- Merck & Co. (Durham, NC)
- …technical solutions and operational improvements to achieve targets for safety, compliance , supply, and productivity for the product franchise.This role requires a ... issues, help identify trends, and participate in the implementation of risk mitigation actions.Collaborate with functional teams to contribute to strategic… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. The Manager of Treasury and Risk Management monitors and updates various cash flows and procedures, including domestic and ... debt and investment instruments. The Manager of Treasury and Risk Management assumes responsibility for corporate cashiering, accounts-receivable deposits,… more
- Merck & Co. (Rahway, NJ)
- …or external stakeholders (eg, Competent Authorities) for products for which the Senior Specialist is responsiblePV Statement preparation in compliance with ... Regulatory Compliance , Pharmacovigilance, Pharmacy Regulation, Prioritization, Regulatory Compliance , Regulatory Reporting, Risk Communications, Risk … more
- Merck & Co. (Rahway, NJ)
- … lead resolution of Regulatory, Reputational (ie Public Relations), Compliance and other Asset issues management Substantive contributions to labeling committees. ... Job DescriptionThe Global Senior Director of Medical Affairs (GDMA) for Melanoma...close collaboration and alignment with the Value and Implementation lead . Support the Regional Directors Medical Affairs and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to ... ensure ongoing collaboration and communication with internal stakeholders. Detailing The Senior Director will ensure a robust communication plan including status and… more
- Merck & Co. (Rahway, NJ)
- …analytical technical transfer, and Biologics License Application preparation. Responsibilities Lead method transfers and/or validations across vaccine and biologics ... programs including quality risk assessments/gap analysis.Provide sponsorship of both in-line and pipeline...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (San Diego, CA)
- …of a clinical trial.-This may include:May serve as the clinical trial team lead -May lead team in key study planning, development, and execution elements ... reports, study close out activities).-Leads team for timeline management, risk identification and mitigation, issue resolution.-May facilitate and collaborate with… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionApplications are sought for a Process Engineering Lead position in o ur Reseach & Development Division Biologics Process Research & Development ... as an engineering resource for biologics operations, build strong equipment knowledge, lead projects, and provide guidance and training to operationalize the GMP… more
- Merck & Co. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within Research Laboratories is committed to rapidly delivering ... and engage with the scientific community to influence the field.As a Senior Principal Scientist, you will drive various strategic initiatives and translate… more
- Merck & Co. (Rahway, NJ)
- …real-time, proactive advice and guidance.Escalates potentially significant inspection findings/ compliance risks/impact to Company Senior Management.Develops the ... GCP Guidelines, Management Process, Medical Writing, Process Improvements, Regulatory Compliance , Risk Management, Social Collaboration, Strategic Planning,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical development processes through KQIs, demonstrating process control and ensuring compliance levels are met. Lead the process for reviewing and assessing ... for the Sr. Director, representing the Quality organization at senior levels. The Director plays a pivotal role in...high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description The Senior Scientist, Device Design Control Lead , is a crucial member of our team, responsible for spearheading design control ... Device Development and with external suppliers. Understand and apply regulatory / compliance requirements relative to design controls and risk management… more
- Merck & Co. (North Wales, PA)
- …executing CMC development plans.--Under the guidance of the CIPM Staff Manager & Portfolio Lead , the core responsibility of this senior Project Manager (PM) role ... Project Management, Project Planning, Project Scheduling, Project Strategy, Regulatory Compliance , Results-Oriented, Risk Management, Software Project Management… more
- Insmed Incorporated (San Diego, CA)
- …the regulatory representative on cross functional teamsCommunicating regulatory strategies and risk assessments to cross-functional teams and senior leadership, ... risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in alignment with Insmed's… more
- Merck & Co. (Rahway, NJ)
- …awareness of when to apply each.- Leverages scientific data to make disciplined risk -based decisions and shown to be capable of discerning between risks worthy of ... and information to others in an impactful manner with proven ability to lead complex discussions, influence stakeholders, and drive outcomes in the best interest of… 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 ... ensuring cost-effective and value-driven vendor partnerships. This individual will lead vendor negotiations, implement procurement best practices, and collaborate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager, and Manager.Oversee the hiring, development, and performance management… more
- Merck & Co. (Rahway, NJ)
- …network internally and will advance a culture of scientific excellence and compliance with our company's procedures for recording time, data entry, and trainings. ... proven talent development skills. Extensive experience as a drug substance lead for biologics pipeline programs. Strong capability in managing evolving timelines,… more
- Repligen (Waltham, MA)
- …internal and external audit schedules; serve as host for site auditsMaintain risk -based strategy for overall Quality compliance across the organization and ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology… more
- JPMorgan Chase (Tampa, FL)
- …will drive significant impact within the Asset Management business. As a Senior Test Lead within the Global Asset Compliance and Ops Risk Testing Center ... detailed compliance testing review reports. + Foster collaboration with Compliance and Operational Risk Officers on various engagements. This includes… more
