- 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
- Insmed Incorporated (San Diego, CA)
- … Regulatory Affairs, lead the development and implementation of global regulatory strategy plans to facilitate efficient and driven product developmentMonitor ... serving as the regulatory representative on cross functional teamsCommunicating regulatory strategies and risk assessments to cross-functional teams and… 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. (Durham, NC)
- …, Project Management Tools, Project Planning, Project Portfolio Management (PPM), Regulatory Compliance, Risk Management , Risk Management and ... transition plans to the new source of supply or for post-change supply) Risk Management Proactively identifying and mitigating risks and participating in… 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)
- …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
- BioAgilytix (Durham, NC)
- …roadmap, aligned to industry frameworks (NIST CSF, ISO 27001).Oversee governance, risk , and compliance activities, including policy development, regulatory ... environments to safeguard scientific operations.Manage vendor and third-party security risk , ensuring adherence to contractual and regulatory obligations.Define… 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
- Merck & Co. (Rahway, NJ)
- …and inspire accountabilityEthical, resilient, and committed to excellenceSkilled in risk management , team facilitation, and strategic planningExperience in ... will shape the future of biologics on a global scale.Key Responsibilities:Technical Strategy :-Deliver robust DS & cell bank process and analytical strategies for… 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)
- …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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study teamsDevelop best practices and lessons learned mechanisms within Clinical OperationsDevelop risk assessment & risk management and clinical project ... / global policies and procedures. Ensure compliance with all Company and Regulatory requirements.Work with outsourcing procurement management to optimize the… 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)
- …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
- 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
- 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
- AbbVie (Chicago, IL)
- …across Global Patient Safety.. + Advise the PSTs and other internal stakeholders on risk management regulatory strategy Qualifications + Health ... and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: Promotes risk management strategy excellence through...to risk minimization + Key advisor on regulatory aspects of risk management … more
- JPMorgan Chase (Newark, DE)
- …FRB, OCC, and FDIC, and work closely with stakeholders in Regulatory Strategy , Credit Risk Management , Operations, Finance and Technology to streamline ... Bring your expertise to JPMorgan Chase. As part of Risk Management and Compliance, you are at...and resilience. You'll be at the forefront of our regulatory efforts, delivering accurate risk metrics to… more
