- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for supporting the Head, Program Management & Operational Excellence, the assigned Global Medical Affairs Team (GMAT) or Functional Lead , and the Franchise ... prioritization and planning of resources and develop rationale for annual resource planning. Lead issue resolution meetings. Lead risk identification,… more
- Genmab (Plainsboro, NJ)
- …and ongoing oversight of Genmab data processors in accordance with Genmab's risk management framework and data privacy and protection policies.Works closely ... to fulfilling our purpose.The Role.The Director, Privacy Technologist & Third-Party Privacy Risk reporting into the Head of Global Data Privacy Program,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is accountable for partnering with the Global Team leader as the Project Management lead on drug development projects. This position can be assigned to any ... team members.Maintains global integrated project plans, project timelines, risk management plans and communication plans. Resolves complex problems… more
- Genmab (Plainsboro, NJ)
- …60% of the time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs, the key responsibilities ... for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be primarily… more
- Insmed Incorporated (San Diego, CA)
- …the Senior Director will be responsible globally for executing the safety and risk management activities. This individual is responsible for safety surveillance, ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the... risk management , and risk communication for… more
- Merck & Co. (Rahway, NJ)
- …as Content Lead for one or more GPV sub-teams (eg, training, risk management , procedure management ):Establish team priorities and allocate resources ... Job DescriptionThe Senior Specialist, Global Pharmacovigilance will be responsible for some or...product activated in PV-Works to the applicable product familyRisk management for assigned productsParticipation in signal management … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …respect to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...Lead is established, take main responsibility for CMC lead . Provide operational coordination and management to… more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical ... engineering design, engineering analysis and testing, medical device design controls, risk management , test method/fixture development, design verification and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well ... Are you ready to realize your potential? The Position This position will lead a team of Validation Engineers and Validation Technicians, and is responsible for… more
- Merck & Co. (Rahway, NJ)
- …country program rollout with cross divisional and market stakeholdersStrategic thinking, risk management , and roadmap planning for data product evolutionEnsure ... role, you will be part of the HHDDA Commercial Data Solutions team and lead Digital Product Management capabilities role, driving shaping and delivery of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and ... Phase 3/4 program.This position identifies and selects resources/tools to facilitate risk management during development and post-market. Additionally, this… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards ... in fast-paced environment, continuous improvement, project management , change management , and risk management .Responsibilities:Leadership, Direction, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and application and other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and study-level critical ... globally and with external parties as required.Champions 'Quality by Design' and Quality Risk Management approaches to quality management within Daiichi… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Operations on the DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place for all ... of the overall development plan agreed to by the Global Project Team (GPT). Lead site selection and...Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification and Management Log (RIM Log)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are ... collaboration with the Global RD/PV QA team.RESPONSIBLITIESProgram oversight: Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs) by… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for overall product safety strategy or specific areas of safety surveillance and risk management , and provide safety leadership including but not limited to ... topics, and regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor selection process in collaboration with the study team and outsourcing procurement management . Lead the creation of the CRO scope of work in collaboration ... with Outsourcing Procurement Management . Lead trial feasibility and site identification activities...and relevant governance bodies.Triage, resolve or escalate study issues / risk mitigations to the Operations Program Lead … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Headquarter to support with routine and unusual issues related with Global Products.ResponsibilitiesQuality Management System (QMS): Ensures and support that ... experience dealing with multinational drug regulators.Demonstrated understanding of quality management and continuous process improvement principles including global… more
- Merck & Co. (Rahway, NJ)
- …devices and combination products globally.- Experience in design controls, device risk management , medical device, complex combination product kits, prefilled ... be expected to function as an independent contributor, supporting global and site-specific projects, including those related to Combination...to our Company strategy and business goals- Utilize device risk management tools to build device or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …brand activities. Secure global funding and assess progress during pre-launch Risk Management : Proactively raises risks within the brand/launch plan to brand ... individual will have a proven track record in program management , coupled with expertise in launch excellence methodologies and...business growth and success. Relationship Reports to Launch Excellence Lead and dotted line to TA Integrated Lead… more
