- United Therapeutics (Harrisburg, PA)
- …daughter's pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality , regulatory affairs or a related area of study or 10+ years of… more
- WellSpan Health (York, PA)
- …based on research study requirements. + Assists investigators in evaluating the quality of care and compliance to protocol requirements. Follows by ensuring ... and informed consent documentation requirements are met as per the GCP, FDA and IRB guidelines. Registers and accomplishes randomization of patients enrolled in… more
- Geisinger (Danville, PA)
- …Physics Department. Job Duties + Meets and maintains the ACR and Mammography Quality Standards Act (MQSA) requirements for being listed as a qualified medical ... CT protocol reviews and recommends improvements for dosimetry or image quality . + Supports inspections/audits from regulatory/recommending bodies including TJC, PA… more
- Merck (West Point, PA)
- …compliance with industry standards and regulatory requirements (eg, ISO 13485, FDA regulations). Actively seek out, anticipate, and solve significant scientific and ... for all teams working on Autoinjectors, fostering collaboration among engineering, quality assurance, regulatory, and manufacturing teams across the CMC ecosystem.… more
- Globus Medical, Inc. (Audubon, PA)
- …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project...of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Designing… more
- Globus Medical, Inc. (Audubon, PA)
- …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project...of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Designing… more
- Cardinal Health (Harrisburg, PA)
- …to update manufacturer knowledge such as IPD Analytics, Evaluate Pharma, IQVIA, Medi-Span, FDA Orange and Purple Books, and more. + Conduct secondary research (eg, ... manufacturers and products. + **Executive presentations:** Consolidate information into high- quality presentations or memos with meticulous attention to detail.… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …across Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs, Research & Development, Legal, and Health Care ... and experience working with: + Various regulations (HIPPA, EU-MDR, FDA 21 CFR Part 803, 806, 820) + Various...cross functional teams and contribute to the resolution of quality -related issues in a timely and effective manner. +… more
- System One (Pittsburgh, PA)
- …proper data collection and analysis. + Ensure data integrity by monitoring data quality and completeness during the trial. Work closely with data management teams to ... all statistical work complies with relevant regulatory guidelines (eg, FDA , EMA) and Good Clinical Practices (GCP). + Use...get work done more efficiently and economically, without compromising quality . System One not only serves as a valued… more
- Globus Medical, Inc. (Audubon, PA)
- …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... product development + Create and maintain project plans and FDA complaint Design history Files (DHF) for each project...of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Design… more