- Penn Medicine (Yardley, PA)
- …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: + Basic Cardiac Life Support (Required) + Certified Nurse Aid (Required) Education or Equivalent Experience: + HS Diploma/GED (Required) + In lieu of certification, must be a nursing student matriculated… more
- Penn Medicine (Berwyn, PA)
- …all federal, state and local regulatory standards and requirements, including DOH, TJC, FDA , HIPAA, HCFA, DPW, OSHA and others for practices under their leadership. ... + Complies with yearly education requirements including HIPAA, OSHA, Safety, and CLIA. + If applicable, manages the audit/survey process for the practice(s) Change Management + Provides support to entity and practice leadership to proactively develop change… more
- University of Pennsylvania (Philadelphia, PA)
- …final follow-up. Secure signatures and forward documents/forms (eg, FDFs, PSPs, FDA 1572, etc.) to appropriate destinations; maintain Delegation of Authority log. ... + Participate in research meetings (eg, team, disease-site, etc.) and Sponsor/CRO teleconferences. Provide coverage and support to meet departmental and organizational staffing needs (ie lunches, sick calls, vacations, or when a specific team member's workload… more
- University of Pennsylvania (Philadelphia, PA)
- …mission. Prepare draft PS-IDE applications for faculty review and submission to FDA . Draft components of clinical protocols and informed consents documents in ... collaboration with faculty. + Regulatory-Financial-Training/Continuing Education: Negotiate clinical trial agreements and budgets; conduct study initiation; maintaining study regulatory binders; submission of all regulatory paperwork to our institutional… more
- Oberg Industries (Freeport, PA)
- …and we are ISO 9001:2015, ISO 13485:2016, and AS 9100 Rev. D certified, ITAR and FDA registered. Come be part of the next chapter in our Oberg Story! OBERG BENEFITS: ... At Oberg Industries, LLC employees enjoy a comprehensive benefits package including: + Competitive Pay + Medical, Dental and Vision Insurance (no premiums paid) + Medical benefit opt-out with Reimbursement option + Health Savings Account (HSA) + Short & Long… more
- University of Pennsylvania (Philadelphia, PA)
- …research. + Provide preparation support for inspections by external bodies such as the FDA , EMA, the NCI and CTEP. + Produced deliverables and take actions following ... strict deadlines for all tasks to ensure compliance with NCI requirements. + Mentor junior compliance team staff members and work collaboratively with other DOCM functional teams. + Perform additional duties as assigned. Qualification + Bachelor's degree or… more
- University of Pennsylvania (Philadelphia, PA)
- …protocol compliance and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines. Clinical Research Coordinator B is expected to perform ... the duties above with the additional expectations of effectively and independently managing multiple trials while also assisting other coordinators as needed. The CRC B will demonstrate leadership skills, be able to identify common challenges, brainstorm… more
- Cardinal Health (Harrisburg, PA)
- …+ Review marketing materials related to customer services and FDA approved pharmaceuticals. + Review Business Associate Agreements, Confidentiality Agreements ... and Information Security Agreements **_Qualifications_** + 10+ years of experience preferred + Law firm or in-house healthcare experience preferred, including commercial transactions and fraud and abuse compliance expertise + Experience working with Group… more
- Sumitomo Pharma (Harrisburg, PA)
- …Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency ... in BASE SAS and R, or other statistical software is advantageous + Effective verbal and writing skills **Education and Experience** + PhD or MS in statistics or biostatistics related field required. + PhD with 0-3 years or MS with 3 years related experience or… more
- PCI Pharma Services (Philadelphia, PA)
- …new or improvement/expansion of existing assembly and packaging processes to deliver FDA compliant production capacity on time and within budget according to ... business plan. + Plan and manage capital plan for facility and production equipment related spending to assure production can meet new product development, equipment commissioning, product launch, and contract packaging requirements. + Works with global… more