- Insmed Incorporated (San Diego, CA)
- …technical expertise and system documentation.Ensure data integrity, system reliability, and regulatory compliance across all phases of clinical development.Team ... future of science, we're in. Are you?About the Role:The Associate Director, EDC Programming will lead and oversee EDC...CFR Part 11, and CDISC ODM Standards.Data Quality & Compliance : Ensure EDC systems comply with regulatory … more
- Eisai, Inc (Baltimore, MD)
- …and system standards within the department to ensure reliability and compliance with company standards and governmental regulatory requirements. ... internal groups and coordinate calibration activities to support ongoing compliance , validation activities, operations activities, maintenances schedules, new equipment/instrument… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …product profile (TPP) development, due diligence projects, and clinical- regulatory compliance . ResponsibilitiesEssential Duties and Responsibilities Clinical ... success etc.Provide expert recommendations based on scientific and medical analysis. Regulatory Compliance : Ensure adherence to FDA guidelines for 505(b)(2)… more
- Merck & Co. (Durham, NC)
- …compliant supply of commercialized products for the benefit of patients. The Associate Director of Equipment Engineering is integral to this mission. The successful ... packaging process and equipment issues, optimizing processes, and ensuring compliance . Effective collaboration with site-based and above-site based functional teams… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-We are seeking a strategic and technical leader with ... Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to… more
- Eisai, Inc (Memphis, TN)
- …career evaluation, coaching, mentoring, performance management and talent review. Ensure compliance with regulatory and other ethical guidelines relevant to ... your profile, we want to hear from you. The Associate Director/Director, MSLs is responsible for the leadership, direction...the pharmaceutical industry, and to ensure compliance with Eisai policies & procedures and standard operating… more
- Cipla (Central Islip, NY)
- …working outside of Cipla's US Subsidiaries or Affiliates Job Title SCM Procurement- Associate Buyer Organization Name Invagen - A Cipla subsidiary Location New York, ... and Services, ensuring cost-effective purchasing while maintaining quality and compliance standards. This role involves supplier management, negotiation, rate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical ... against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile… more
- Merck & Co. (North Wales, PA)
- …Guides and instructs the National Account Executives, Customer Managers, Associate Directors, and Customer Account Representatives in understanding the elements ... system upgrades, 3PL Distribution Transitions, Key Product Launch Initiatives, Legal/ Regulatory (340B) Adherence Initiatives).- Required - Bachelor's degree Master's… more
- Twist BioScience (South San Francisco, CA)
- …company quality systems, and other company policiesPrepare for and participates in compliance auditsFollow regulatory and ISO 13485 requirementsWhat you will ... We are looking for an outstanding QA Associate to join our Operations Team. The QA...Microsoft- word, excelExperience in preparing for or participating in compliance audits and/or inspections by regulatory agencies.Excellent… more
