- 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
- Merck & Co. (Rahway, NJ)
- …lives. - As the Company's portfolio continues to evolve and expand, the Associate Director , External Manufacturing, Global Vaccines Operations (ExM GVO) Finance ... Operations team, which includes senior and operational leaders, the Associate Director will provide financial analyses and...making across vendor selection, contract negotiation & review and risk assessments and will be the primary point of… more
- Merck & Co. (Rahway, NJ)
- …to a Technology Director in Global Engineering Solutions (GES), the Associate Director will be part of a high performing team, accountable ... growing portfolio of Large Molecule, Small Molecule, and Animal Health work.The Associate Director participates in project activities ranging from business case… more
- Merck & Co. (North Wales, PA)
- …development, personal growth and overall effective support by the Operations Team.- The Associate Director position will report to the Executive Director , ... Job DescriptionAssociate Director , Ethics and Compliance Office (ECO) Operations The...and support COI tool enhancementsSupport efforts to standardize ECO's risk assessment and mitigation processesSupport efforts to assess compliance… more
- Merck & Co. (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... promotional concepts that meet business objectives and minimize regulatory risk -Provide regulatory consultation in the development and implementation of US… more
- Merck & Co. (Rahway, NJ)
- …and 10 years overall within biopharmaceuticals. Planning and facilitating high risk and highly complex Quality-related process reviews and/or investigations under ... minimal supervision. Providing project leadership in area of expertise in own discipline (such as leading or facilitating teams involving source area representatives in a matrix management environment). Identifying trends and/or potential compliance gaps and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:Reporting to a Technology Director or Associate Director in Global Engineering Solutions (GES), the Associate ... growing portfolio of Large Molecule, Small Molecule, and Animal Health work.The Associate Director participates in project activities ranging from business case… 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 ... 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
- Merck & Co. (North Wales, PA)
- …a key member of the US Oncology Omni-Channel Strategy & Innovation team, the- Associate Director , US Oncology Marketing - Customer Engagement Strategy & ... detail-oriented approachInnovative mindset with affinity toward experimentation and appropriate risk takingExcellence in change management and demonstrated ability to… 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)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical and ... design, engineering analysis and testing, medical device design controls, risk management, test method/fixture development, design verification and validation,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions Provide strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …impactful risk mitigation strategies. Relationships Reports to the Senior Director , E&C Business Partner. Coordinates with employees in the Ethics & Compliance ... by strategically identifying, assessing, and mitigating the organization's top risk areas. The role serves as the lead Ethics...customer groups. The role is pivotal in driving strategic risk mitigation efforts in alignment with the E&C's … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... and other key internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing relationships with internal… 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. (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 ... 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)
- …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. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... compliance mindset and collaboration with various partners and stakeholders in development.The Director will report to the Executive Director of Biologics and… 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
