- ManpowerGroup (Irving, TX)
- …compliance with US Customs and related trade regulations (19 CFR, 15 CFR, FDA , USDA, etc.) and supports continuous improvement through regular audits and data ... analytical thinking + Familiarity with US import/export regulations (19 CFR, 15 CFR, FDA , USDA) + Clear communication and time management skills + Bachelor's degree… more
- Kedplasma (Bedford, TX)
- …Director. Operates within the scope of EU Guidance on Good Manufacturing Practices and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... that meet the criteria of normal plasma donors in accordance with SOPs, the FDA , OSHA, CLIA and cGMP and company policies as well as educational experience. +… more
- Sumitomo Pharma (Austin, TX)
- …goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and ... Regulatory Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions, clinical study reports, and NDA/MAA filings. +… more
- Bayer (Dallas, TX)
- …Medical Inquires in collaboration with Medical Communications; + Adherence to SOP and FDA guidance for distribution of scientific information; + Adherence to SOP and ... is preferred; + Experience in GI Oncology and Precision Medicine + Working knowledge of FDA , OIG requirements; + A minimum of 1 year MSL experience or 2 years… more
- Cardinal Health (Austin, TX)
- …to update manufacturer knowledge such as IPD Analytics, Evaluate Pharma, IQVIA, Medi-Span, FDA Orange and Purple Books, and more. + Conduct secondary research (eg, ... industry knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions and approvals),… more
- Houston Methodist (Houston, TX)
- …safety. **FINANCE ESSENTIAL FUNCTIONS** + Assures study conduct meets appropriate IRB, FDA , ICH and agency guidelines. + Utilizes resources with cost effectiveness ... conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports more than 1,387 clinical research… more
- Merck (Austin, TX)
- …response to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies. The successful candidate for this position ... Cattle, Biopharmaceuticals, Cattle Feeding, Cattle Production, Customer-Focused, Data Analysis, FDA Regulations, Feedlots, Field Sales Support, Livestock Management, Nutritional… more
- United Therapeutics (Houston, TX)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... production facility + Experience interfacing with the US Food and Drug Administration ( FDA ) and, as appropriate, ex/US regulatory agencies + Strong knowledge of cGMP… more
- United Therapeutics (Austin, TX)
- …daughter's pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... train lower to senior level employees **Preferred Qualifications** + Proficient knowledge of FDA regulations, including 21 CFR 1271 and 21 CFR 312 **Job Location**… more
- CSL Plasma (Port Arthur, TX)
- …to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA , and other regulations, as applicable, and develop center responses for ... regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA , GHA, HIPAA, and OSHA. + Maintain confidentiality of all personnel, donor and… more