- Twist BioScience (South San Francisco, CA)
- To add to our growth, we are seeking an Internal Audit Project Sr Manager with Tech industry and public accounting experience. The role will report to the Sr . ... 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. (Plainsboro, NJ)
- …The Position This role directs and operationalizes NNI's Ethics & Compliance (E&C) risk management program by leading and managing four functional areas: ... a critical part in designing and driving the core risk management operations of the E&C team,...trends Collaborate with other departments to develop and implement risk mitigation strategies Lead the development and… 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 ... the respective development stage of the project. The CMC Lead will support the Sr . CMC ...and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status… more
- Merck & Co. (Rahway, NJ)
- …and global functions such as infrastructure, engineering, system security, risk management , etc.Education Requirement:-Bachelor's degree in automation, ... of the Research Automation Operations product (Laboratory and Plant) within RIPL. -As Sr . OT Infrastructure Specialist, you will lead the definition and… more
- Merck & Co. (Rahway, NJ)
- …Material(s):n/aRequired Skills:Measurement Analysis, Portfolio, Programme, and Project Support, Program Management , Risk Management , Stakeholder Relationship ... hierarchy both within and across organization.Candidate will join our Project Management Office (PMO) for one of our Company's Enterprise-wide Accelerate multiyear… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …its application to drug development required to deliver time, cost, quality, and risk management to teams.Demonstrated results in creating and managing complex ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager, PMO as part of the Technical Operations team based in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization ... medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network, Manages Phase 1 -… more
- Merck & Co. (Rahway, NJ)
- …Crystallization Lab Lead also plays a key role in talent management of junior engineers while driving departmental initiatives.-A high level of innovation, ... communication and collaboration skills.Good organizational, interpersonal, writing, and time management skills. Lead and operate within a cross-functional process… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and the ability to work in teams-displays initiative and commitment Engineering and risk -based management within an FDA, EMEA, GMED or TGA regulated production ... for biotechnology manufacturing. This individual is responsible for the creation, management and execution of engineering life cycle documentation and verification… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position is accountable for partnering with the Global Team leader as the Project Management lead on drug development projects. This position can be assigned to ... and functional team members.Maintains global integrated project plans, project timelines, risk management plans and communication plans. Resolves complex… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …communication, planning and management of schedule, budget, scope, issue risk management , and quality/outcomes. Communication: Ensure that assigned PMs ... program benefits in alignment with the organization's strategic objectives. Lead PgMs and PMs to manage the delivery of...track and adheres to the strategic goals. Issue and Risk management and reporting: Ensure that assigned… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …the system administrator and quality system interface for Siemens Building Management System (BMS) and Environmental Monitoring System (EMS). Relationships Reports ... to: Manager of Automation Engineering Essential Functions Lead , plan, organize and coordinate the execution of projects...users Develop and implement project(s) under the support of Sr . Engineer or external consultants as appropriate to maintain… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and recruits and develops staffing for at ... Phase 3/4 program.This position identifies and selects resources/tools to facilitate risk management during development and post-market. Additionally, this… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …compliance objectives Works collaboratively with NNI's cross-functional ethics and compliance risk management stakeholders to develop healthcare compliance ... by strategically identifying, assessing, and mitigating the organization's top risk areas. The role serves as the lead...risk mitigation efforts in alignment with the E&C's risk assessment, management and mitigation program. The… 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 ... Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …helping to develop and deliver processes, training, procurement technology and knowledge management tools. Closely partners with senior Business stakeholders to ... all Strategic Sourcing efforts through to final contract, including project management , supply analysis, supplier identification, risk mitigation, sourcing… more
- Genmab (Plainsboro, NJ)
- …Prescribing Information depending on the role for the assigned product Consult with senior management to develop and communicate regulatory strategies and advice ... 60% of the time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs, the key responsibilities include… more
- Merck & Co. (Rahway, NJ)
- …effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. Strong ... internal and external to Global Clinical Supply and serves as the lead Global Clinical Supply spokesperson at clinical and development related meetings.- Working… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …CFR part 820, 21 CFR part 4, and all associated regulatory requirements.Drive risk management in design, validation, and ongoing manufacturing. Ensure strong and ... Position SummaryThe Quality Director is the senior leader and decision maker for the Quality...and decision maker for the Quality Department and Quality Management System. This position is ultimately responsible for the… 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 ... Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics… more
