- Insmed Incorporated (San Diego, CA)
- … representative on cross functional teamsCommunicating regulatory strategies and risk assessments to cross-functional teams and senior leadership, as ... strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in… more
- Merck & Co. (Rahway, NJ)
- … Compliance , Pharmacovigilance, Pharmacy Regulation, Prioritization, Regulatory Compliance , Regulatory Reporting, Risk Communications, Risk ... or external stakeholders (eg, Competent Authorities) for products for which the Senior Specialist is responsiblePV Statement preparation in compliance with… more
- Merck & Co. (Durham, NC)
- …Engineering Standards, Good Manufacturing Practices (GMP), Manufacturing Process Validation, Regulatory Compliance , Root Cause Analysis (RCA), Strategic ... risk mitigation, deviation management, technical protocols/reports, and BLA/MAA regulatory license documents.-Strong ability to collaborate and support teams… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director ... talented and dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development and review of regional / global policies and procedures. Ensure compliance with all Company and Regulatory requirements.Work with outsourcing ... other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to… more
- Merck & Co. (Rahway, NJ)
- …Asset Regulatory Management Successfully collaborate and lead resolution of Regulatory , Reputational (ie Public Relations), Compliance and other Asset issues ... Job DescriptionThe Global Senior Director of Medical Affairs (GDMA) for Melanoma...advances. The GDMA coordinates medical affairs activities to resolve regulatory , reputational, ethical, and other asset management issues and… 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. (San Diego, CA)
- …Analysis, Ethical Standards, ICH GCP Guidelines, Medical Writing, Motivation Management, Regulatory Compliance , Regulatory Documents, Science, Scientific ... 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)
- …and/or validations across vaccine and biologics programs including quality risk assessments/gap analysis.Provide sponsorship of both in-line and pipeline analytical ... support Process Performance Qualification (PPQ)Global launch or supply experiencesSupporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple… more
- Merck & Co. (Rahway, NJ)
- …Analysis, ICH GCP Guidelines, Management Process, Medical Writing, Process Improvements, Regulatory Compliance , Risk Management, Social Collaboration, ... proactively and result in outcomes that demonstrate the Company's dedication to regulatory compliance .Ensures that a cross-functional team (eg Quality &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …role involves deputizing for the Sr. Director, representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory ... audits, and high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the… more
- Merck & Co. (Rahway, NJ)
- …and with external suppliers. Understand and apply regulatory / compliance requirements relative to design controls and risk management activities. ... Job DescriptionJob Description The Senior Scientist, Device Design Control Lead, is a...Prepare materials for program presentations for management review and regulatory submissions, ensuring clarity and thoroughness. Lead the implementation… more
- Repligen (Waltham, MA)
- …Notifications (SCNs)Evaluate and manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate ... growing Supplier Quality team. You will a key role in ensuring the quality, compliance , and performance of Repligen's global supplier base. This is an opportunity to… more
- Merck & Co. (Rahway, NJ)
- …risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen ... challenges, proactively prioritizing, interrogating and mitigating risks across technical, regulatory and operational factors.- Conducts options analysis and provides… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager, and Manager.Oversee the hiring, development, and performance management… 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 ... procurement policies, procedures, and governance frameworks to ensure consistency, compliance , and cost discipline. Collaborate with finance, legal, R&D, and… more
- Merck & Co. (North Wales, PA)
- …Budgeting, Project Management, Project Planning, Project Scheduling, Project Strategy, Regulatory Compliance , Results-Oriented, Risk Management, Software ... Manager & Portfolio Lead, the core responsibility of this senior Project Manager (PM) role will be to manage...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …operations and/or large facility builds or renovations.A thorough understanding of regulatory / compliance expectations across all phases of product development ... administrative processes.Support the development of GMP Documentation such as:- Risk Assessments, Batch Records, Sampling Plans, Qualification Documents, and… more
- Merck & Co. (Rahway, NJ)
- …development, tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting, appraising, ... network internally and will advance a culture of scientific excellence and compliance with our company's procedures for recording time, data entry, and trainings.… 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 ... including deviation support, root cause analysis, customer complaint management, hosting customer/ regulatory audits and Certificate of Quality generation at an ISO… more
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