- Insmed Incorporated (NJ)
- …You'll Do: Lead the DSPV Medical Safety Strategy and Benefit- Risk Management group providing strategic direction, oversight and leadership across ... abstracts, and presentation materials. Lead the development and ongoing review of Risk Management Plans (RMPs), Risk -Evaluation and Mitigation Strategies… more
- BioAgilytix (Durham, NC)
- …The Cybersecurity Lead will unify existing policies into a streamlined, risk -based framework, ensure compliance with standards such as ISO 27001, GDPR, and ... Legal, Finance, Lab Operations, and external vendors.Pragmatic problem solver with risk -based prioritization, vendor/contract management experience, and a bias… 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 ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Category Sourcing Lead as part of the Global Operations team based in Raritan, NJ. Role… more
- Merck & Co. (Rahway, NJ)
- …operationsNew Products including supply chain design, operations and/or planning - Risk Management and Business/Financial acumenGreen Belt or Black BeltRequired ... New Product Introduction (NPI), New Product Introduction Process, Operation Risk Management , Pharmaceutical Management , Pharmaceutical Manufacturing,… more
- Insmed Incorporated (NJ)
- …impact public company reporting and internal controls.While Compliance maintains broadly Enterprise Risk Management (ERM), Internal Audit will perform a critical ... of SOX requirements, internal control framework (COSO), GAAP and risk management methodologies.Excellent analytical, problem-solving and critical thinking… more
- Insmed Incorporated (NJ)
- …with business objectivesAs the strategy evolves, prepare alternative development and risk management scenarios, project updates and options and recommendation ... matrix organization, driving decision making, facilitating issue resolution, problem-solving, risk management , contingency planning and decision-makingLead and… more
- Capital One (Goochland County, VA)
- …their game in Information Security. You are pragmatic and practical in your understanding of risk and security, but also willing to know when to pull in experts and ... with Cloud Service technologies like Storage Services, Security & Access Control Management , Container Services, and API Implementation and Management . You are… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …performance metrics to ensure departmental KPIs and regulatory compliance are met Lead deviation management activities, including root cause analysis and ... issues, and process improvements related to patient safety. Also support case management activities within US Patient Safety Team. Relationship Reports to the Head… 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, ... Process for the respective business areas.Responsibilities:Leadership and Project Management : Lead the end-to-end quality execution across Medical Affairs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the art presentation skills, power point, Visio, budget, resources, algorithms, projections, risk management and mitigation. Operational Oversight and ... and manage presentations and communications for key leadership meetings, and lead change initiatives by deploying operational excellence methodologies across… 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 regulatory ... Raritan, NJ. Role OverviewThis position will be responsible for providing project lead support for strategic initiatives and capacity expansion activities at the… more
- Eisai, Inc (Nutley, NJ)
- …reviews of commercial call logs and HCP payment records Serve as the operational lead for Eisai US's Compliance Monitoring Program, managing internal resources ... Agility, Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management , Mentoring/ People Development, Stakeholder Management… more
- Merck & Co. (Rahway, NJ)
- …aseptic qualification and performing environmental monitoring.Ability to develop and lead others.Ability to be flexible and understand risk .Collaboration: ... members and partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the area and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …acumen with experience managing budgets, forecasts, and headcount planning. Risk Management : Ability to identify, assess, and mitigate operational and ... the fast pace of change, balancing day to day operational demands with the need to extend and improve...and demonstrated passion for creating new medicines.Leadership & People Management : Proven ability to lead cross-functional teams,… more
- Insmed Incorporated (NJ)
- …expertise in root cause analysis, investigations, change control, and Quality risk management .Direct experience with clinical manufacturing, analytical method ... Establish QA-QA relationships and checkpoints for critical CDMOs and service providers. Lead or support Quality Agreements, risk assessments, audits, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …its application to drug development required to deliver time, cost, quality, and risk management to teams.Demonstrated results in creating and managing complex ... based in Raritan, NJ. Role OverviewThis position will be responsible for providing operational excellence project management support to the cGMP Clinical and… more
- Insmed Incorporated (San Diego, CA)
- …regulatory representative on cross functional teamsCommunicating regulatory strategies and risk assessments to cross-functional teams and senior leadership, as ... with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program Management , and external consultants to align regulatory results and ensure… more
- Insmed Incorporated (NJ)
- …and external audits related to PV activities based on the output of the risk assessments. Lead or co- lead internal and external pharmacovigilance audits (such ... agency questions resulting from inspections.Proactively identify and report systematic issues. Lead and/or assist in operational continuous improvement… 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 ... and implement a company-wide procurement strategy to optimize vendor spend, enhance operational efficiency, and mitigate risks. Lead high-value negotiations with… more
- NorthMark Strategies (New York, NY)
- …This role will support the development and execution of best-in-class insurance and risk management strategies across the organization, with a focus on Owner ... and alternative risk transfer strategies. Requirements: Bachelor's degree in risk management , Insurance, Finance, Business Administration, or a related… more
