- Sandoz Group AG (Princeton, NJ)
- …products and therapeutic areas. You will be responsible for overseeing P&L management , sales, marketing, and generics portfolio strategy to maximize product ... products and therapeutic areas. You will be responsible for overseeing P&L management , sales, marketing, and generics portfolio strategy to maximize product… more
- Integra LifeSciences (Princeton, NJ)
- …responsible for overseeing the Information System's contract lifecycle and software asset management strategy . This role ensures compliance with best practices, ... legal and regulatory requirements, optimizes software licensing, and manages vendor relationships...new system onboarding, and decommissioning processes. + Financial & Risk Management : + Monitor software spend and… more
- Parexel (Trenton, NJ)
- …and follow up of regulatory inspections. **Primary Duties:** Operational Quality Management : + Develop Risk Assessment and Categorization Tools (RACT) and ... Experience with delivering effective CAPA management solutions. + Experience with risk management tools and processes within the clinical quality framework.… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …and procedures to be documented and set up. Establish the pharmacovigilance Quality Management System and achieve compliance with US regulatory requirements + ... areas. Review existing products for safety risks and generate report on product risk -benefit ratio and develop proposal for regulatory agencies and manage the… more
- Integra LifeSciences (Princeton, NJ)
- …and industry trends to improve performance in key focus areas such as Risk Management , Product Usability, Change and Design Controls. Provide guidance to ... of existing products for consideration in new product development. + Review for approval Risk Management Documentation including but not limited to Risk … more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …+ Develop scenario planning and sensitivity analysis to support investment decisions and risk management . + Work closely with Commercial leaders, Market Access, ... Insights will play a pivotal and highly visible role in shaping commercial strategy . This will be achieved through deep market understanding, transforming data and… more
- BeOne Medicines (Pennington, NJ)
- …technology transfer, validation, continued process verification, investigations, change management and manufacturing startup. Reporting to the MST leadership, ... and process lead for drug product, ensuring the materials, strategy and documentation are in place. + Collaborate with...throughout the lifecycle of a program and maintain process risk assessment documents. + Author PPQ protocols and reports.… more
- Parexel (Trenton, NJ)
- …does not include any direct medical advice on patient care or management + Communicate with relevant sponsor counterparts on challenges and accomplishments related ... actions contributing to the success of the study/project and risk mitigation + Creating a sense of urgency on...including medical review of serious adverse events. - Support regulatory safety reporting activities - Ensure client needs and… more
- Integra LifeSciences (Princeton, NJ)
- …and reliability. You will play a critical role in our supply chain management strategy , collaborating closely with cross-functional teams to support our mission ... and cost savings. Resolving any issues or disputes with suppliers efficiently + Risk Management : Identify potential risks within the supply chain + Market… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project management , change management , and risk management . Responsibilities Leadership, Direction, and Strategy : - In collaboration with Clinical ... Management globally and ensures execution of the data management strategy across regions. This individual is...that Data Management Plans are consistent and regulatory compliant across studies and programs.- Promotes Risk… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …with regulatory agencies (FDA, EMA, etc.); support or lead preparation of regulatory submissions (eg, pre-IND, IND, BLA).Contribute to risk assessment of new ... .Collaborate closely with internal functions such as Pharmacology, CMC, Regulatory Affairs, Clinical, and Program Management .Maintain up-to-date knowledge… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …signal, epidemiological data, and regulatory requirement synthesize into a coherent risk management strategy .Represents the CSPV department as subject ... assures the quality of the material content of any documents sent to regulatory authorities. Provides compliance metrics to management , as needed.Lead continuous… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …access programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design, ... status, escalating issues in a timely manner for earliest resolution, Regulatory Inspections:Facilitates regulatory inspection preparation, management , and… more
- Formation Bio (New York, NY)
- …Quality Assurance are to develop and implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and industry best ... requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …identified during internal systems audits, remediations implemented and CAPAs pending.Support Risk Mitigation programs to ensure compliance to regulatory ... processes of the Daiichi Sankyo's GxP group.Together with regional management teams plans, will support, conducts and reports internal...in alignment with the Master Audit Schedule using a risk -based approach to ensure the Audit Plans are aligned… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to drug product manufacturing required to deliver time, cost, quality, and risk management to teams.Experience with Healthy Authority requirements and ... implementation in cGMP production environment. The individual will be responsible for management and delivery of the integrated project and program plans, ensuring… more
- Merck & Co. (North Wales, PA)
- …stakeholders and train technical teams.Familiar with change control, deviation management , protocol/report authorship, and regulatory license documentation. ... and practical commercial manufacturing judgment. You will lead technical strategy , science-based technology transfer and scale-up of freeze-drying and fill-finish… more
- Merck & Co. (Lower Gwynedd, PA)
- …Engineering, Packaging Equipment, Packaging Processes, Pharmaceutical Packaging, Process Optimization, Regulatory Requirements, Risk Management , Root Cause ... tasks.Extensive experience with quantitative decision tools for root cause analysis, risk management and options analysis.Exhibited leadership qualities such as… more
- Merck & Co. (Upper Gwynedd, PA)
- …participants with hands-on exposure to finance, accounting, auditing, analytics, risk management , and special projects.Throughout the program, individuals ... Management Controls, Microsoft Excel, Preparation of Financial Reports, Procurement, Reputational Risk , Stakeholder Management , Treasury Management {+ 1… more
- HSBC (New York, NY)
- …high expectations and is likely to come under scrutiny as part of any major regulatory investigation. Management of Risk + Ensure all actions take account ... Regulatory Compliance Brand: HSBC Area of Interest: Risk and Compliance Location: New York, NY, US, 10001...framework. The Director of Wealth, Private Banking and Insurance Regulatory Compliance for US is the management … more
