- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Principal Scientist, Device Risk Management Lead, is a crucial member of our team, responsible for spearheading risk management ... through launch and post-market surveillance. Key Responsibilities and Activities: The Associate Principal Scientist, Device System - Device Risk Management… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to make a difference? The Position We are looking to hire an Associate Director of Clinical Operations. This is a unique opportunity to work in a growing ... Operations Department that manages multiple early to late-stage clinical programs. The Associate Director role will be responsible for all aspects of clinical trial… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Technical Lead as part of the Technical Operations team based in ... Raritan, NJ. Role OverviewThe Associate Technical Lead will be part of Technical Operations...manufacturing operations.Support writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processesAbility to work… more
- Merck & Co. (Rahway, NJ)
- …Director of Medical Device and Combination Product Quality Assurance, the Associate Director Quality Engineering & Quality Assurance is responsible for independent ... and Combination Product current Good Manufacturing ruling (21CFR part 4), Device Risk Management (ISO 14971) and other worldwide regulations and requirements. This… more
- Merck & Co. (Rahway, NJ)
- …DescriptionReporting to a Technology Director in Global Engineering Solutions (GES), the Associate Director will be part of a high performing team, accountable for ... portfolio of Large Molecule, Small Molecule, and Animal Health work.The Associate Director participates in project activities ranging from business case development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to maximize your potential with us? The Position As the Associate Director of Strategic Market Insights, the functional responsibilities include leading ... proactively address issues in support of business objectives, mitigate decision risk , drive action plan development and ultimately improve commercial planning… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as required by ... deliverables Is responsible for Safety Input to all activities for Risk Based Monitoring across the development project Physical Requirements Approximately 10%… more
- Merck & Co. (North Wales, PA)
- …the Director/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
- 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
- Merck & Co. (Rahway, NJ)
- …Middleware team (Informatica, TIBCO) for data mapping.Manage and design IT risk assessments, including identifying, evaluating, and analyzing risk ... mitigation.Education:Bachelor's degree in computer science, Information Systems, or related field.Required Experience and Skills: Minimum 7 years of experience consisting of Product and Program Management, Payroll Business and Technical Analyst, with strong… 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. (Los Angeles, CA)
- …trials, in line with established targets and strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites, ... leveraging Risk Based Quality Management (RBQM) principles and tools; executes activities relevant to all visit types (Site Selection, Site Initiation, Monitoring,… 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
- 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
- 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
- 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
- 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
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