- Merck & Co. (Rahway, NJ)
- …for our patients, partners, and colleagues.As a Technical Product Manager for the Compliance, Risk , Quality, & Vendor Management product you will spend a lot of ... background to help us shape the vision and strategy of our software products in the clinical domain.The...organization. Candidate will be accountable for the entire Compliance, Risk , Quality, & Vendor Management product from… more
- Merck & Co. (Rahway, NJ)
- …implementation of procurement strategy , Global Category Management , contract management , risk management , stakeholder management , and supplier ... of spend, resulting in breakthrough strategies which optimize value and ensure appropriate risk management . Understands the Sourcing Management Process and… more
- Merck & Co. (Rahway, NJ)
- …Pharmaceutical Packaging, Risk Communications, Risk Evaluation And Mitigation Strategy (REMS), Risk Management {+ 5 more}Preferred Skills: Current ... drug product container closure systems including mold qualification and regulatory compliance.- To act as master data stewards and...view and solve problems to achieve results Drive proactive risk management activities, including risk … more
- Merck & Co. (Rahway, NJ)
- …product development, such as manufacturing process development and validation, design control, risk management , material and molding, design validation to create ... with design verification, including but not limited to, design controls, risk management , materials & molding, process development and validation,… more
- Merck & Co. (Rahway, NJ)
- …and inspire accountability Ethical, resilient, and committed to excellence Skilled in risk management , team facilitation, and strategic planning Experience in ... guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external manufacturing… more
- Merck & Co. (Rahway, NJ)
- …Logistics, Multiple Therapeutic Areas, Process Optimization, Publications Management , Regulatory Compliance, Risk Management , Sourcing and Procurement, ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines, strategies and… more
- Merck & Co. (Rahway, NJ)
- …not limited to: Work closely with the group Director to shape and execute strategy for biological characterization in all stages of clinical development, as well as ... using quality by design principles and with focus on comprehensive life-cycle management . Mentor and supervise junior colleagues; coach, and develop talent within… more
- Merck & Co. (Rahway, NJ)
- …closely with other functional area representatives to negotiate timelines and strategy for clinical supplies. Interacts with key partner organizations such as ... clinical development, regulatory , quality and other supply chain areas to address...supply chain areas to address clinical supply and/or change management related topics. Responsible and accountable for establishing the… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …authority and trust Serve as the expert on social media channel performance, risk management , competitive analysis, and emerging best practices to inform ... for the better. The Position The Associate Director, Consumer Social Media Strategy is a high-impact, hands-on leadership role responsible for the development,… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …improvement, project management , change management , and risk management .Responsibilities:Leadership, Direction, and Strategy : Is accountable ... study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards… 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
- 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)
- …in data analytics relating to sourcing initiatives.Strong understanding of risk management processes and experience developing mitigation strategies.Skilled ... of Global Sourcing and will develop and execute a long-term category strategy supporting ongoing and future manufacturing efforts such as process automation.Key… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and external vendors/contractors Ensure seamless operations and timely delivery of safety data Risk Management Act as the primary point of escalation for Medical ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Team. Relationship Reports directly to Head of PV Case Management . This role involves the oversight of case handling… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …can clearly convey the status of security and related issues surrounding enterprise risk management decisions to all levels of the organization including ... Essential Functions Support the Security Director's efforts to develop an effective strategy to assess and mitigate risk , manage crises and incidents,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- HSBC (New York, NY)
- …Americas Finance Leadership Team, senior management in Global Finance, Enterprise Risk Management , Internal Audit, External Auditors and regulators + Have ... NFRs include, but are not limited to, Financial Reporting Risk , Regulatory Reporting Risk , Model...Americas Finance Leadership Team + Manage a team of risk management experts across multiple locations and… more
