- 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)
- …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)
- …member of the Technical Operations team, responsible for ensuring adherence to regulatory requirements and internal quality standards across cell and gene therapy ... CAR-T process technologies with a strong focus on compliance auditing, risk assessment, and continuous improvement.The Compliance Auditor will conduct internal… 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
- 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. (Rahway, NJ)
- … strategy and plans for assigned projects/products. Effectively communicates CMC regulatory strategy , risk , mitigation, and overall plan to the ... both internally and externally with broad expertise in CMC regulatory strategy and dossier management ... Regulatory Compliance Audits, Regulatory Requirements, Regulatory Strategy Development, Research Development, Risk… more
- Merck & Co. (Rahway, NJ)
- …filing and launch strategy , long-range demand vs capacity planning, integrated risk management , cost of goods projections, post approval change management ... process and method technical changes, robustness/quality/ productivity projects. Manage product supply risk through Integrated Risk Management (IRM) and… 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)
- …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)
- …Pharmaceutical Packaging, Risk Communications, Risk Evaluation And Mitigation Strategy (REMS), Risk Management {+ 5 more}-Preferred Skills:Job ... 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)
- …leader to shape and drive innovation across the Biologics pipeline, strategy , and science.Anticipate and solve scientific and technical challenges across projects ... of clinical development, as well as process characterization and regulatory filings for successful commercialization.Improve upstream processes by increasing… more
- Merck & Co. (Rahway, NJ)
- …Production Planning, Project Management , Project Procurement Management , Regulatory Compliance, Risk Management , Strategic Procurement {+ 5 ... category strategy alignment, sourcing and contracting execution, contract and claims management , project and risk management practices, and supplier… more
- Merck & Co. (Rahway, NJ)
- …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
- 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
- Formation Bio (New York, NY)
- …CMOs, software vendors, and other biotech service providers. Knowledge of contract law, risk management , and compliance in vendor agreements. Ability to work ... has deep experience in procurement, strategic sourcing, and vendor management within the biotech, pharmaceutical, or life sciences industry.Responsibilities Develop… more
- Reklame Health, Inc (New York, NY)
- …implement initiatives to enhance clinical workflows, patient outcomes, and satisfaction rates. Risk Management : Identify and address operational risks in care ... to provide culturally competent behavioral health care addiction care, medication management , crisis intervention, and care coordination for people working towards… more
- JPMorgan Chase (New York, NY)
- … Regulatory Strategy Lead within the Commercial and Investment Bank Regulatory Engagement Management team, you will be responsible for leading ... Bring your expertise to JPMorgan Chase. As part of Risk Management and Compliance, you are at...stakeholders and will be responsible for executing the overall strategy for regulatory engagements. In this role,… more
- Dow Jones (New York, NY)
- …complex and evolving global landscape. We have created a new Director of Business Management & Commercial Strategy , Risk Journal position. Based in New ... risk areas, including sanctions, anti-corruption, financial crime, cybersecurity, regulatory intelligence, and geopolitical, economic, and supply chain risks. The… more
