- Merck & Co. (Rahway, NJ)
- …minimal guidance of the Executive Director / Director /Associate Director , Pharmacovigilance (PV) Partner Strategy & Management (PV-PSM), the ... appropriate and complete.- Assesses the requirements and liaises within the Pharmacovigilance Operations team to ensure appropriate data and/or algorithms are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the ... Senior Director , GMA Oncology ADC (Global Medical Affairs team lead...information and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for managing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in one or several programs. Partner and collaborate with RD leaders in Clinical Operations , Biostatistics and Data Management , Regulatory Affairs, and other ... to Group Heads in Clinical Development, Asset & Portfolio Management , Global Clinical Operations , BDM and DLT...collaboration with GCLs, Physician Scientists and the study team ( data management , clinical operation and other functions)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the following areas/ SAP Finance modules: Asset Management , General Ledger, Travel Management , Master Data , Procure to Pay, Invoice to Pay, Project Systems, ... Material Management , Production Planning, Logistics, Sample Allocation Management Functionality, Master Data , Reporting, Integration/Interface monitoring and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …mentors and may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional ... in support of business objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets, EU and US Documentation: As the project lead, Independently… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... drug products consistent with the company goals; specifically, for the life-cycle management of NDAs/BLAs. This individual will be responsible for working on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Ensure close collaboration with other functional areas such as biostatistics, data management , clinical operations , pharmacovigilance, regulatory affairs, ... ADaM data set specifications, reviewer's guides, etc.- Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance ... complies with all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across the RA function… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …include: Clinical Operations , Clinical Development, Biostatistics and Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical ... Safety and Pharmacovigilance, Regulatory/Risk Management , Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project … more
- Merck & Co. (Rahway, NJ)
- …and save lives of women with breast and gynecological cancers.Associate Director Global Oncology Marketing Women's Cancer Portfolio Key responsibilities: Develops ... working and governance teams (launch readiness reviews, identification of data gaps and approaches, organized customer interactions, market research, demand,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …include: Clinical Operations , Clinical Development, Biostatistics and Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical ... Safety and Pharmacovigilance, Regulatory/Risk Management , Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services Project … more
- Merck & Co. (Rahway, NJ)
- …in public disclosure of clinical trials and their results, document disclosure, and data sharing with external researchers. The Executive Director in Medical ... Writing will be responsible for overseeing clinical trial data registration, results postings, redaction operations , external data sharing, and authoring lay… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: ... Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC,...clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... compliance mindset and collaboration with various partners and stakeholders in development.The Director will report to the Executive Director of Biologics and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global) for given commodities/business areas and leading the overall supplier relationship management program for DSI, for DS products and alliances. Cultivates a ... to develop and deliver processes, training, procurement technology and knowledge management tools. Closely partners with senior Business stakeholders to design… more
- Merck & Co. (Rahway, NJ)
- …, Consulting, Organizational Structures, Stakeholder Engagement, Stakeholder Management , Stakeholder Relationship ManagementPreferred Skills: Data Analysis, ... are seeking a dynamic and visionary leader for the role of Associate Director , Community Exchange Manager. This person will be responsible for building strong… more
- Merck & Co. (Rahway, NJ)
- …cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for ... of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... talent development, and partnering to build a culture of innovation and inclusion.-The Director reports to the Executive Director , Cell Based Sciences and will… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe role of Director , Global Communications, Oncology is a unique opportunity to join our company, a recognized leader in oncology, as a key member of ... this role will work under the guidance of the Executive Director , Global Oncology Communications, in a fast-paced and ever-changing environment.-Responsibilities… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Director - Immunology Competitive Intelligence Immunology Competitive Intelligence Associate DirectorUnder the ... supervision of Executive Director , the individual will be responsible for providing Competitive...Partnering with key stakeholders, individual will benchmark competitor clinical data , business models and capabilities to develop insights and… more
