- Merck & Co. (Rahway, NJ)
- …filings.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary.Maintaining an ... network to enable process and formulation development.- In this position the SMAR&D Director will set guidance, lead activities, and develop a team whose roles… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing… more
- Merck & Co. (Rahway, NJ)
- …Development. -The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit ... accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study ... planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the... of data is suitable for regulatory submission.The Associate Director will have routine interaction with key internal and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …communication, planning and management of schedule, budget, scope, issue risk management , and quality /outcomes. Communication: Ensure that assigned ... initiative is on track and adheres to the strategic goals. Issue and Risk management and reporting: Ensure that assigned PMs identify and manage issues and risks… more
- Genmab (Plainsboro, NJ)
- …their skills and knowledge on process management & improvement, strategic & risk management planning, change management and stakeholder management . ... is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director , Global Clinical Drug Supply to be part of Global Clinical Drug Supply… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Rahway, NJ)
- …and maintaining efficient, effective, and compliant business standards, process maps, and risk management for global processes across Global Regulatory Affairs ... Safety , including training process standards and strategies to ensure optimal quality and compliance in Global Regulatory Affairs and Clinical Safety business… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …conduct is completed in compliance and meets Novo Nordisk's business standards Risk Management : Assessing and mitigating risks associated with operations, ... a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder Management : Build strong internal and external… more
- Merck & Co. (North Wales, PA)
- …overseeing all PV processes, including adverse event reporting, signal detection, and risk management activities.-Manage PV systems: Responsible for managing PV ... Case Intake and Processing. Reporting into Product Line Lead Patient Safety and Quality & Compliance, this position will be responsible for managing the development… more
- Merck & Co. (Rahway, NJ)
- …with cross-functional teams, manufacturing sites, clinical safety and risk management to uphold the highest quality standards and drive innovation ... Job DescriptionThe Senior Director of Device Product Stewardship will lead a...rigorous technical support processes to support manufacturing sites, proactive risk management , performance monitoring, continuous improvement activities… 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 ... smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global PV regulations for individual case safety reporting, periodic reporting and risk management . Develops and implements strategic initiatives for global ... around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and contracts including… 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
- Merck & Co. (Lower Gwynedd, PA)
- …Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late Development (AdVAnce) ... and enable late-stage clinical trials through the generation of timely, high- quality regulated bioanalytical data. A combination of molecular (eg, PCR), serology… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance, Medical ... projects to ensure homogeneity within IT and supports oversight and management of integrations solution design, implementation strategy and requirements gathering,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all Strategic Sourcing efforts through to final contract, including project management , supply analysis, supplier identification, risk mitigation, sourcing ... Global) for given commodities/business areas and leading the overall supplier relationship management program for DSI, for DS products and alliances. Cultivates a… more
- Twist BioScience (South San Francisco, CA)
- …with Tech industry and public accounting experience. The role will report to the Sr. Director of Internal Audit and be part of the internal audit team under the CFO ... will have a proven track record of audit project management and SOX 404 compliance. You are strong in...SOX stakeholder groups in driving and coordinating audit requirements.Support risk assessments, planning, execution and reporting of SOX and… more
- Novo Nordisk Inc. (Boulder, CO)
- …ability to interpret and apply regulations to complex issues to make risk management recommendations Ability to manage people and competing priorities ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a fast-paced environment, continuous improvement, project management , change management , and risk management .Responsibilities:Leadership, Direction, and ... teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality coding deliverables are on time to support drug development processes and… more
