- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Daiichi Sankyo Pharmacovigilance Safety Systems, and fulfillment of data change requests.Responsibilities- Change Requests for PV Systems :Collaborate cross ... definition, process design, solution design, test planning and execution, data readiness, cutover planning and execution, and post-go-live supportAdvocate change… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Development on Project Teams. Responsibilities Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data ... appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leads and Regulatory Liaisons to ensure successful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of ... documents supporting CDx submissions to the FDA and other health authorities globallyFor late-stage programs, executes the Diagnostic development strategy for a project under the direction of the GPT CDx representative while keeping abreast of regulatory and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings.Review and interpret regulatory guidelinesContinuing Education: ... Keep current with regulations and guidance documents; attend meetings, seminars, conferences on relevant topics; read journals, newsletters, scientific papers; research the answers to RA questions. Qualifications: Successful candidates will be able to meet the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …downstream applications.Provide expertise on best practices, system integrations, data migrations, and technical configurations.Stay updated on industry trends, ... incorporating relevant advancements to optimize system performance and functionality.- Data Quality, Testing and Release ManagementEstablish and enforce robust … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …minutes, and communicate materials, in support of the PSL. Independently evaluates safety data of any source to identify potential safety signals and performs safety ... development of the Safety Management Plan for assigned product(s)Independently evaluates safety data of any source to identify potential safety signals and performs… 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 ... all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across...either the US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in class sourcing and procurement for Global RD - for their specific categories.- Data Analysis Based Decision-Making- Uses rigorous analyses of data as well as ... knowledge of clinical trials preferred- Demonstrated ability to leverage digital data and analytics preferred- Demonstrated ability driving or participating in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .Drug Development Strategy: Provides ... input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review CRO/vendor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the category strategies. Proactively uncovers insights and value from all Category data to identify new areas of opportunity for additional sourcing value and ... helps influence and inform budgeting decisions by the Business and the utilization of suppliers.- Serve as the Project Management Owner for DSI's overall Supplier Relationship Management Program (SRM) with Tier 1 suppliers which includes robust comprehensive… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , Business Analyst, within Metrics, Analytics & Performance (MAP) will lead activities related to the development, delivery, ... of dashboards/reports according to established plan.Leads the analysis and interpretation of data to support the ability of internal customers to successfully carry… more
- Merck & Co. (Rahway, NJ)
- …corporate priority and expected to be a key growth driver for our company.The Associate Director , Healthcare Consumer (HCC) / Patient Strategy - Global Marketing ... broadly with cross-functional partners to support enterprise-wide commercialization preparedness.--The Associate Director will play an important role in… more
- Merck & Co. (Rahway, NJ)
- … data /medical protocol deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members through proactive ... analytical skills with the ability to interpret clinical trial data and synthesize conclusionsInteract with key stakeholders across department, division,… more
- Merck & Co. (Rahway, NJ)
- …Preventive Actions (CAPA)s which are necessary due to audit findings.Assure maintenance of audit data in a related data system (incl. reports and follow-up of ... audits)Co-ordinate the planning of PV Audit training sessions, and compilation of PV Audit Risk Assessments (eg, for Supplier Qualification)Support our company's Animal Health sites in their preparation for Regulatory Agency Inspections by conducting audits,… more
- Merck & Co. (Rahway, NJ)
- …and expected to be a key growth driver for our company.These three Associate Director roles, Healthcare Provider (HCP) Strategy, Scientific Strategy, and Go ... key growth driver for our Company. The roles report to the Executive Director , Strategy Lead and will collaborate broadly with cross-functional partners to support… more
- Merck & Co. (Rahway, NJ)
- …strong leader who is passionate about lab management and operation support. The Associate Director of Biologics Process Research and Development (BPR&D) is ... labs, and coordinating lab equipment preventive and corrective maintenance (PM/CM). The US Associate Director is also responsible for leading lab safety and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionA fantastic opportunity has arisen for an Associate Director Asset Management & Reliability CoE.Reporting to the Director , Asset Management & ... Reliability, in this role as Associate Director Asset Management & Reliability CoE, you will be responsible for overseeing Asset Management and Reliability… more
- Merck & Co. (Rahway, NJ)
- …design and implementation of cutting-edge data solutions. - As the Associate Director - Technical Product Manager for the Cross-Divisional Marketplace ... Technical Product Manager to lead and drive our enterprise-wide data marketplace initiatives. The ideal candidate will bring deep...Program, you will be at the forefront of our data marketplace initiatives, working closely with senior leaders and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Director , Clinical Scientist This position drives scientific planning, strategy and execution of Phase 1-4 ... up)Lead medical monitoring team in review and interpretation of clinical data /medical protocol-deviations in collaboration with the Clinical Director .Builds… more
- Merck & Co. (Rahway, NJ)
- …to the Director , Asset Management & Reliability, in this role as Associate Director Asset Management & Reliability CoE, you will be responsible for ... External Manufacturing Operations within a designated region in the Manufacturing Division.As Associate Director of Asset Management & Reliability CoE you will… more
