- 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: Policies & ... This leader plays a critical part in designing and driving the core risk management operations of the E&C team, ensuring the identification, assessment, and… more
- Fidelity Investments (Boston, MA)
- …Description:The RoleThe individual will be a member of the dynamic and energetic risk team within Fidelity's Legal, Risk , and Compliance (LRC) organization ... individual will be charged with working across the team to provide valuable risk management insight to our business partners, including performing risk … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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 ... plans across functional teamsDefines the interdependent deliverables and ensures that quality, risk , cost, time are managed within the overall approved plan to drive… more
- Fidelity Investments (Boston, MA)
- Job Description:The TeamAsset Management Risk provides direction to management and business units by proactively identifying and monitoring risks to protect the ... the firm, clients, and associates. To execute this goal, Asset Management Risk is responsible for identifying, analyzing, aggregating, and reporting on significant… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ine management responsibility of Director/Associate Director Global Safety Lead, Senior Global Safety Scientist(s)/Global Safety Scientist(s) within the Safety ... Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as required by… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval ... and other applicable worldwide regulations and our Company procedures.- The Senior Specialist will become knowledgeable in regulatory requirements, cGMPs and our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery… more
- Merck & Co. (Rahway, NJ)
- …RaDS IT Research Infrastructure Product Line (RIPL) engineering team is seeking a Senior Specialist - Research Automation OT Infrastructure. This position will be a ... and global functions such as infrastructure, engineering, system security, risk management, etc.Education Requirement:-Bachelor's degree in automation, engineering, computer… 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 ... of product licenses (eg, Core Data Sheet generation/revision; clinical benefit- risk assessments for license renewals, responses to Health Authority)Participant and… more
- Genmab (Plainsboro, NJ)
- …an innovative and growing organization? At Genmab, we're seeking a Senior Director, Strategic Planning & Effectiveness to drive cross-functional communication, ... cross-functional and global franchise leadership meetings, escalating critical issues to senior leadership.Collaborate with the SVP to manage US Oncology Leadership… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Senior CQV Specialist as part of the Commissioning and Qualification team based in ... review of change controls, SOPs, and other documentationParticipates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and… more
- Fidelity Investments (Boston, MA)
- Job Description: Senior Manager - Global Financial Controls Center of ExcellenceThe Global Financial Controls Center of Excellence (GFC-CoE) is an enterprise-wide ... also provides advisory services for select strategic initiatives and modernization efforts.The Senior Manager role will deliver significant value to the business by… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for synergies between the products. When goals are tactically misaligned or at risk for these assets, this leader will be responsible for bringing the issue ... and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist on the assets. This role will be accountable for ensuring consistent and transparent ways of working across the Alliance within US regulatory affairs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a proactive approach to ethics and compliance, focusing on partnership, risk mitigation, prevention, and the advancement of business development areas, including ... processes surrounding emerging therapeutic areas Supports E&C teams with special projects, as needed Physical Requirements 10-20% overnight travel required. Qualifications A Bachelor 's degree from an accredited institution required, additional… more
- Novo Nordisk Inc. (Durham, NC)
- …Operate within compliance with a Quality Mindset that focuses on risk management & mitigation Implement effective Change Management Support Corporate, OFP, ... local IT & local stakeholder initiatives & projects Govern behavior based on the Novo Nordisk Way Other accountabilities as assigned #IND23 Physical Requirements Ability to work in an open office environment with the possibility of frequent distraction.… more
- Fidelity Investments (Boston, MA)
- …us with the deep expertise necessary to build the future of finance. As a Senior Manager - Product Delivery Analysis on the FDA Product Delivery team you would have ... closely with team members in operations, client service, business development, risk , compliance, legal and technology areas.This role requires a dedicated, curious,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary: This position is responsible for implementation and oversight of the Risk Based Quality Management (RBQM) principles that support the Company's vision ... elements to achieve a Quality by Design (QbD) and Risk -Based Quality Management (RBQM) approach to clinical trial conduct....activities for Daiichi Sankyo Portfolio of Studies: Serve as senior level technical RBQM SME and oversee and mentor… more
- Twist BioScience (South San Francisco, CA)
- …Director of Internal Controls and Financial SOX Compliance is a senior -level position responsible, which oversees Twist's Sarbanes-Oxley (SOX) compliance program, ... and tracking SOX remediation initiatives, and communicating compliance status to senior management and external auditors. This role will collaborate closely with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and recruits and develops staffing for at least ... 3/4 program.This position identifies and selects resources/tools to facilitate risk management during development and post-market. Additionally, this position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and execution of ... Strategy:Align with the Head of Clinical Development Operations or Senior Director, Clinical Operations on plans for successful implementation of… more
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