regulatory affairs specialist resume example with 13+ years of experience

Jessica Claire
  • Montgomery Street, San Francisco, CA 94105 609 Johnson Ave., 49204, Tulsa, OK
  • Home: (555) 432-1000
  • Cell:
Professional Summary
Over 16 years' experience in Healthcare Industry working with major acute care hospital, Homecare and Insurance Companies. Summary of Qualifications Medical Staff Physician Credentials Credentialing Specialist/Provider Enrollment Risk Base and Manage Care Experience in analyzing and developing strategies for regulatory submissions and compliance issues SharePoint Regulatory, Compliance, Quality Critical Thinking Medical Device Manufacturer/Distributor Registration High level of interpersonal, problem solving, and analytical skills Insurance Knowledge Managed care, Medicaid, Medicare, Private Insurance Credentials Databases Supports key operational strategic initiatives with a focus on credentialing or process improvements
Education and Training
Master of Business Administration: Healthcare Management, Expected in 2009
Indiana Wesleyan University - Marion, Indiana
Healthcare Management
Master of Health Administration: , Expected in 2011
University of Phoenix - , Arizona
Skill Highlights
Microsoft Office, Excel, Access, IDX systems, , SMS, Cerner, Physician Information Management, Morrissey/MSOW, Citrix, Symed, CAQH, AMISYS, Portico, Emptoris
Professional Experience
Regulatory Affairs Specialist, 05/2015 to Present
Abbott Laboratories, ,
  • Process license for out of state medical device manufacturers/distributor to State Boards of Pharmacy registration.
  • Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy Timely compile materials for license renewals, updates and registrations Maintain regulatory files/database and chronologies in good order.
  • Establish and maintain system for tracking changes in documents submitted to agencies or partners Experience /Knowledge of US regulatory requirements for legend drugs and manufacturer distributor Medical Devices Write and update standard operating procedures, work instructions, or policies.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards Develops documents and maintains process maps for assigned process Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review Monitors and tracks performance and compliance to standards for assigned processes.
  • Centene/Healthcare Support Temporary.
Contract Coordinator, 01/2015 to 05/2015
, ,
  • Assist with the contract submission process and the auditing of provider information systems (AMISYS) for consistency and best practices in Provider set up.
  • Maintain spreadsheets and collect, track, prepare, compile, and distribute statistical data for daily and monthly reports.
  • Maintain and report on the Health Plan(s) compliance with contract submission rules and exception requests and communicate to Manager on a monthly basis.
  • Support the contract submission process to ensure confirmation with Corporate standards by the Health Plan(s), provide support to the Contract Case Conferences and ensure that appropriate internal controls are established to account for and secure hardcopy or scanned images of contracts.
  • Develop and maintain current regulatory knowledge and keeps abreast of regulatory procedures and changes.
  • Coordinate the Corporate-wide data verification process for contracted providers.
  • Update contract organization's databases, as necessary.
  • Interface with the credentialing staff to ensure all Health Plan data systems are congruent.
  • Franciscan Alliance/Office Team Temporary.
Credentials Specialist/Provider Enrollment, 11/2014 to 01/2015
, ,
  • Responsible for processing of provider payor applications, initial, re-applications and attestations Filled out applications for practitioners and submit to Medicaid, Medicare and Anthem MDWise-FIC/CIR Region Anthem - Telestroke Medicare -855B Humana Responsible to complete and disseminate to health plans requested provider data Understands Medicare, Medicaid and commercial payor application process and EDI agreements Ensure all Provider Relations operations comply with State contractual requirements.
  • Credentialing of new physicians with hospitals and managed care plans Understands Medicare, Medicaid and commercial payor application process and EDI agreements Credentialing of new physicians with hospitals and managed care plans Re-credentialing established physicians with hospitals and managed care plans through CAQH Load payer id's on payer grid Track process of credentials enrollment in SyMed system and process terminations.
Credentialing Specialist/Coordinator, 10/2007 to 07/2014
Sax Arts & Crafts, ,
  • Analyze critical processes for review of initials appointment and reappointments Review and provide input into the Credentialing Committee Evaluate if clinical privileges request are based on education, relevant training, experience, and demonstrates current competence, including medical/clinical knowledge, technical and clinical skills Serves as the key liaison and support to Medical Staff officers and leaders to ensures compliance with credentialing and regulatory policies and monitors all expirable data to ensure compliance Acknowledged as a professional leader who understands quality, clinical care, education and research Monitor compliance with Accreditation Standards, Policies and Procedures, Medical Staff Bylaws, The Joint Commission, NCQA, HFAP, URAC, AAAHC, Federal/State laws and regulations Experience analyzing and evaluating department systems and operations Experience performing counseling, data collection, coordination and credential procedural related to provide work related to medical evaluation board processing and experience conducting briefings or training Advanced knowledge of Medical Staff discipline and general understanding of other Medical Staff disciplines.
  • Experience initiating and leading Medical Staff projects and ability to work with senior managers in business units.
  • Strong Medical Staff experience leading investigations and making recommendations to the Credentials Committee members Strong verbal communication skills and an ability to develop and Medical Staff relationships Lead trainer for new hires Lead project trainer for the department regarding internal processes.
auditing, Benefits, Billing, Citrix, Conferences, contracts, counseling, data collection, databases, database, Documentation, EDI, Homecare, information systems, materials, Access, Excel, Microsoft Office, Office, Monitors, clinical care, Policies, processes, Project management, quality, researching, research, SMS, spreadsheets, strategy, trainer, verbal communication skills

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Resume Overview

School Attended

  • Indiana Wesleyan University
  • University of Phoenix

Job Titles Held:

  • Regulatory Affairs Specialist
  • Contract Coordinator
  • Credentials Specialist/Provider Enrollment
  • Credentialing Specialist/Coordinator


  • Master of Business Administration
  • Master of Health Administration

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