Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Administrator, Regulatory Compliance

Expired Job

University Of Pittsburgh Medical Center Pittsburgh , PA 15201

Posted 2 months ago

Job Description:

Job Title: Administrator, Regulatory Compliance

Job ID: 728641

Status: Full-Time

Regular/Temporary: Regular

Hours:

Shift: Day Job

Facility: UPMC Health Plan

Department: Compliance & Ethics

Location: 600 Grant St, Pittsburgh PA 15219

Description

Purpose:

UPMC Health Plan is seeking an Administrator- Regulatory Compliance!

Under the direction of the Senior Director of the Corporate Compliance & Ethics Office, the Administrator, Regulatory Compliance monitors and researches compliance of UPMC Insurance Services Division with existing federal and state regulations and statutes for managed care and worker's compensation organizations. Incumbent functions as liaison with appropriate state agencies, oversees all regulatory filings, reporting, licensing and coordinates service area expansions.

  • Law background preferred

  • Previous experience researching and analyzing managed care and worker's compensation laws and regulations preferred

  • Previous experience drafting/modifying policies and procedures to meet regulatory standards preferred

  • Previous experience translating regulatory or technical standards into simple, clear written instructions preferred

Responsibilities:

  • Coordinates obtaining licenses to offer health plans and worker's compensation in new states (e.g., HMO, PPO, third party administration, utilization review)

  • Researches state laws and regulations related to licensure

  • Assist business units to incorporate expansion state regulatory requirements into operating policies and procedures

  • Oversee preparation of quarterly and annual regulatory reports required by license

  • Reviews drafts and/or drafts (as requested) policies and procedures from a regulatory/compliance perspective

  • Updates key management of regulatory changes/developments and implications of new health care, worker's compensation legislative initiatives to the functional areas of UPMC Insurance Services Division.

  • Works with Senior Director of Compliance and designated departments to coordinate compliance monitoring

Qualifications

  • Bachelors degree required.

  • Masters degree and/or paralegal certificate preferred.

  • Previous management/supervisory experience preferred.

  • Five years health insurance, government products, or regulatory review required.

  • Must have strong analytical and organizational skills, as well as problem-solving capabilities to verify that business plans and/or strategies do not place the company in violation of federal, state, or accreditation standards.

  • Excellent oral and written communication and computer skills.

Licensure, Certifications, and Clearances:

UPMC is an equal opportunity employer. Minority/Females/Veterans/Individuals with Disabilities

Salary Range: $30.89 to $52.76

Union Position: No

For the best application experience, we encourage you to apply for this job from a non-mobile device.


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Regulatory Compliance Manager

Bloodsystems

Posted 3 weeks ago

VIEW JOBS 10/30/2018 12:00:00 AM 2019-01-28T00:00 PRIMARY PURPOSE: Reports to the Hemophilia Center Director and coordinates research protocol activities for the Hemophilia Center. DUTIES AND RESPONSIBILITIES: * Performs all assigned duties in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management. * Assures quality customer service to all customers. * Maintains good attendance and punctuality per the absence policy. * Regulate & maintain research protocols/ informed consent documents and IRB approvals. Manage ongoing paperwork and/or electronic submissions for all types of clinical research trials (Phase I, II, III, IV studies). Write, submit and revise protocols and informed consent documents for retrospective, pharmaceuticals, other industry sponsors and multi-institutional studies to all review boards (IRB, MUH-CTRC, IBC-rDNA, PCI-PRC, CORID, other departmental scientific review committees) via required format (paper documents, electronic submission). Plan submissions using a timely and organized approach. Review preliminary documents and reports with the PI and nurse manager, for local study design to ensure compliance with current IRB, FDA, OHP regulations (i.e. included, but not limited to PK blood draw guidelines, standard of care practice, benefit/'risk assessments). Present any inconsistencies, obstacles or concerns to PI/management. Assist research team (PI & staff) with recognizing, tracking and reporting adverse events and protocol deviations to the review boards (local IRB (i.e. University of Pittsburgh), MUH-CTRC, Central IRB's (i.e. WIRB), IBC) and sponsor in a timely fashion. Interact with ancillary departments to ensure protocol compliance (fiscal review, rDNA office, investigational drug service, UPMC Clinical Trials office, University of Pittsburgh department of Hem/Onc, pharmacy department). Ascertain needs for IRB waivers (i.e. HIPPA, partial waiver of consent, etc). Correspond with various entities involved in study implementation, monitors, sponsor representatives, review boards, (IRB, MUH-CTRC, UPMC Clinical Trials office, fiscal review, IBC-rDNA committee, Department of Medicine, UPMC contracting). Ensure the certification of all principal and co-investigators, on the protocol. Assist PI/mentor in ascertaining module certification requirements for University of Pittsburgh students. Develop study flyers as needed. Meet regularly with the Director to review study protocols and progress and troubleshoot problems. Prepare weekly agendas and keep minutes of research meetings. * Coordinate & organize research safety data reports. Assist PI to Coordinate all HCWP local DSMB activities. Assist PI with compiling necessary FDA IND reports, and required documentation by utilizing current guidelines for annual FDA IND reporting. Maintain files of communication(s) between PI/site with FDA, and University (O3IS) office. This includes compliance reports, updated 1572's and other regulatory documentation. De-identify data. Assist PI in compiling enrollment reports, issues of concern, compliance RISE reports to University Departments, UPMC Clinical Trials office and other departments. Acquire up-to-date enrollment, data safety reports from sponsors for necessary submissions. Perform literary searches as directed by primary investigator. Maintain on-gong files of DSMB reports & meetings. * Research education and development. Maintain up-to-date information regarding federal regulations and ethical considerations and IRB policies related to the use of human subjects in research. Educate and advise HCWP staff regarding current regulations and policies governing human subject research. Assist and advise other sites on IRB submissions for multi-center protocols where HCWP is the central site. Advise PI and educated staff with the most current information concerning submission requirements and continued use of the University of Pittsburgh on-line submission tracking system (OSIRIS). Assist PI mentored students in IRB requirements and submissions. As directed by PI, assist with IRB submission(s). Attend IRB/MUH-CTRC/IBC-rDNA/University OCR educational meetings. Travel to conferences and study meetings and present information to team members. Attend necessary CTSI, IRB, CTO organizational meetings (as needed). Collaborate and educate others (internal and external) regarding study procedures/protocols, use of equipment and outcomes of study. * Clinical research and responsibilities. Assist research staff with recruitment, screening and enrolling patients (as needed). Assist research staff with scheduling, coordinating study procedures, (as needed). Ability to analyze complex issues, collaborate and advise with sound judgment. Assist PI and study team in the development of source documents, CRF's and required regulatory forms as required by study design. * Maintain on-going reporting of progress of clinical protocols. Inform all necessary individuals (sponsors, PI, research staff, IRB's) via mail, email, written reports, telephone calls, etc) of stages and status of HCWP protocols. Maintain up-to-date records of regulatory documents (including, but not limited to 1572's, confidentiality agreements, budgets, etc) for HCWP protocols. Collaborate with the study coordinator for site visits, monitoring, and audits including sponsors, IRB's, University of Pittsburgh departments (including compliance, O3IS, etc). Assist in preparation of formal responses. Preparation and distribution of weekly research agendas & minutes. * Confidentially agreements, contracts and budgetary duties. Track and maintain status and communications between parties (PI, sponsor, site(s) on the status of confidentiality agreements, study contracts, letters of indemnification, material transfer agreements, etc). Pre-review agreements as needed for study planning. Maintain fully executed copies of confidentiality agreements, contracts and study budgets for reference and regulatory documentation. Assist PI in fulfillment of reports as outlined in contract. Assist in preliminary budget development as it relates to study protocol. Maintain an active connection at MUH-CTRC and/or UPMC for budget and cost structure changes at UPMC services/facilities. Provide assistance in the organization and review of department costs/reviews to ensure protocol compliance and agreement between consent, protocol and contract. * Provide effective and responsive link to Regulatory Agencies: FDA, Recombinant DNA Safety review Board, NIH, and national and local investigational review board. * Engage in productive interaction with Pharmaceutical industry professionals including senior project managers, medical writers, clinical research project managers, scientific directors, Medical Directors and legal counsel for contract development. * Serve as the primary contact to other outside entities. Establish a primary contact process for new protocol submissions. Collaborate with the protocol design team to revise and review documents for the submission process. Recommend changes to protocol submission documents and process. Maintain a positive working relationship between HCWP and the vendors associated with regulatory submissions. * Performs all other duties, at the discretion of management, as assigned. REQUIREMENTS: Knowledge/Education * High School Diploma is required. * BS degree in a health or science related field preferred. Licenses/ Certifications Current RN licensing a plus. Experience * Five years relevant experience in biological sciences, medicine, pharmacology or related field preferred. * Three years' experience in clinical trials preferred. * Position requires previous pharmaceutical industry experience or other research related experience. * Experience with electronic submission (i.e. OSIRIS) a plus. * Previous experience with MUH-CTRC, UPMC CTO and University of Pittsburgh research a plus. * Office of Research and Human Protections (OHRP) and Food and Drug Administration (FDA) is essential or 2 years' experience in drug development, regulatory or clinical operations functions. Skills/Abilities * Must possess the skills and abilities to successfully perform all assigned duties and responsibilities. * Must be able to maintain confidentiality. * Strong communication, presentation and computer and data base knowledge skills are required. * Exceptional writing, planning, and organizational skills are required to prepare clinical study protocols, regulatory submissions and various scientific and medical-related reports. * Must be able to prioritize multiple projects simultaneously. * Ability to facilitate & coordinate many types of study documents & submissions with various departments, agencies and offices. * Knowledge of clinical research trials process and regulations. * Word, Excel, Access, Publisher, Web access with ability to navigate to various institutional & governmental sites. * Blood Systems Inc. is an equal opportunity employer. EEO/Minorities/Females/Disabled/Veterans Our organization is an equal employment/affirmative action employer. If you need accommodation for any part of the employment process because of a medical condition or disability, please send an e-mail toaccommodation@bloodsystems.org or call 1-844-220-2612 to let us know the nature of your request. A representative will respond to accommodation requests within two business days. Please note that this email/phone number is for medical/disability accommodations only and any other inquiries will not receive a response. Please see the below information about applicant rights and our commitment to compliance: EEO is the Law EEO is the Law Supplement Pay Transparency e-Verify All candidates who receive a conditional written offer of employment will be required to undergo a pre-employment drug test in accordance with the Company's established guidelines. Bloodsystems Pittsburgh PA

Administrator, Regulatory Compliance

Expired Job

University Of Pittsburgh Medical Center