Michael Ushry
DURHAM,NC
Summary
Forward-thinking Operations Specialist bringing 12 years of expertise in the Compliance sector businesses. Critical thinker cultivates rapport with individuals to optimize project goals and output, resolve complex problems and deliver innovative improvement strategies. Critical thinker cultivates rapport with individuals to optimize project goals and output, resolve complex problems and deliver innovative improvement strategies. Rational Operations Specialist with over 20 years of experience in the Compliance field. Thorough knowledge of supply chain management, logistics and forecasting.
Overview
20
20
years of professional experience
Work History
Operations Specialist II
IQVIA
Durham, NC
01.2021 - Current
- Supported diverse areas of regulatory responsibility by distribution to applicable destinations
- .Responsible for regulatory reportability assessment
based on standards provided. - Provide data in industry standard format for onwards reporting to the Regulators/Ethics Committee in order to fulfill expedited and periodic regulatory reporting requirements
- Assist with the distribution of Lifecycle Safety data to investigators, marketing authorization holders, customers and regulators. May coordinate, schedule and submit reports to regulatory authorities in accordance with established deadlines.
- Assist with administrative team support e.g. project start-up tasks’ creation and maintenance of project files, periodic distribution of AE listings; and shipping information supplies to sites.
- Coordinate team/department/customer meetings.
- Promote understanding of work instructions for use of all relevant electronic systems and maintenance of records.
- Oversee intake of cases and archiving process when multiple coordinators are involved.
- • Performs work in accordance with governing SOPs; work instructions and regulatory requirements.
- Assist in processing incoming and outgoing Lifecycle Safety data and reports i.e. collecting and tracking incoming Adverse Event (AE) and endpoint reports.
- Assist with entering data into Lifecycle Safety databases, submitting event data to Operational Team members, tracking submission, and assume workflow responsibilities for assigned projects.
- Prepare documents, files for meetings and committees where required i.e. endpoint duplication/dossier compilation oversight committees; and any other project related meetings.
- Create, track and archive case folders and project files across Lifecycle Safety service lines. File, retrieve and deliver case folders; assist in maintenance of document control room where required and support relevant applications/systems as directed by Operations Team member.
- Perform other duties as assigned.
Operations Specialist I
IQVIA
DURHAM, NC
12.2016 - 01.2021
- Organized and maintained all files related to regulatory actions.
- Monitored regulatory change required by new and revised laws and regulations, communicating complex protocols and determining operational impacts.
- Responsible for regulatory reportability assessment
- Provide data in industry standard format for onwards reporting to the Regulators/Ethics Committee in order to fulfill expedited and periodic regulatory reporting requirements e.g. CIOMS 1, MedWatch, CIOMS IV Line Listing,
- Submit Alert Letters (AL) to the Investigators
Operations Coordinator I
Quintiles
Durham, NC
04.2010 - 12.2016
- Managed daily functions of deskside support, including defining and implementing processes.
- Assist in processing incoming and outgoing Lifecycle Safety data and reports i.e. collecting and tracking incoming Adverse Event (AE) and endpoint reports; determining initial/update status of incoming events; and tracking timelines for completion of events. As required, assist with entering data into Lifecycle Safety databases, submitting event data to Operational Team members, tracking submission, and assume workflow responsibilities for assigned projects.
- Prepare documents, files for meetings and committees where required i.e. endpoint duplication/dossier compilation oversight committees; and any other project related meetings.
- Co-ordinate and check incoming documents from sites; review with checklist; ensure documents meets requirements in advance of further level review in conjunction operations team member.
- Create, track and archive case folders and project files across Lifecycle Safety service lines. File, retrieve and deliver case folders; assist in maintenance of document control room where required and support relevant applications/systems as directed by Operations Team member.
- Assist with the distribution of Lifecycle Safety data to investigators, marketing authorization holders, customers and regulators.
- Coordinate, schedule and submit reports to regulatory authorities in accordance with established deadlines. Assist with investigator mailings by creating labels using investigator lists, copying documents, stuffing envelopes, dispatching data using courier services and tracking and filing submitted materials.
- Document completion tasks under guidance from Operations Team member.
- Assist with administrative team support e.g. project start-up tasks’ creation and maintenance of project files, periodic distribution of AE listings; and shipping information supplies to sites.
- Identify and report to senior team member any issues with tracking, document and process-related systems, including problems with incoming faxes.
- Oversee intake of cases and archiving process when multiple coordinators are involved.
- Collaborate with operations and other functional groups to help achieve business goals.
- Involvement and contribution in local department committees e.g. Engagement, Admin, Quality initiatives.
- Performs work in accordance with governing SOPs; work instructions and regulatory requirements.
- Perform other duties as assigned.
Compliance Officer
Professional Recovery Consultants, Inc.-
Durham, NC
07.2003 - 01.2010
- Maintained and revised policy procedures for general operation of compliance program.
- Maintain state licenses, records, federal and state regulations.
- Train employees on FDCPA, FCRA, HIPAA, GLBA, state responsibilities, Code of Ethics and general compliance issues.
- Maintained dunning letter efficiency.
- Liaison with attorneys regarding legal issues facing the company.
- Conduct internal audits on compliance concerns.
- Conduct self explanatory deviation meetings and maintain accompanying logs.
- Support sales reps with new or potential clients to determine statutory needs for compliance.
- Quickly and effectively solve customer complaints (regulatory and informal).
- Maintain quality control/satisfaction records, constantly seeking new ways to improve company performance
Education
Some College (No Degree) - Art And Mass Communication
University of North Carolina At Asheville
Asheville, NCSkills
- Improvement Plan Knowledge
- Program Evaluation
- Experience in Leadership
- Content Management Expertise
- Quantitative Skills
- Planning and Coordination
- Human Relations
- Case Management
- Inventory Coordination
- Project Planning
- Staff Supervision
- Active Listening
- Training & Development
- Relationship Building
- Supervision & Leadership
- Problem Resolution
- People Skills
- Good Work Ethic
Timeline
Operations Specialist II
IQVIA
01.2021 - Current
Operations Specialist I
IQVIA
12.2016 - 01.2021
Operations Coordinator I
Quintiles
04.2010 - 12.2016
Compliance Officer
Professional Recovery Consultants, Inc.-
07.2003 - 01.2010
Some College (No Degree) - Art And Mass Communication
University of North Carolina At Asheville