- Formation Bio (New York, NY)
- …Strategic Thinking & Problem Solving Propose solutions to common program challenges, including resource constraints and risk mitigation ... activities and making informed trade-off decisions. Facilitate contingency planning and risk mitigation strategies to ensure program continuity. Operational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GxP group and its partners as applicable ensuring the execution of a risk -based audit program and effective CAPA management resulting from audits, health ... Manager Audits & Compliance, GCP/Document Audits supports end-to-end audit activities per audit program of GxP relevant audit activities for the Daiichi Sankyo's… more
- Merck & Co. (Rahway, NJ)
- …will lead a team of approximately 3-5 scientists, who lead multidisciplinary program teams and drive innovation in biologics DS manufacturing and commercialization ... documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance… more
- Merck & Co. (Rahway, NJ)
- …experts within the broader DD&T team (eg design verification, device risk management, human factors, technical integration, assembly automation, etc.), as well ... manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence clinical and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as appropriate for the area of GxP audits assigned.Responsibilities:Execute the audit program for internal systems as applicable for the area of GxP audits ... assigned in alignment with the Master Audit Schedule using a risk -based approach to ensure the Audit Plans are aligned with the company's strategy and objectives and… 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 will also ... drawingsProcess development and technology transfer experience including the use of risk assessment and process capability (Ppk) tools.Candidate should have solid… more
- Merck & Co. (Rahway, NJ)
- … risk management activities.Lead the preparation of materials for program presentations for management review and regulatory submission.Contribute to the ... experienceHas broad knowledge of medical device development, design controls and risk managementLed and managed development of DHF (design history file) deliverables… more
- Merck & Co. (San Francisco, CA)
- …and data-driven decision-making. Under the broad guidance of the DSCS Digital Program Mgmt Lead, the Associate Director, DSCS Digital Project Manager, will be ... sub-team and use-case leads to track use-case metrics and rollup into program KPIs. Implement and manage any associated measurement methodologies (surveys, forms,… more
- Merck & Co. (Rahway, NJ)
- …candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This ... following current Good Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDPs).-… more
- Merck & Co. (Durham, NC)
- …in our EHS organization available which is accountable for all EHS program execution and compliance at our Manufacturing Division's vaccine manufacturing facility in ... complying with one or more regulatory programs: RCRA and High- Risk Work (eg elevated work, confined space, hot work,...& build a strong teamProven experience leading a site program such as Manufacturing, Research, Tech Ops function, Quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …enterprise technologies and will also be responsible for performing technical risk and vulnerability assessments at the network, system, and application level. ... responsibilities developing and implementing security controls and formulating operational risk mitigations. Relationships: Reports directly to the manager of Global… more
- Novo Nordisk Inc. (Denver, CO)
- …a strong command and understanding of all Legal, Privacy, and Compliance risk associated with community engagement Ensures all activities are executed in close ... disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program ; tuition reimbursement program ; and voluntary benefits such as… more
- Novo Nordisk Inc. (Olathe, KS)
- …overall strategy, demonstrating an openness to coaching and executing educational program goals within the territory Clinical Addendum - Obesity Establish Obesity ... Standards of Care for diabetes, including management of CV risk in patients with type 2 diabetes, to educate...Care for cardiovascular disease, highlighting the management of cardiovascular risk in patients with type 2 diabetes and obesity,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the Head of Functional Excellence, across key functions to improve the benefit- risk in patients treated within the oncology compounds throughout the course of ... of Clinical Development processes. Job Description:Execute an overarching safety program tailored for AEs from end-to-end: understanding predisposing non-clinical… more
- Merck & Co. (Rahway, NJ)
- …Identify and design improvement opportunities within the Support Model to reduce compliance risk and increase efficiency for the Support Team and End Users. Conduct ... Specific Global User Group Forums, Release/System Communication authoring and Program Updates, as requested.Preferred Experience and Skills:Candidate must be… more
- Merck & Co. (Rahway, NJ)
- …desired results. Reviews and defends stage-gate deliverables for programs including risk assessment and mitigation plans and engages in corporate governance meetings ... Common Technical Document (eCTD), Ethical Compliance, Global Health, Global Program Development, High Performance Team Building, Human Resource Management,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Provides technical expertise in support of an effective calibration program that supports daily clinical production and strategically prepares for ... Out of Tolerance (OOT) situations and other technical documentationConducts basic risk mitigation options and advanced troubleshooting to identify root cause and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in support of company objectives, operating model decision, mitigate decision risk , drive action plan development and ultimately improve commercial and clinical ... disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program ; tuition reimbursement program ; and voluntary benefits such as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and propel data-driven decision-making.Promotes a culture of creativity and risk -taking, alongside developing processes that encourage experimentation and innovative ... disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program ; tuition reimbursement program ; and voluntary benefits such as… more
- Citigroup (Getzville, NY)
- …thought leadership on fulfilling regulatory obligations. Senior Project Managers in the Risk Program Management organization are expected to have excellent ... against commitments, dependencies, and resource needs. + Leverage knowledge of Credit Risk Management to perform end-to-end review-challenge of program scope and… more
