- Fresenius Medical Care (Gresham, OR)
- …vision, core values and customer service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory and FMS policy requirements. ... care while maintaining cost-effective clinical operations in accordance with all legal, compliance , and regulatory requirements and programs. As the Charge… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audit activities which includes mock pre-approval inspections, routine ongoing GMP compliance audits and GMP regulatory inspections. Support the establishment, ... Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or CMOs. The incumbent… more
- Genmab (NJ)
- …regulations, and processes Ensures study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study ... the scientific need of a study/program while ensuring quality, consistency and compliance to CDISC standards and other industry standards that supports the exchange… more
- Legend Biotech USA, Inc. (Omaha, NE)
- …to healthcare professionals in accordance with Corporate, PhRMA, and OIG guidelinesStrict compliance with all regulatory agencies, state, and federal law is ... among peers by consistent application and modeling of the appropriate compliance , behavior, and conductPerforms all administrative functions required for the… more
- Wheels Contracting, Inc. (Banner Elk, NC)
- …guidance. This role is crucial in ensuring the accuracy of financial reporting and compliance with regulatory standards. xhqgsiq This role will also need to ... possess an operational perspective for understanding the corporate structure of multiple businesses rolling into a single loop entity. more
- SOFIE (Totowa, NJ)
- …pharmaceutical partners, they will ensure that these radiopharmaceuticals are in full compliance with all regulatory requirements (specifically, 21 CFR 211 and ... the application of scientific principles, and rationales, and adherence to regulatory requirements. Write clear Standard Operating Protocols (SOPs) for these… more
- Insmed Incorporated (NJ)
- …to the development and review of regional/global policies and procedures. Ensure compliance with all Company/ Regulatory requirements & TMF quality standards.Work ... conduct (including, but not limited to, ICH / GCP and regulatory requirements).Experience managing staff and providing oversight of department activitiesEffectively… more
- Insmed Incorporated (NJ)
- …lifecycle management and remain in a validated state per associated SOPs, regulatory and security requirements. \tEnsure compliance and operational efficiency of ... validated systems through participating in release management, change control, periodic reviews, and audit trail reviews.What You'll Do: Provide strategic leadership and decision making on CSV strategy using Insmed's risk-based approach. Provide oversight and… more
- Insmed Incorporated (NJ)
- …in a validated state (eg SDLC, IT Change Control) per associated SOPs, regulatory and security requirements. \tEnsure compliance and operational efficiency of ... validated systems through participating in release management, change control, periodic reviews, and audit trail reviews.What You'll Do: Develop risk-based validation strategies for system implementation and changes following CSV SOPs and Work Instructions… more
- NY CREATES (Albany, NY)
- …and commercialization. Job Description: Job Description for Governance, Risk, and Compliance Specialist JOB SUMMARY The Senior Governance, Risk, and Compliance ... Specialist (GRC) is the organization's authoritative governance, risk, and compliance strategist and execution lead, responsible for maturing and operationalizing a… more
