- Genmab (Plainsboro, NJ)
- …policies; and (ii) the implementation and oversight of Genmab's third-party privacy risk compliance function. Successful candidates will have a deep ... the implementation of technical rules and standards for privacy compliance in data life cycles and deployment of technologies...oversight of Genmab data processors in accordance with Genmab's risk management framework and data privacy and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …completed in compliance and meets Novo Nordisk's business standards Risk Management : Assessing and mitigating risks associated with operations, implementing ... to make a difference? The Position Drive portfolio strategy and study management activities and manage cross-functional study team, external service providers (CROs,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …new ideas, solutions, methods or opportunities; foster innovation through appropriate risk -taking and experimentation to ensure that the Medical Promotional Review ... product labeling committees and other department projects/initiatives Demonstrates the people management skills needed to lead direct reports and working teams;… more
- Genmab (Plainsboro, NJ)
- …Profile). For approved products, ensure that regulatory strategies throughout life-cycle management are in place and implemented including label improvement, health ... This responsibility will involve collaboration with a partner. Evaluate regulatory risk and recommend mitigation strategies to ensure optimal regulatory success.… more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) of ... New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports,… more
- Tris Pharma (Monmouth Junction, NJ)
- …Leadership team including insights on financial performance, capital allocation, and risk management ; Directs cost monitoring and reporting activities; Drives ... In depth knowledge of corporate financial law, compliant financial reporting and risk management practices Excellent knowledge of data analysis and forecasting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards ... in fast-paced environment, continuous improvement, project management , change management , and risk management .Responsibilities:Leadership, Direction, and… more
- Formation Bio (New York, NY)
- …health authority audits.Responsibilities Develop, implement, and maintain the pharmaceutical quality management system (QMS) to ensure compliance with regulatory ... and implement corrective and preventive actions (CAPAs) effectively. Proficiency in quality management tools and methodologies (eg, risk assessment, root cause… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …globally and with external parties as required.Champions 'Quality by Design' and Quality Risk Management approaches to quality management within Daiichi ... other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and...sites.Introduce and implement methods to detect fraud or site non- compliance such as: different approaches to data review in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …reports, interpret results, and generate technical conclusions consistent with quality risk management principles.Recognize patterns and trends in reported data ... sample materials.Perform spot-checks in the QC Laboratories to ensure compliance with written regulations, policies, procedures, and global procedures.Strive...and communicate to management .Require minimal direction to complete tasks, knows how to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to ensure processes are robust and continuously improving. Work with the Data Management and Integration Lead and Process Validation lead on the establishment and ... management of a process monitoring program. Establish metrics for...manufacturing operations.Support writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processesAbility to work… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Operations on the DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place for all ... ensure compliance with Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification and Management Log (RIM Log) and other risk … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relations, internal communications, public disclosures, social media policies, compliance , crisis communications, and diversity initiatives. Develops contract ... within DSI and global entities, advising on legislative and regulatory compliance , lobbying activities, political contributions, public policy development, and state… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to identify QA risks at CMO's and support the recommended courses of risk treatment and resolution manner in appropriate way and to ensure continuous improvement ... in the management of CMO risks. Interacts with DS affiliates to...approval of documents associated with validation or qualification activities, risk assessment strategies, technical studies and applicable changes that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …best practices of data security, role & security model design, hierarchical security, compliance and CAPA response & management ; knowledge of industry standard ... Administration is a member of the Biostatistics and Data Management Data Operations team and serves both as a...of identified access discrepancies per study to maintain overall compliance and inspection readiness of the application. This position… more
- Merck & Co. (North Wales, PA)
- …limited to global orchestration lead, manufacturing, supply chain, IT, legal/ compliance , market access, marketing, precision medicine, and field commercial. Provide ... experience in the end-to-end patient journey.- Develop and implement risk -mitigation strategies and enhancement features to support optimal customer experience… more
- Formation Bio (New York, NY)
- …change management , and vendor oversight. The Sr. Director ensures compliance with cGMP standards, oversees QA activities at CDMOs, performs critical ... and implement corrective and preventive actions (CAPA effectively. Proficiency in quality management tools and methodologies (eg, risk assessment, root cause… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally ... role of both operational strategy and study execution. Responsibilities:Study Management & Leadership:Has primary accountability for operational study level time,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Company and/or departmental expectations and goals as identified by senior management .ResponsibilitiesActs as a brand attorney and lead legal advisor for the ... both independently and for review, approval, and use by Legal Affairs management . Independently negotiates contracts and other issues with third parties (vendors,… more
- JPMorgan Chase (New York, NY)
- …outside the box, challenging the status quo and striving to be best-in-class. As a Compliance Risk Management Lead Vice President covering the Futures and ... Bring your expertise to JPMorgan Chase. As part of Risk Management and Compliance , you are at the center of keeping JPMorgan Chase strong and resilient. You… more
