- Insmed Incorporated (NJ)
- … management policies and frameworks aligned with organizational objectivesConduct enterprise-level risk assessments and develop mitigation strategies CSV Program ... We are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will… more
- Merck & Co. (North Wales, PA)
- …aligned to TA needs, LROP requirements, and platform evolution Able to drive risk mitigation strategies and represent a Digital/Analytics org in Legal, Privacy, ... Privacy Compliance, Quality Management, Risk Management and Mitigation , Risk Mitigation Strategies, Strategic Planning, Technical Advice, Vendor… more
- Merck & Co. (Rahway, NJ)
- …solve problems to achieve results Drive proactive risk management activities, including risk assessment, risk mitigation , and risk communication ... flaws including the ability to determine areas of potential risk , generate gap analysis and mitigation strategies...of potential risk , generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for… more
- Merck & Co. (Rahway, NJ)
- …combination products, and samples. Drive proactive risk management activities, including risk assessment, risk mitigation , and risk communication ... and detect critical flaws including ability to determine areas of potential risk , generate gap analysis and mitigation strategies In-depth knowledge of… more
- Merck & Co. (Rahway, NJ)
- …technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk mitigation , and risk ... and detect critical flaws including ability to determine areas of potential risk , generate gap analysis and mitigation strategiesIn-depth knowledge of global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and contribution to trial delivery, including but not limited to issue resolution, risk mitigation and escalation to Global Project Team (GPT), SCORE and ... breaches of GCP. Triage, resolve or escalate study issues / risk mitigations as per JOC/ESC and other established forums....accurate for assigned stud(ies).Ensure that a study level operational risk management plan is in-place and applies a smart-… more
- Merck & Co. (North Wales, PA)
- …Therapy, Healthcare Personnel (HCP) Marketing, Innovation, Leadership, Oncology Marketing, Risk Mitigation Strategies, Strategic Product Planning, Strategic ... to customer experience in the end-to-end patient journey.- Develop and implement risk - mitigation strategies and enhancement features to support optimal customer… more
- Cipla (Central Islip, NY)
- …Lead efforts to identify opportunities for cost savings, process improvements, and risk mitigation . Develop, manage and monitor RFQ (Request for Quotation) ... goals in alignment with global procurement strategies. Assess supply & supplier risk mitigation through continuous research and communication with various… more
- Usaa (Albuquerque, NM)
- …through proper documentation. Classifies members and/or non-members business and provide accurate risk management and risk mitigation solutions while ... work in an inbound sales environment advising business owners on insurance and risk management, using a full suite of Commercial Insurance Products to address each… more
- Bayer (Whippany, NJ)
- …and configuration of AI. Reviews the testing/validation of AI. Prepares an AI risk mitigation plan (as needed). Enforce relevant QSDs/LQSDs, documentation and ... training. Organization Readiness: Supports and monitor the organization against relevant QSDs/LQSDs and documentation by performing periodic spot checks and/or mock audits. Support the function throughout the audit and inspection process as well as assist with… more
- Insmed Incorporated (NJ)
- …teams; translate protocol design into demand/supply plans, contingency strategies, and risk mitigation across global marketsSupport the development and ... activitiesSupport regulatory filings (IND/CTA/IMPD), act as SME during inspections, perform risk assessments for supply interruptions and implement and complete … more
- Eisai, Inc (NJ)
- …internal teams and external partners, the Director drives operational excellence, risk mitigation , and inspection readiness while fostering cross-functional ... strategies that achieve cost efficiencies, improve vendor performance, and minimize risk .Manages vendor qualification processes and partner with Vendor Risk … more
- Repligen (Waltham, MA)
- …and key digital systems. This role drives the ITGC audit program, advises on risk mitigation strategies, and partners closely with Internal Audit, IT, Financial ... ensure "controls by design."Maintain ITGC narratives, process flows, and risk /control matrices.Identify and drive process improvements, automation opportunities, and… more
- Cipla (Hauppauge, NY)
- …qualifying manufacturing equipment (IQ, OQ, and PQ) and preparing necessary PQ protocols. Risk assessment and risk mitigation by performing FMECA (Failure ... modes, effects, and criticality analysis) Education Qualifications A bachelor's or advanced degree in pharmaceutical sciences, chemistry, or a related field is typically required. Experience 2-5+ years' experience Skills/ Competencies Proficiency with… more
- Aequor (Houston, TX)
- …out of plant. Identify and qualify alternate materials and/or components for either risk mitigation or because of obsolescence. Maintain adequate supply of ... purchased components through contact with Procurement and the Suppliers. Qualify tooling and equipment as required to assure capacity. Address any component or product quality issue assigned, determining root cause and completing corrective action. Address any… more
- Formation Bio (New York, NY)
- …and management methodologies, with a successful track record in their application and risk mitigation Proven experience in establishing and managing a quality ... the support and resources they need to succeed. Creating and implementing risk -based quality strategies that identify and address potential quality risks. Managing… more
- Insmed Incorporated (NJ)
- …Sheet, Investigator's Brochure and Risk Management Plans (RMPs), and Risk -Evaluation and Mitigation Strategies (REMS).Prepare responses to inquiries from ... Director will be responsible, globally, for implementing the safety and risk management activities for clinical development; be responsible for safety surveillance,… more
- Cipla (Fall River, MA)
- …chain management and regulatory affairs, responsible for launch planning, launch risk mitigation and launch supply readiness. Responsible for collaborating ... developments leading to development of commercial models. Lead and implement a risk -based approach towards assessment of projects, project milestones and stage gate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and implement opportunities for cost savings, process improvements, and risk mitigation .Directly support internal audits, regulatory inspections, and ... required.Prioritize sourcing activities based on business needs, criticality, and risk .Manage day-to-day operational decisions impacting procurement execution and supplier… more
- Insmed Incorporated (NJ)
- …and assess regulatory risks associated with product development and define risk - mitigation strategiesProvide regulatory guidance across functions throughout the ... R&D process and advise on the US IND and global CTA submission strategiesDirect the planning and coordination of global regulatory submissions, including clinical trial applications for multinational trials, core briefing packages, and global marketing… more
