- 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 ... Job Description Job Description: - The drug development Project Manager is part of Global Project...of our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core… more
- Insmed Incorporated (New York, NY)
- …and ancillary healthcare professionals regarding current and future therapies in development or commercialized by Insmed Works closely with Insmed personnel to ... and deliver HCP derived scientific insights to Insmed.Support research and development programs as requested by R&D, Clinical Operations, and Medical Affairs… more
- Merck & Co. (Rahway, NJ)
- …Description Position Description: The Office of General Counsel is seeking an Associate Director , Trademark Operations to provide docketing and legal operations ... specialized reports upon requestLeverage cross-functional relationships to influence the development and adoption of new processes/technologies to make a significant… 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)
- …financial evaluation, and business development activity for their business area.-The Associate Director is part of a team that partners closely with ... Job DescriptionThe Associate Director is a member of...Neuroscience Portfolio including alliance support, profit/cost sharing and business development modeling.- Within HIV, this role will be responsible… more
- Merck & Co. (Rahway, NJ)
- …build and lead a team of TA dedicated global and regional directors and associate directors. The Executive Director , Value & Implementation (referred to as EDMA) ... Job DescriptionThe Executive Director , Value & Implementation (V&I), Global Medical and...Medical and Scientific Affairs (GMSA) is accountable for the development and execution of scientific & medical affairs plans… more
- Merck & Co. (Rahway, NJ)
- …activities involving investigational compounds in Immunology. With a focus on late-stage development , the Executive Clinical Director will manage the entire ... in internal and joint internal/external research project teams relevant to the development of new compounds The Executive Clinical Director may: Oversee… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company's Device Product & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/drug/vaccine - device enabled ... delivery to their intended site of action.- The DPPD Team manages the development of the device constituent of our company's pipeline of combination products across… more
- Merck & Co. (Rahway, NJ)
- …healthcare. The Biologics and Biopharmaceutics team is responsible for the research and development of sterile & parenteral drug products for biologics as well as ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and ... and timelines and that quality of data is suitable for regulatory submission.The Associate Director will have routine interaction with key internal and external… 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
- 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 ... decisions where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong organization and interpersonal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) ... may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU....may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.Ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under guidance ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to ... under some supervision to solve complex study problems. Responsibilities Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP),… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The project teams will be defined based on the project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on ... Responsibilities - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case...strategies and activities for early and late phase drug development candidates within the team to support overall CMC… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Associate Director , Global Business Process Manager, Global DX is responsible ... transformation and automation across the organization. Responsibilities Process Design, Development , and Optimization:- Coordinate and lead the conception, design,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Responsibilities:- Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP), ... (CSR): Leads statistical activities for complex studies including study design, protocol development , CRF review, SAP development , analysis files development… more
- Merck & Co. (Rahway, NJ)
- …and applying rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director ) and Product Development Team (PDT) lead, Oncology Global ... in the execution of clinical studies.--Will report and work collaboratively with the- Associate Vice President to promote the development strategy of the company… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …implement effective regulatory strategies to deliver on efficient and robust development plans. The individual will direct, coordinate and implement the preparation ... requests, orphan drug applications.Participate in global product team meetings ( development and marketed products); provide regulatory support and guidance and… more
