- Globus Medical, Inc. (Audubon, PA)
- …specifications for new product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project + Managing all ... remaining in full compliance with Globus quality system and other applicable regulatory bodies + Designing and developing instruments and implants using Pro/E… more
- Penn Medicine (Bala Cynwyd, PA)
- …information.Other/ Regulatory :-Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, ... LCGME, SCGME, etc) -Flexible and readily adopts new processes and engages in practice operation changes. Credentials: Required: + HS Diploma/GED (required) + Completion of an accredited Medical Assistant program (or higher level equivalent). Equivalent… more
- Penn Medicine (Kennett Square, PA)
- …recovery of missing charges.Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, ... SCGME, etc.)Staying current with communications from the Patient Access Management Team while remaining flexible and readily adopts new processes and engages in practice operation changes.Coordinates clinical and administrative aspects of the new patient… more
- ThermoFisher Scientific (Nazareth, PA)
- …matrix. + Ensures policies and procedures are followed maintaining compliance with regulatory and operational procedures. + Reviews all internal reports to measure ... are met. + Ensures storage of materials is in keeping with State and Federal FDA , Board of Pharmacy, DEA, ATF, EPA and OSHA regulations. + Delivers with decision… more
- United Therapeutics (Harrisburg, PA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... + Conduct field rides within field regions with direct reports to evaluate regulatory compliance and abilities to deliver 'best in class' training and education +… more
- NTT America, Inc. (Pittsburgh, PA)
- …project governance frameworks and managing compliance with industry standards such as GxP, FDA 21 CFR Part 11, and ISO. * Experience with project financial ... resource planning. * Establish and enforce governance frameworks to ensure regulatory compliance and standardized delivery processes. * Collaborate with IT leaders,… more
- IQVIA (Pittsburgh, PA)
- …(samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. + Maintains accountability for all pharmaceutical ... samples in accordance with FDA and PDMA guidelines. + Utilize the sales automation system to document call and program activity. + Complete initial and ongoing… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... well with others. + Has the aptitude to learn semi-rigorous regulatory and process training requirements, demonstrate understanding, and follow instructions exactly… more
- Charles River Laboratories (Horsham, PA)
- …with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling ... proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal… more
- Charles River Laboratories (Horsham, PA)
- …with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling ... proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal… more