- Sandoz Group AG (Princeton, NJ)
- …Performance Evaluations, Finance Acumen, Gmp Procedures, Goal-Oriented, Health Authorities, Inspection Readiness , Leadership, Logical Thinking, Major Incident ... personally. Join us as a Founder of our 'new' Sandoz! As the Associate Director , Market Product Quality you will be responsible for the execution of processes… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Medical Review Prospective & Retrospective Quality Review of cases Regulatory Intel & Inspection Readiness Maintains up to date knowledge of the regulations and ... you ready to make a difference? The Position The Director Medical Review oversees a team of Medical Reviewers...reports pertaining to Novo Nordisk Products. The Medical Review Director is a key Leadership Team member and advisor… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to ensure departmental KPIs and regulatory compliance are consistently met Audit & Inspection Readiness Support the preparation and execution of internal and ... external audits and regulatory inspections Ensure documentation and processes are audit-ready and aligned with global pharmacovigilance standards Physical Requirements 0-10% travel required. Development Of People Supervisory. Verbiage below applies only to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and ensure appropriate documentation Perform case follow-up activities Participate in inspection readiness and support audits/ inspection as required ... of assigned projects in Patient Safety. Relationship Reports directly to the Director , Patient Safety Case Management. This role involves the case handling and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …templates meet both Global and local regulatory requirements Supports audit and inspection readiness Develops and maintains company (safety) SOPs Business ... with SDEA requirements. Relationships This position reports to the Associate Director , Safety Contracts & Supplier Management. This position works closely with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …sites. In addition, this role will support Compliance initiatives, such as inspection readiness , metrics implementation and review, overall regulatory compliance ... landscape to stay informed of regulatory trends and developmentsAssist with inspection readiness efforts and program implementation across all sites.Manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study oversight and execution.Ensure their direct reports are maintaining a state of inspection readiness across all activities on their study and making sure ... measures in place to course correct where needed. The Director will be accountable to support SDL and employee...reports are properly trained, following process and SOPs. The Director will ensure the Senior Director , Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …applicable regulatory requirements, and other relevant guidelines.Is accountable for inspection readiness of DM programming documentation filed/archived ... areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …into an annual Quality Plan, including quality risk assessments and inspection readiness components for designated programs.Ensure proactive representation of ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of...during inspections and external audits. Ensure ongoing submission and inspection readiness for the respective Medical Affairs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …required to assure compliance with PV agreements. Participate in audit and inspection readiness activities. Provide input for remediating PV system deficiencies ... cited in audit/inspections. Implement effective corrective and preventative action PV Agreements and Contracts: Manages PVAs/SDEAs and maintains oversight of PV relevant contracts. Oversee and set standards for PV contract management. Review contribute to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and quality delivery and regulatory compliance of outsourced activities.- Ensures inspection readiness of all data management activities conducted internally ... areas centered around rare diseases and immune disorders. Summary The Executive Director , Data Management (Head of Global Data Management) sets the vision,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of continuous improvement in benefit-risk evaluation, and participate in inspection readiness activities.Responsibilities:This individual will be the main ... cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE)...a global and regional level as required.Support audit and inspection readiness activities as a subject matter… more
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Director of Inspection Readiness is responsible for ensuring ... cell therapy, and medical device operations. Reporting to the Senior Director of Inspection Readiness , this individual contributor role leverages extensive… more
- J&J Family of Companies (Titusville, NJ)
- …leadership and at governance meetings (eg TA governance, DC/IC). + Lead and ensure inspection readiness for program through risk identification and readiness ... more at https://www.jnj.com/innovative-medicine **We are searching for the best talent for Director , Program Delivery Leader - Post Approval Delivery Unit, to be… more
- System One (Basking Ridge, NJ)
- …Expert (SME) for safety surveillance and risk management for assigned product(s), through inspection readiness preparation, and may serve as the primary or ... Job Title : Associate Director , Clinical Safety Scientist (Contingent Worker) Job Schedule: Candidate can work 100% remote - preference would be EST/CST based… more
- Lilly (Branchburg, NJ)
- …provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly ... of a sterility assurance network or hub in global TSMS + Support inspection preparation and execution during health authority on-site or remote inspection … more
- J&J Family of Companies (Raritan, NJ)
- …to meet the portfolio objectives throughout the year. + Support regulatory inspection readiness , inspections, and CAPAs where relevant **Education and ... America **Job Description:** Johnson & Johnson, is recruiting for a Executive Director , Therapeutic Area Safety Head, Cardiopulmonary to be located in Raritan, NJ;… more
- Bristol Myers Squibb (Princeton, NJ)
- …+ Serve as mentor to other leads. + Ensure preparation for audit and inspection readiness + Ensuring diversity and inclusion in decision making, organization and ... Read more: careers.bms.com/working-with-us . **Position Summary** Position reports to the Director of Medical Communications within WWMH, of Global Medical Affairs… more
