Regulatory Affairs Senior Compliance
Resume:
JEN L. BERRY
Contact: 850-***-****
Email: ad3hhc@r.postjobfree.com
PROFILE
Thorough, analytical, detailed-oriented, process driven, ambitious individual with cross-functional experiences and background to include investigation management and administrative rule interpretation; use rigorous logic and methods to solve difficult problems with effective resolutions; outstanding administrative and organizational skills, strong strategic thinking and planning skills, communication and negotiation abilities combined with a passion for respect and customer service; functions well in high pressure situations; accustomed to handling sensitive, confidential records with a talent for quickly mastering new technologies and processes.
SKILLS SUMMARY
- Investigation Management
- Operations Management
- Program Evaluation
- Certified OSHA Auditor
- Compliance Enforcement
- Records & Evidence Management
- Medical Terminology & Processes
- Employee Management
- Administrative Code Creation &
Interpretation
- Statute Evaluation & Interpretation
- Educating/Training
AWARDS
- Florida Department of Health, Child Care Food Program – Innovation (Project and Systems Development)
- Florida Department of Health, Medical Quality Assurance, Bureau of Enforcement - Leadership
- Florida Department of Health, Board of Medicine – 2021 Team Award PROFESSIONAL EXPERIENCE
January 2022 – Current
Henry Schein, Inc.
Remote
Regulatory Affairs Specialist
Recruited to implement systems and processes needed to ensure compliance for licensure, disciplinary and other reporting requirements; solely complete FDA, state, and Puerto Rico licensing applications for InSource, Inc.; assist with compliance and licensing applications for Henry Schein and other subsidiaries as needed.
Research and analyze applicable laws and regulations for the legal, DEA, licensure and subsidiary teams and provide administrative rule interpretation; develop and implement the necessary policies and procedures to ensure the company’s ongoing compliance with federal, state, and local requirements.
Conduct periodic internal regulatory and OSHA audits on facilities; assist in virtual DEA customer site audits to assess levels of compliance and risk; coordinate the implementation of systems and procedures to ensure compliance with OSHA regulations; provide support during government inspections and formulating the appropriate response and corrective actions.
Assist with compliance related DOT requirements for the classification, storage, and distribution of Hazardous Materials; as well as the activities to comply with environmental laws, including the registration and disposal of pesticides and other type of type of chemical products; support distribution centers management and designated staff on the actions necessary to maintain regulatory compliance.
Serve as the team project manager for the Corporate Brand Development Group and other business units researching issues pertaining to regulatory matters; secure and maintain proper company licensure and product registration as needed to support HSI Operations and Business Units; project manager for compliance of the Dental and Medical Private Brand Product Preview Program; participate in special projects and performs other duties as required.
Develop and provide appropriate awareness and training programs for team members consistent with regulatory compliance policies and procedures; Assist the RA team with transactional due diligence, and implementation of post-closing responses to issues identified in due diligence. April 2019 – January 2022
Florida Dept. of Health; Medical Quality Assurance, Bureau of Enforcement Tallahassee, FL
Headquarters Investigator Supervisor
Recruited and served as the state enforcement Headquarters Investigator Supervisor, assisting the Program Administrator and Bureau Chief in overseeing all state inspection and investigation programs for health boards under the agency; solely managed the planning, coordinating, and directing of operational activities for the Office Surgery Registration (OSR), Pain Management Clinic (PMC) and the Dental Sedation inspection and investigation programs, including all personnel and program aspects of staff supervision for the Registered Nurse and Dental Anesthesiologist Consultants (inspectors/investigators); drafted and maintained all budgetary plans and spending approvals for the ORS, PMC, and Dental Sedation programs and consultants.
Delegated and oversaw assignments for review and quality control of cases, evidence control, and other related cases. coordinated and collaborated with law enforcement officials at the local, state, and/or federal level on investigations, testimony for administrative hearings, and trials when required; assembled cases for legal review for non-complaint inspections and licensee complaints, prepared and oversaw disciplinary actions, complaints, and approved or denied performance improvement plans (CAPs).
Worked closely with all health board offices, General Council attorneys, and on occasions, state senators on statute and rule changes and creation to ensure public safety and enforcement capability; developed statistics and informational materials for the media, legislative committees, and other state and local groups; conducted research of statutes, rules, policy, procedures, and other data on critical issues, assists with the preparation of management reports.
Met with managers, inspectors, investigators, and agency attorneys on a regular basis to assess progress, provide guidance, rule interpretation, and assist in solving issues with inspections and investigations; interpreted laws, rules and regulations and advised subordinates on all policy and procedural changes; resolved operational and policy issues, monitored compliance with rules, regulations, and operating procedures.
Created and implemented new policies and procedures related to the Investigative Services Unit operations programs including, new initiatives related to the Division’s strategic priorities; conducted and assured training was completed on a regular basis in accordance with policy and procedure for all assigned personnel. October 2016 – April 2019
Florida Dept. of Health; Bureau of Child Care Food Program (CCFP) Tallahassee, FL
Policy & Compliance Operations Review Specialist II /Project Manager
Recruited and served as the Headquarters Fraud and Complaint Investigator for a federally funded program
(CCFP) though the USDA, investigating program regulated state and federal violations and oversaw the programs field investigators.
Coordinated and collaborated with law enforcement officials at the state, local or federal level on investigations, testimony for administrative hearings and trials, when required; prepared evidentiary findings for DOH General Counsel and USDA Inspector General to be reviewed for further criminal investigation; prepared disciplinary actions, complaints, and performance improvement plans; testified in administrative hearings.
Served as Policy Section backup for the Disaster Relief Application approvals and Renewal Process approvals for current contractors to ensure continual compliance with state and federal regulations; completed Disaster Relief Application Process approvals to ensure applicants meet both state and federal requirements to receive funds.
Applied data system technology and analytics to assist in the operational analysis of performance and enforcement of Policy and Compliance program requirements; provided support in system trouble shooting, technical assistance, training, and guidance to CCFP staff and contractors; developed statewide trainings and processes and ensured all assigned inspectors completed mandatory trainings.
Developed and served as the Project Manager for the Contractor Activity Tracking System (CATS), providing a complete view of the contractor’s activity during the application, complaint, serious deficiency, and termination process to ensure both federal and state regulation standards are met and providing measurement of CCFP employment performance standards.
Served as the project manager and contractor liaison for the development of an online review tool to automate the field staff’s compliance reviews; collaborated with other federal and state agencies on technology enhancements, including presentations on advancing integrity through technology at national conferences. May 2012 – October 2016
University Collision/Quality Wrecker Service
Tallahassee, FL
Collision Center/Wrecker Service Manager
Recruited to manage all law enforcement contracts, workload, and storage facility; served as the liaison for accident investigations including protection of evidence to remain untampered and held in compliance with state and local laws and procedures.
Wrote automotive estimates meeting state insurance and OSHA regulation standards; ordered and checked in all parts required for repairs; completed returns for parts when necessary; assisted insurance company adjusters with estimate reconciliations to ensure state and federal requirements for repairs are met; managed scheduling associates, service appointments, and organized day to day activities to increase productivity and deliver quality work on time to customers; created and set quality controls.
Completed biweekly payrolls for all employees and monthly accounts receivable and payables; created and conducted trainings; completed all human resource duties.
Provide all the above duties for owners' secondary company, Quality Wrecker Service, ensuring compliance for all law enforcement audits and state standards.
December 2008 – May 2012
ITT Technical Institute
Tallahassee, FL
Executive Marketing Assistant
Served as the assistant to the Director of Marketing for the Tallahassee campus; prepare reports for the Regional Manager; provided support for the dean, lead instructors and adjunct instructors.
Created and coordinated schedules for the marketing department; assisted the marketing team by preparing reports, checklist, forms, correspondence as well as inventory of marketing materials; input student leads via Student Fast Entry and assign to the marketing specialist based on tier status; coordinated the interviewing process for perspective marketing team members and instructors.
Provided training, guidance and professional development for the administrative staff and marketing team; assisted company by filling in for administrative assistant, completing accounts payable tasks and reports to send to HQ.
Received and investigated student complaints; created and implemented Corrective Action Plans; reviewed progress to determine if/when further action was required. January 2006 - December 2008
Tallahassee Community College
Tallahassee, FL
Staff Assistant to the Dean of English/Humanities
Complete administrative support duties and functions for the Dean and the Assistant Dean.
Received and investigated Student Complaints and processed accordingly.
Coordinated interviews for Professors and Adjunct Instructors.
Received student requests for class assignment and assigned to instructors based on availability.
Maintained LAN applications, and mainframe access.
Coordinated assignments for office staff.
Composed correspondence and draft documents for review. January 2002 - December 2005
Florida Dept. of Education; Vocational Rehabilitation Tallahassee, FL
Administrative Secretary/Vocational Rehabilitation Technician
Reviewed and audited administrative actions regarding authorizations and contracts, travel/training reimbursements, personal actions, personnel requisitions, leave and attendance records and other documents required by state/federal law.
Assisted supervisor with implementing and providing efficient use of financial resources.
Traced unit budget, ordered supplies, scheduled supplies, prepared, and processed authorizations required for employment for individuals with disabilities.
Scheduled interviews, prepared personnel packets, checked packets and compiled recommendation packets.
Assisted VR certified counselors in providing services to eligible individuals with mental/physical/emotional disabilities.
Worked directly with clients to obtain referral information, made referral appointments, assisted VR counselors with interviews and completed the application process.
Acquired additional information needed including vocational, psychological, medical information, CPT codes and signed authorizations from physicians.
Processed physician bills for payment, scheduled IEP appointments for clients and assisted with transportation when needed.
Maintained ongoing contact with clients, research clients where contact had been lost, communicated needs to community, vendors, and staff.
Assisted counselors with job placements and follow-up services, benefits, and processed expenditures in accordance with state and federal regulations and polices.
Documented activities in client case records.
January 1999 - January 2002
Leon County Schools; Exceptional Student Education/Early Childhood Programs Tallahassee, FL
Secretary II
Maintained the new Federal Database, Children’s Registry, and Information System (CRIS), for Leon County Early Childhood Program for children ages birth to 5 years of age; Responsible for 1/3 of Leon County Schools data entry for Individual Education Plans and Family Support Plans for Pre-K through 12th grade.
Completed intake referrals, scheduled all screening and evaluation appointments, and completed the Medicaid process for clients.
Responsible for the operations side of the Lively Early Education and Care Center including, but not limited to, maintaining the federal food grant, enrolling all students, A/R and maintaining all licensing and re-licensing procedures.
Assisted in preparation of evidence for due process hearings and assisted and assisted in LCS administration meetings.
Professional and Personal References
Professional References
Misty Touchette, Regulatory Projects Manager; Henry Schein, Inc. Name as known to reference: Jen L. Berry
Liam Schauer, DEA Compliance Manager; Henry Schein, Inc. (Former MQA Enforcement Manager) Name as known to reference: Jen L. Berry
Crystal Sandford, Program Administrator (RET); Florida Department of Health, Board of Medicine Name as known to reference: Jen L. Berry
Brenda Lane. Manager (RET); Florida Department of health, Childcare Food Program Name as known to reference: Jen L. Berry
Stan Freeman, Owner; University Collision Center; Quality Wrecker and Tow Name as known to reference: Jen “Shellahamer” Berry
Adam Briggs, Former Associate Dean; ITT Technical Institute Name as known to reference: Jen Shellahamer
Paul Haigh, Former Director of Recruitment; ITT Technical Institute Name as known to reference: Jen Shellahamer
Personal References (Others available upon request) Nancy Taylor; Mount Sinai Hospital; IT Applications Specialist Name as known to reference: Jen Berry
Years known: 8
Cindy Dick; Former FDOH Chief of Staff; Former Chief of the Tallahassee Fire Department Name as known to reference: Jen “Butler” Berry
Years known: 35
Captain Judi Davison; Tallahassee Fire Department
Name as known to reference: Jen “Butler” Berry
Years known: 35
Lieutenant Ken Davis (RET); Tallahassee Fire Department Name as known to reference: Jen “Butler” Berry
Years known: 35
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