanningAssist in the initial development and management of the trial budgetPlan, implement, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the head of Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... 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… 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 ... About the Department Our East Coast Global Development Hub brings together the best minds in...functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve… 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 of new trials. The role will include responsibilities in - and is not… more
- Genmab (Plainsboro, NJ)
- …our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for leading the development and maintenance ... Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be...and guidance as they relate to global labelingUnderstanding of clinical development of novel biologics products, preferably… more
- 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 ... clinical trials. The ideal candidate will be responsible for overseeing the development and maintenance of clinical databases and ensuring the integrity,… more
- Merck & Co. (Rahway, NJ)
- …Oncology medicines. Our Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the ... diseases. --The Director will report to an Associate Vice President in the Oncology Clinical ...affairs, statistics, and manufacturing to manage clinical development projects; and Assist the Senior/Executive Director /AVP… more
- Merck & Co. (Rahway, NJ)
- …Clinical Supply Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the ... development process & connectivity between functions supporting pipeline (ie clinical development , Compound Management Coordination , supply chain, & human… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferredDaiichi Sankyo, Inc. is an equal opportunity/affirmative action ... around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global … more
- Merck & Co. (Rahway, NJ)
- …of Associate Director QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related ... effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will...Serving as an expert representative for QP2-IO on Oncology clinical development teams. Framing critical questions for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… 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 ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… more
- Merck & Co. (Rahway, NJ)
- …the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive ... of our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core...MBA, Ph.D., PharmD) preferred - Experience and knowledge of clinical drug development strongly preferred; including the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small ... with small molecules, biologics, and vaccinesBroad understanding of drug discovery, development and research, clinical data coding and experience working… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …- Project Planning and Forecasting - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase ... I-III clinical studies.Partner with Project Management, Clinical Operations and other functional groups to ensure budgets...Budget Planning - Manages and is accountable for the development and control of functional budget in support of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for ... and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… more
- Merck & Co. (Rahway, NJ)
- …affairs, statistics, medical affairs and manufacturing to manage clinical development projects; and assist the Associate Vice President in ensuring ... and ethical standards.-The Distinguished Scientist (Executive Director ) and Product Development Team (PDT) lead, Oncology Global Clinical Development ,… more
- Merck & Co. (Rahway, NJ)
- …and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and ... research opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust… more
