- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... regulatory expertise on IVDR. This person will develop regulatory strategy and provide input on IVDR...side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist… more
- Merck & Co. (Rahway, NJ)
- … therapeutic area and team leading to global innovative and accelerated regulatory strategy and marketing authorizations for: Cardiovascular & Respiratory, ... activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy .Providing quality advice to… more
- Merck & Co. (Rahway, NJ)
- …through-tactics) Synthesize information from market research outputs to develop portfolio strategy - Execute GRL interviews to begin change management process ... Job Description Portfolio Customer Experience Execution & Day-to-Day Management : Develop guidance and tools to scale tumor team franchise strategies across multiple… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …project management , change management , and risk management . Responsibilities Leadership, Direction, and Strategy :Establishes Data Management ... and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the respective PV inspections in alignment with regulatory and company strategy .Act as the management representative for all key health authority inspections ... impacting products from a quality perspective. Provide updates to management on MTP strategy for PV QA...the GvP modules in support of a proactive quality risk management process.Interact with the audit and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …On-Prem, Service Provider Outsourcing). Contribute to the Daiichi Sankyo validation strategy by considering regulatory requirements, industry best practices and ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …continuous improvement, project management , change management , and risk management . ResponsibilitiesLeadership, Direction, and Strategy :Provides data ... project team regarding the data management DM activities and deliverablesEstablishes Data Management strategy at the project and/or study level for a larger… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …overall product safety strategy or specific areas of safety surveillance and risk management , and provide safety leadership including but not limited to ... regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Oncology Clinical Development, an organization dedicated to the effective strategy , design, execution, and interpretation of Oncology clinical trials. Position ... of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1 -… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory / Risk Management , Quality Assurance, Medical Affairs, ... Translational Research, Research, Informatics Services Project Management and Operational Management .Develop a strong, positive strategic business partnership… more
- Eisai, Inc (Nutley, NJ)
- …stakeholders from EIT and leaders across regions in Compliance, Ethics, Risk Management , Legal, Data Privacy, and Information Protection.Security ... key stakeholders.Coordinate audit readiness and resolution.Align IT compliance budget with risk appetite and global strategy .Educate end-users on IT compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position will require proven skills in continuous improvement, project management , change management , and risk management . The position will act as main ... the development of study protocol (design, sample size, statistical analysis strategy ); Review CRF; Write SAP; Manage statistical analysis outputs with programming… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit ... data in context of broader process and product development, control strategy , and specifications-setting.-Deep working knowledge of regulatory guidance and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal ... written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …respect to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions ... established, take main responsibility for CMC lead. Provide operational coordination and management to drive strategies and activities for early and late phase drug… more
- Merck & Co. (Rahway, NJ)
- …purpose of the Global Labeling Therapeutic Area group is to drive labeling strategy and ensure high-quality and compliant labeling documents, which provide the safe ... CCDS, CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling and other… more
- Merck & Co. (Rahway, NJ)
- …processes and procedures (internal and external).Working knowledge of design controls and risk management processes for medical devices and combination products, ... including establishment of design inputs, design outputs, design verification, and risk management integration. Expertise in testing, characterization, and… more
- Merck & Co. (Rahway, NJ)
- …for non-sterile and sterile products.- It also includes strategic partnering with CMC and Regulatory in aspects of control strategy and filings, Quality, and our ... filings.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary.Maintaining an… more
- Merck & Co. (Rahway, NJ)
- …(including the CTC, CRAs and-COM).-Responsible for creating and executing a local risk management plan for assigned studies.Ensures compliance with CTMS, eTMF ... role is primarily accountable for the end-to-end performance and project management for-assigned protocols in a country in compliance with International Conference… more
- Merck & Co. (Rahway, NJ)
- …will be responsible for developing and leading the digital pathology strategy , market development, and global commercialization of digital pathology algorithm tools ... internal stakeholders across HH, our Research & Development Division, Medical Affairs, Regulatory , Legal etc. as well as external partners (diagnostic & device… more
