- Legend Biotech USA, Inc. (Raritan, NJ)
- …and implement modifications to risk assessment plans.Key Responsibilities Follow QRM (Quality Risk Management ) process per ICH Q9, identify the risk , ... Risk Assessment Specialist as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position...well as problems and solutions, and implement and manage change when necessary to meet risk assessment… more
- Merck & Co. (Rahway, NJ)
- …Units (OpUs) as it relates to in-line product management , supplier management , risk management and savings identification.Works closely with DMLT ... while remaining a financial steward.Scope:-Responsible for all in-line product execution, risk management and escalation.-Emphasis on matrix management … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …opportunities, track key performance indicators, and assess the efficiency of legal operations Collaborates and drives spend management , analyses and reporting ... Nordisk, your skills, dedication and ambition will help us change lives for the better. In exchange, we'll offer...A minimum of 8 years of expereince in legal operations , financial analysis, and/or project management within… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related to policy, processes, technology, tools, and other process matters. Leads organization change management for changes in policy, process, platform Issue ... organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence… more
- Merck & Co. (Durham, NC)
- …and outstanding problem solving skillsSustaining the validated state through change management and continuing validation studiesExperience with validation ... with cross-functional teams (ie Maintenance, Global Engineering, Quality, and Operations } to ensure a successful technology transfer, filing, and licensure… more
- Merck & Co. (North Wales, PA)
- …business need, identify opportunities, and implement and measure solutions Program & Change Management Roadmap Implementation Management : Partner with ... tools Improve engagement and adoption of omnichannel programs through scaling, change management , and training activities Evolves, promotes, and grows the… more
- Genmab (Plainsboro, NJ)
- …of corresponding actions and processes.Knowledge/SkillsExcellent knowledge of security and risk management frameworks and standards (eg NIST, ISO).Excellent ... futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment… more
- Merck & Co. (Durham, NC)
- …experience related to plant maintenance and spare parts procurement systemsProject management , including change control and equipment qualification WORKING ... with key clients and/or customers to support business needs PEOPLE MANAGEMENT Leads Engineering & Maintenance team organization, including associate directors,… more
- Genmab (Plainsboro, NJ)
- …track record of applying data quality methodologies to enhance business operations , risk management , and decision-making processes.Strong leadership ... degree a plus12+ years of professional experience in data management / operations experience preferably within oncology/hematology, and/or management5+ years… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …skills in designing and implementing innovation/improvement initiatives, including the required change management We commit to an inclusive recruitment process ... degree; Advanced degree preferred Minimum 10 years of experience with Supplier Management , Research Administration, Grant Operations , Grant Management ,… 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 ... critical thinking to advance biopharmaceutics strategy across the portfolioProject management skillsAttention to technical detailBuilds collaborations across internal departments… more
- Novo Nordisk Inc. (Boulder, CO)
- …the Department The Boulder Site is home to the specialized technical operations /CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the ... process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado… more
- Aequor (Thousand Oaks, CA)
- …and best practices ; strong analytical skills ; business process development best practices, change management ; strong MS Project, MS Word, MS PowerPoint and MS ... agile practices to enhance team performance and continuous alignment to Operations prioritized agenda. You will work closely with product owner, development… more
- Merck & Co. (Durham, NC)
- …system(s) remain in a validated status (eg, problem and incident management , change control, periodic review, investigations, backup/restore, System Use ... integrity. Work closely with stakeholders and SME's from site operations , quality operations , IT, automation and engineering...initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work. Provide… more
- Merck & Co. (North Wales, PA)
- …regulatory filing expenses.Further develop creative thinking and problem-solving skills.Gain experience in change management , project management and people ... personal network through engagement with other key business partners (IT, Project Management , Human Resources, Procurement, etc.) Travel: Limited to no travel in the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as ... Hub. Key internal stakeholders include Medical & Science, Clinical Operations , Regulatory Affairs, Data Management , Biostatistics, Non-clinical, Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Validation Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports.Support the change management process for validated systems where necessary.Maintain ... timelines and resource requirements for CSV projects. Work within a risk -based framework (Computer Software Assurance (CSA)) that is compliant with global… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … change controls, SOPs, and other documentationParticipates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual ... myeloma.Legend Biotech is seeking CQV Specialist I as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible for… more
- Aequor (Thousand Oaks, CA)
- …and close-out. Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to ... AM to 5:00 PM schedule, with occasional early meetings to support global operations . Ideal candidate: This role requires a technically skilled professional with at… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Financial Disbursements, that manages the day-to-day Financial Disbursement operations (Accounts Payable Processing, Travel and Expense Reimbursement and ... and accuracy of payments. Specifically, this role will be accountable for operations , suggest and collaborate with Financial Disbursement team members and global… more
