- Bayer (Whippany, NJ)
- …(eg, Core Data Sheet, Periodic Safety Update Report, clinical benefit- risk assessment for license renewals) for the compound(s);Lead the matrix-management ... and to interpret, discuss, and present clinical trial or section program-level data ;Proven experience with FDA regulatory requirements and ICH GCP guidelines… more
- Merck & Co. (Rahway, NJ)
- …to device systems. Strong analytical and statistical skills with experience in data interpretation and risk assessment tools. Excellent communication, ... risk management decisions and strategies.Utilize statistical methods to interpret risk data , providing clear and actionable recommendations rooted in… more
- Merck & Co. (Rahway, NJ)
- …of `quality by design` principles in assigned clinical trials.The CQOM will develop Risk Assessment and Categorization Tools and Quality Plans in partnership ... and Acquisitions (M&A), Operations Support, Pharmaceutical Management, Quality Management, Regulatory Inspections, Regulatory Submissions, Risk Assessments,… more
- Merck & Co. (Rahway, NJ)
- …exploring alternative ways to view and solve problems to achieve results Drive proactive risk management activities, including risk assessment , risk ... drug substance and drug product container closure systems including mold qualification and regulatory compliance.- To act as master data stewards and support… more
- Merck & Co. (Rahway, NJ)
- …enterprise working groups, and cross-functional projects.Ensure all innovations meet regulatory compliance, risk management, and enterprise operational ... Cyber Defense organization.Key ResponsibilitiesTechnology & Vendor EvaluationLead the technical assessment of emerging cybersecurity tools, platforms, and vendors for… more
- Merck & Co. (Rahway, NJ)
- …drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment , risk ... and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment , risk ... and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make… more
- Formation Bio (New York, NY)
- …guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment and management methodologies, with a successful track ... implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and industry best practices to support drug development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety, managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity and completeness ... for leading company response from Deal to Contract (includes pre-deal assessment /analysis, development of business cases for Pricing Committee, offer development,… more
- Formation Bio (New York, NY)
- …development plans Medical leadership in the execution of clinical trials - risk assessment , operational considerations, safety and efficacy considerations as ... for providing medical input into our Business Development product assessment strategy and execution, lead the development of the...ability to understand and navigate the complexities of healthcare data and clinical trials will be essential to your… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Non-Clinical Safety Assessment Lead will oversee non-clinical activities and safety assessments for Organon Research and ... (TMED). As part of the Non-Clinical Development (NCD) team, the Non-Clinical Safety Assessment Lead will be responsible for ensuring the fulfillment of regulatory… more
- Zoetis, Inc (Parsippany-Troy Hills, NJ)
- …Board certification in toxicology (eg, DABT, ERT) and/or DVM. Knowledge of global regulatory requirements for toxicology risk assessment and documentation to ... to support product development and registration. Hazard Communication and Chemical Regulatory Compliance (Preferred): Experience in preparing Safety Data Sheets… more
- Novartis Group Companies (East Hanover, NJ)
- …licenses (eg, Core Data Sheet, Periodic Safety Update Report, clinical benefit- risk assessment for license renewals) for the compound(s) Together with ... involving one or multiple compounds. The GPCH owns the risk benefit assessment for the program(s), and...the medical expert, leads interactions with external stakeholders (eg, regulatory authorities, key opinion leaders, data monitoring… more
- LiveRamp (New York, NY)
- … data protection laws and regulations. + Experience with due diligence and risk assessment for third-party vendors. + Privacy certifications or other similar ... and update the program to reflect changes in the regulatory landscape, emerging risks, and best practices. + Lead...privacy laws, regulations, and industry best practices affecting third-party data usage. + Be accountable for risk … more
- SMBC (Jersey City, NJ)
- …set in model validation and model development; and working with large and complex data sets. + Ability to apply regulatory requirements outlined in CECL, IFRS9, ... employees. **JOB SUMMARY:** Reporting to the Head of Model Risk , the Risk Model Validation Director plays...ongoing monitoring. + Conducts thorough review on model annual assessment , model changes, and ongoing monitoring results. + Develops… more
- HSBC (New York, NY)
- …and internal controls are in place, including processes for management of operational risk , in accordance with Company and regulatory standards + Identify audit ... corporate lending, specialized lending, global trade finance and global payment solutions, Credit Risk , Regulatory Compliance, Internal Audit etc) + Minimum of a… more
- SMBC (New York, NY)
- …providing foundational data and analytics that enable accurate pricing, risk assessment , and trade decision-making across global markets. **Role Objectives** ... for pre-trade analytics platforms, ensuring alignment with trading, risk , and regulatory objectives. + Prioritize features that enhance data quality, speed… more
- SMBC (New York, NY)
- …initiatives related to climate risk integration, ESG-related credit exposure assessment - Integrate regulatory expectations (eg, SR 15-18, SR 12-7) ... Lead end-to-end stress testing analytics for wholesale credit portfolios, including risk identification, scenario design, loss forecasting, data preparation,… more
- FHI 360 (New York, NY)
- …change, and commitment to improvement and innovation. Supports the legal, management, and risk assessment work. Ensures proper filing of relevant legal records. ... status and fundraising; contracts and commercial transactions; patent, trademark, and copyright; data privacy; and risk management. The Associate General Counsel… more
- HSBC (New York, NY)
- …development, federated operation through to the protocol demise. Drive a data -centric approach to observability and assessment , wherever possible supported ... by automation, measures and analytics + Ensure regulatory and risk management outcomes are being maintained or robustly managed. Ownership of High- Risk … more
