- Merck & Co. (Upper Gwynedd, PA)
- …(BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical ... - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal...Process Development, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory … more
- Merck & Co. (Rahway, NJ)
- …West Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our robust infectious disease and vaccines pipeline. - As an ... Associate Director , you will represent QP2 on cr o ss-...vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Eisai, Inc (Nutley, NJ)
- …research strategy across teams, to accomplish critical milestones across programs in compliance with Eisai's SOP's and regulatory guidelines.Direct program level ... profile, we want to hear from you. The Executive Director , Global Clinical Development resides within the Oncology at...opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase… more
- Twist BioScience (South San Francisco, CA)
- …continuous improvement, technical excellence, robust software development practices, and regulatory compliance .Software Development & Implementation: Oversee the ... Sr. Director , Manufacturing Execution System (MES) (Hybrid in South...our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the roleThe Director , Procurement will be responsible for establishing and managing a strategic ... procurement policies, procedures, and governance frameworks to ensure consistency, compliance , and cost discipline. Collaborate with finance, legal, R&D, and… more
- Repligen (Waltham, MA)
- …:Design, implement, and maintain effective internal controls over financial reporting (ICFR) in compliance with Sarbanes-Oxley (SOX) requirements.Ensure ... compliance with accounting standards and regulatory requirements, including SEC filings and tax regulations for multinational operations.Coordinate with external… more
- Eisai, Inc (Exton, PA)
- …close-out of documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations. The Associate Director is also ... Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of… more
- Eisai, Inc (Nutley, NJ)
- …exchange.Maintain scientific credibility and ensure operational excellence (20%) Ensure compliance with regulatory and other ethical guidelines relevant ... If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the planning and… more
- Eisai, Inc (Nutley, NJ)
- …and provide input into CME budget and website portal as needed. Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical ... your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the...industry, and to ensure compliance with Eisai policies & procedures.Provide support for new… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …customers. Relationships This position reports into a Vice President or Sr. Director within the National Account Market Access Teams. Internally, this position has ... Reimbursement), HEOR, Marketing, Commercial Sales, Medical Affairs, and Legal & Compliance . External relationships include Customers as outlined in the Purpose of… more
- Merck & Co. (Durham, NC)
- …Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director , External Manufacturing Operations will also assist in commercialization ... - Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across the Novo Nordisk US Operations, including ED&AA, IT, Ethics and Compliance , Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, ... 10-20% overnight travel required. Development Of People Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and… more
- Merck & Co. (Rahway, NJ)
- …clinical development, including study design, initiation, execution,- monitoring, analysis, regulatory reporting , publication, and presentation at national and ... Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory … more
- Merck & Co. (Rahway, NJ)
- …cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting , and publication.Specifically, the Director may ... Job DescriptionThe Director (Principal Scientist) has primary responsibility for the...Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance , Regulatory Reporting , Regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Call Center, Enterprise Insights, Supply Chain, Procurement, Public Affairs, Public Policy, Regulatory , Legal, IT, Trade, Patient Safety and Compliance . External ... Works closely with Enterprise Insights, Finance, Market Access, Legal, and Compliance to establish and monitor the program operations and related forecasts… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Intelligence is responsible for process improvement, technology, analytics, and reporting initiatives across the NovoCare® Patient Affordability and Access Support ... NovoCare® Patient Support Programs. Management of relevant data sets include compliance and database information integrity, program tracking, metrics, analysis, and … more
- Merck & Co. (Rahway, NJ)
- …clinical and commercial assembly equipment and processes for medical devices/drug delivery systems. Reporting to the Director responsible for this area, you will ... partners to achieve strategic business goals. Preferred Experience: Working knowledge of regulatory requirements and standards (21 CFR Part 4, 21 CFR Part 820,… more
- Robert Half Finance & Accounting (Wilmington, DE)
- …One of our successful clients within the financial services industry, is looking to hire a Director of Regulatory Reporting who can oversee and manage the ... GAAP, statutory, and regulatory updates. The ideal Director of Regulatory Reporting for...multitasking abilities. Major Responsibilities . Point of contact for regulatory requirements . Inform management on compliance … more
- American Express (Charlotte, NC)
- …which include: + Process review to identify control gaps and improvement opportunities for regulatory reporting processes. + Ensure compliance with the ... * Ensure compliance with Quality Assurance governed frameworks eg, Regulatory Reporting Governance policy, Self-Identified Re-filing Assessment Framework, … more
