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Provide practical and timely legal guidance on issues related to clinical, biometric, medical affairs, patient advocacy, regulatory affairs, pharmacovigilance, program and asset management, commercial development, pricing & reimbursement, sales, marketing, market access, patient services, and government affairs.
$306,700 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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MedPro is one of the largest recruiters of therapists and nurses from outside the U.S. MedPro currently has contracts with numerous organizations to service a multitude of facilities in the U.S. The company counts among its clients prominent healthcare facilities and organizations such as the Department of Veterans Affairs,HCA, University of Miami Hospital, and Tenet Healthcare.
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State of Delaware, Registered Nurse and Advanced Practice Registered Nurse + The candidate must successfully complete credentialing and payer enrollment as established through the University of Pennsylvania Health System's Office of Medical Affairs.
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Prepare and deliver technical presentations to internal and external organizations, including regulatory interactions for which the Principal Piping Engineer will provide subject matter expertise.
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Knowledge of and familiarity with U.S. and EU privacy and information security laws, regulations, and standards, including GDPR, ePrivacy Directive, CCPA, U.S. state and federal data privacy, security, breach notification, consumer protection laws, regulations and proposed legislation, and self-regulatory organizations such as DAA and NAI. Awareness of the privacy provisions of the Cable Act and the Communications Act preferred.
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Comply with Department of Public Health (DPH), The Joint Commission and other accreditation and regulatory agencies standards. Assists in the facilitation of external audits/site visits from regulatory agencies and payer sources.
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Transactional Support: Provide legal counsel on the environmental aspects of corporate transactions, including due diligence, risk mitigation, and regulatory strategy. Expertise:In-depth knowledge of state and federal environmental laws, including CERCLA, environmental compliance, and regulatory enforcement.
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To provide oversight and guidance to ensure the eTMF system aligns with Eisai TMF vision and transformation initiative and is compliant with ICH-GCP and regulatory requirements. This includes overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws and regulations.
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Leverages clinical knowledge and standard procedures to ensure timely attention to denials as requested by PBS and assists in the research and application of regulatory policies to support administrative appeals.
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You will report to the Senior Director, Site Head of Quality and work closely with Clinical Operations, our Contract Research Organizations, Contract Manufacturing Organizations, Medical Affairs, Regulatory, and Qualified Persons as needed.
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Other / Regulatory: Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA, HIPAA, HCFA, DPW, LCGME, SCGME, etc) The Certified Nursing Assistant (CNA) assists the practice manager and physicians in maintaining a patient/customer focus, supports the delivery of high-quality care, shares a passion for patient and customer centered care, and assists in meeting or exceeding patient satisfaction and financial/operational targets.
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You've got at least four years experience in the Life Sciences R&D industry in at least one of the following areas: research, clinical development/operations, pharmacovigilance, regulatory, medical affairs, medtech, patient services, MD&D (medical device and diagnostics) or related areas (CROs), health institutions, health technology companies, etc.
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Ensure that project requirements meet the regulatory requirement of the target filing country. Overview Overall responsibility for the analytical strategy, execution, tracking, and preparation of regulatory filing documents for the analytical part of cell and gene therapy product projects, ensuring timely and high-quality delivery Responsibilities.
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The Sr. Director, Global Medical Affairs- Hemophilia is a critical member of the Medical Affairs and Patient Engagement leadership team and is responsible for defining the Global Medical Affairs vision, contributions to the integrated strategy (which also includes market access and marketing components) & tactics, and integrated evidence plan that support Spark’s late-stage product development and commercialization objectives through Roche.
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The Program Director will monitor electronic medical records (EMR) for completion of clinical services and ensure regulatory compliance for the nursing home and related federal, state, and local regulations for behavioral health providers, as well as departmental and county policies and procedures.
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regulatory affairs jobs Title: affairs project manager Company: Jobget in Philadelphia, PA
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