- Stanford University (Stanford, CA)
- …world of health care in the cancer arena. Reporting to the Clinical Research Manager , the Clinical Research Coordinator 2 will be conversant in the goals, mission ... investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. _* -… more
- Nuvance Health (New Milford, CT)
- …customer satisfaction. Responsibilities: * Under the Medical Director and Operations Manager , supervises the daily operations of assigned laboratory to insure ... * Ensures section compliance with all regulatory requirements (ie FDA , TJC, CAP, State of CT, NYS) by actively...improvement. * Prepares and submits various reports (ie QA, FDA reportables etc.) defined at the section level. *… more
- BeOne Medicines (Pennington, NJ)
- …required. + Any other assignments as are determined by the manager . **Education/Experience Required:** + BA/BS in science, biochemistry, biotechnology, biology, ... to internal and external teams + Knowledge of regulations and guidelines of FDA , EMA, ICH, PDA. + Demonstrated experience working in cell culture laboratory or… more
- The Hershey Company (IN)
- …directing shift mechanics. The Maintenance Supervisor will work with the Maintenance Manager to support the maintenance strategies, drive processes in support of the ... and practices to maintain asset performance * Follow all FDA health and OSHA safety regulations and effectively stay...CMMS preferred * Food/Snack industry experience and understanding of FDA , OSHA, and SQF regulations. * Technical expertise or… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …needs relative to USP's mission and strategies. + Responsible for compendial engagement with FDA on behalf of USP and works with GEA and others to manage ... interactions and ensure a continued strong relationship with FDA . + Performs the responsibilities of executive secretariat to the Council of Experts and manages all… more
- ADM (Decatur, IL)
- …results in a timely matter. + Support and comply to all applicable FDA , GMP, USP, Biosafety, and OSHA requirements. + Follow laboratory standards and maintain ... software). + Maintain awareness and adhere to all applicable FDA , GMP, USP, Biosafety, OSHA and employer standards and...or work at the location, please notify the hiring manager . Excited about this role but don't think you… more
- Fresenius Medical Center (Lawrence, MA)
- …and Regulations such as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning and implementation of risk ... external personnel in own area of expertise. . May escalate issues to supervisor/ manager for resolution, as deemed necessary. . Reviews and complies with the Code… more
- Curia (Albuquerque, NM)
- …efficiency, and ensure compliance with industry standards such as cGMP and FDA regulations. Essential Duties and Responsibilities: + Develop batch records for ... in the process to the attention of the shift supervisor, engineering manager , and/or quality assurance. Education and/or Experience: + Bachelor's degree in Biology,… more
- Mentor Technical Group (PR)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations ( FDA , EMEA). + Assures a streamlined and continuous process flow of… more
- Lundbeck (Deerfield, IL)
- …professionals, payers and policy makers. This is an opportunity for a seasoned manager with rare neurology launch experience to lead a Medical Affairs team that ... disease alliances and policy groups (eg, Rare Disease Caucus, PFDD Consortium, FDA Rare Disease Center of Excellence) + Highly proactive and solutions-oriented,… more