- Merck & Co. (Rahway, NJ)
- …Knowledge of IAM, Network Security, Endpoint Security, Security Operations, Risk and complianceStrong Grasp of Architectural Principles and Technologies: Deep ... familiarity with modern architectural methodologies including serverless architectures, microservices, and the principles of DevSecOps. Ability to leverage these technologies to deliver innovative and effective security solutions that align with business… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director, Global Regulatory Affairs, Regulatory Strategy to be a part of ... BLA submissions, tracking of progress of PMRs and PMCs, etc. Evaluate regulatory risk and recommend mitigation strategies to global regulatory lead to ensure optimal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(E&C) program by strategically identifying, assessing, and mitigating the organization's top risk areas. The role serves as the lead Ethics & Compliance Business ... customer groups. The role is pivotal in driving strategic risk mitigation efforts in alignment with the E&C's ...risk mitigation efforts in alignment with the E&C's risk assessment, management and mitigation program. The Business Partner… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:Reporting to a Technology Director or Associate Director in Global Engineering Solutions (GES), the Associate Director will ... portfolio of Large Molecule, Small Molecule, and Animal Health work.The Associate Director participates in project activities ranging from business case development… more
- Merck & Co. (Rahway, NJ)
- …understanding and to support project timelines.Development experience in risk -oriented, regulated environmentsDevelopment project leadership with a proven track ... (21 CFR 820.30)Familiarity with the following standards: Quality Management - ISO 13485, Risk Management - ISO 14971, EU MDR, ISO 11608 Needle-based injection system… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory ... disease states based on current regulatory environment and competitive landscape Assess risk and advise on mitigation strategies to meet overall business need, while… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …HR operations within the organization. By exercising financial prudence, identifying risk areas, and maintaining transparent reporting, the role supports the ... review with POLT/POLT -1 for monthly review and quarterly POLT Ops Identify risk areas and contribute to the development of remediation efforts for key investments… more
- Merck & Co. (Rahway, NJ)
- …the following: process characterization (PC), process performance qualification (PPQ), risk assessment (RA), control strategy, process comparability reports, and/or ... regulatory submissions (BLA/MAA/JNDA etc.).Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment.Experience and aptitude to lead, work, and collaborate in internal and external… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... key internal stakeholders. In the execution of specific projects, the Associate Director, will be accountable for managing relationships with internal stakeholders… more
- Merck & Co. (North Wales, PA)
- …problem-solving and decision-making skills, with a proactive approach to risk management and issue resolution.Solid organizational and time management skills ... to prioritize tasks effectively.Knowledge of procurement sourcing processes, particularly in contract manufacturing organization (CMO) sourcing activities.Proven experience in developing and implementing PMO policies and procedures.Ability to provide training… more
- Merck & Co. (Rahway, NJ)
- …Prepare Quarterly IQV (Inventory of Questionable value) analysis to identify inventory at risk and present results to Senior Management. Perform a review of our ... Company's top key products in order to understand inventory trends. Meet with inventory planners from Supply Chain Management to identify matters affecting inventory levels Review inventory footnote and work with consolidation/accounting standards to ensure… more
- Merck & Co. (Rahway, NJ)
- …needed Demonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence portfolio ... decisions with facts and data Demonstrates ability to balance strategy with ability for tactical execution and has strong ownership & accountability of assigned work - Drive continuous improvement initiatives to enhance the efficiency, accuracy, and… more
- Merck & Co. (Lower Gwynedd, PA)
- …The Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late Development ... coaching.Work closely with divisional/enterprise IT teams, global infrastructure, and risk /security organizations to ensure that project deliverables and ongoing… 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 to meet ... smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical issues, or to the governance… more
- Merck & Co. (North Wales, PA)
- …and preparing for multiple potential launches of our medicines and vaccines. As the Associate Director of Launch Strategy and Operations, you will play a vital role ... and cross-functional interdependencies across all launch workstreams.Lead scenario planning, risk assessments, and prioritization of critical launch activities.Create comprehensive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management, Quality Assurance, Medical Affairs, Translational Research, ... Research, Informatics Services, Project Management and Operational Management. The Tech Lead must have the ability to develop a strong, positive strategic business partnership with the global business and Global IT functions at Daiichi Sankyo. As a trusted… more
- Genmab (Plainsboro, NJ)
- …the CV of PL/PMRisk ManagementIdentify study risks with the CTT and oversee risk management activitiesMaintain and oversee the CTT issue log and ensure timely issue ... resolutionEnsure CTT action and decision logs are up-to-dateSupport audit preparation and responsesImplement Corrective and Preventive Actions (CAPAs), if applicableRequirementsBachelor's or Master's degree with relevant specialization; Master's degree… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …final contract, including project management, supply analysis, supplier identification, risk mitigation, sourcing execution, high level negotiations, award of ... business etc), with senior business stakeholders. Consult senior Business stakeholders with procurement insights and guidance to influence and help inform business decisions and drive optimal value. Possesses a large range of diverse knowledge of… more
- New York life (Uniondale, NY)
- …before you can offer investment products. Phase 2: Your transition to Associate Partner After meeting specific requirements during the first 12 months as ... a financial professional, you will enter a specialized six-month Associate Partner training program.1 We'll help you to lead...any investment products as they are subject to market risk and will fluctuate in value. 7 A full… more
- Merck & Co. (Rahway, NJ)
- …have 10-15 direct reports composed of experienced, senior and associate scientists.- The successful candidate will effectively partner with Biologics ... policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also… more
