- University of Rochester (Rochester, NY)
- …and complete source documentation in accordance with GCP and federal regulations ( FDA , NIH, OHRP) + Perform quality assurance reviews to ensure consistency between ... position adheres to national and international clinical research regulations including: FDA Clinical Trial Regulations + Office for Human Research Protections (OHRP)… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... with a Bachelor's Degree + Prior experience working in an FDA regulated pharmaceutical manufacturing environment + Organizational skills including, but not… more
- University of Colorado (Aurora, CO)
- …ensure compliance with requirements of the Food and Drug Administration ( FDA ), study protocols, department, hospital/clinical standard operating procedures and other ... Assists with Sponsor, Data Safety Monitoring, and Food and Drug Administration ( FDA ) audits and responses + Participate in subject recruitment efforts, including… more
- Stanford Health Care (Palo Alto, CA)
- …Ordering, Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA - approved indication (off-label ... use) require a patient-specific order in advance from the supervising physician. + After appropriate training, assists the supervising physician in the operating room (OR). + Acts as first or second assistant under the supervision of an approved supervising… more
- Bayer (Berkeley, CA)
- …including a current understanding of USP/EP, cGMP regulations, ICH, and FDA Guidance Documents. Provide support during internal/external audits; * Ability to ... management, Risk Management, etc.); + Expertise in cGMP and regulatory requirements ( FDA , EMA, ICH, etc.); + Expertise in performing investigative work; + Knowledge… more
- Valent BioSciences (Libertyville, IL)
- …of programs related to internal and external audits, including those by the FDA , EMA, ISO registrars, and other regulatory bodies. + Collaborate with R&D, ... and biosafety programs. Skills and Competencies + Deep understanding of FDA , EMA, ISO 9001/14001/45001, and other global regulatory frameworks. + Strong… more
- System One (Monmouth Junction, NJ)
- …involves operating packaging equipment, ensuring compliance with batch records and FDA guidelines, and maintaining accurate documentation. The position offers a ... and maintain batch records and other required documentation. + Follow SOPs, cGMPs, FDA standards, and safety procedures at all times. + Collaborate with production… more
- Abbott (Tipp City, OH)
- …nutritional products. + This position is accountable for complying with applicable FDA , GMP, OSHA and Abbott regulations, policies, procedures or guidelines You'll ... be accountable for meeting our compliance standards including FDA , OSHA and Abbott policies and procedures. **Shift** This is a **night shift position (6:30pm -… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …and presentations. Conduct verification and validation testing in accordance with FDA and ISO standards. Support regulatory submissions by documenting algorithm ... delivery systems, mechanical ventilators and anesthesia delivery systems. Experience with FDA design controls and IEC software lifecycle processes. Knowledge of… more
- AssistRx (Orlando, FL)
- …Market & Pipeline Intelligence + Conduct ongoing research on the FDA drug pipeline, clinical trial activity, company announcements, and market movements. ... strongly preferred. + Working knowledge of the drug development lifecycle, FDA approval pathways, and clinical trial registries. + Experience using 6sense,… more