- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position This role directs and operationalizes NNI's Ethics & Compliance (E&C) risk management program by leading and managing four ... trends Collaborate with other departments to develop and implement risk mitigation strategies Lead the development and...Minimum of twelve (12) years of combined experience in risk management , ethics & compliance ,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the ability to positively influence peers, key stakeholders and management .Generates shift schedules, to ensure efficient coverage for all operational ... corrective and preventive actions, as necessary.Supports internal/external audits.Supports Quality risk assessment teams.Review/approve documents as a Quality on the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …& compliance objectives Works collaboratively with NNI's cross-functional ethics and compliance risk management stakeholders to develop healthcare ... risk areas. The role serves as the lead Ethics & Compliance Business Partner for...risk mitigation efforts in alignment with the E&C's risk assessment, management and mitigation program. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance, Medical Affairs, Translational ... Research, Informatics Services, Project Management and Operational Management . The Tech Lead must have the...architecture. Advocates for good architecture and design practices and compliance in all relevant areas. Assists IT and business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality ... the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from...and post-inspection-related activities under the supervision of the IMT Lead . Management Review: Collect the data and information… 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 ... culture in Global Regulatory Affairs and Clinical Safety for business process management and continuous improvement.-Establish and lead assigned domain Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …-based monitoring (RBM) and Central Monitoring.Responsibilities:CRA Monitoring Oversight Management :Support monitoring oversight strategy to ensure quality and ... for monitoring the following CRA central oversight activities: Determine CROs compliance with monitoring plan for on-site and remote site visits (expectations… 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
- Genmab (Plainsboro, NJ)
- …their skills and knowledge on process management & improvement, strategic & risk management planning, change management and stakeholder management . ... including GCDS Operations, GCDS Systems, Development Operations, Portfolio & Project Management , and CMC. You are skilled in professional and clear written… more
- Genmab (Plainsboro, NJ)
- …of corresponding actions and processes.Knowledge/SkillsExcellent knowledge of security and risk management frameworks and standards (eg NIST, ISO).Excellent ... will report directly to the VP and Global Head of Information Security and IT Risk & Compliance , playing a strategic role in the Information Security Leadership… 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Company and/or departmental expectations and goals as identified by senior management .Responsibilities- Acts as a brand attorney and lead legal advisor ... Marketing, Global Medical Affairs). For these areas, acts as lead attorney for that area providing legal advice and...and for review, approval, and use by Legal Affairs management . Independently negotiates contracts and other issues with third… 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
- Merck & Co. (Rahway, NJ)
- …satisfaction, driving continuous improvement in delivery efficiency and quality.Lifecycle Management and Compliance :Oversee the entire product development ... lifecycleLeadership and management skills, with proven abilities to set direction, lead and motivate team members and the proven ability to drive organizational… more
- Merck & Co. (Rahway, NJ)
- …of containment philosophies for potent compoundsExperience with Process Safety Management , Industrial Hygiene/Potent Compounds and Ergonomic Risk Assessment ... development through the implementation of the business solution using the Capital Management stage gate process with varying degrees of responsibility and will… 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
- 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 ... In this position the SMAR&D Director will set guidance, lead activities, and develop a team whose roles include...for key positions within the functional area (scientific and management pathways), including their own role.- The position is… 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 ... The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering… more
- Merck & Co. (Rahway, NJ)
- …in small molecule process characterization work by learning and utilizing Quality Risk Management (QRM) /Quality by Design (QbD) methodologies and tools ... leverages significant depth and breadth of scientific/technical experience to: (i) lead and contribute to assigned late-stage Active Pharmaceutical Ingredient (API)… more
