Technical Editor //MA

Location: Lexington, MA
Date Posted: 09-21-2017
Technical Editor
12 months
Lexington MA
  • Under the direction of Compliance Department CIA team leadership, this position will implement operational aspects of the Corporate Integrity Agreement, primarily consisting of CIA Covered Person identification and tracking, support to Independent Review Organization (IRO) activities, assistance in preparation of the CIA Annual Report, and other duties as assigned.
  • The Compliance Specialist will help the organization ensure training of employees, and tracking of training status, by:
  • leading the management of daily HR data feeds from HR systems to assign Covered Person status to employees, contractors, and vendors;
  • reconciling HR, Covered Persons and Learning Management Systems databases to ensure required training is assigned appropriately; and
  • Monitoring changes to source systems to assess and manage downstream impacts on processes.
  • Other duties include performing Ineligibility screening of Covered Persons against federal exclusion lists, organizing and developing content for the annual CIA report submission to the OIG, and maintaining CIA documentation in SharePoint.
  • The Compliance Specialist will be expected to engage in real-time troubleshooting and problem solving to achieve duties and, where possible, identify process improvements to improve efficiency and effectiveness.
  • The role also requires close coordination with the Compliance Operations Training department and frequent communications with internal and external personnel across various levels and functions of the organization.
  • % of Time Job Duty and Description
  • 70% Perform identification and tracking of Covered Persons (CPs) in accordance with Shires Corporate Integrity Agreement requirements. Maintain electronic CP tool to ensure accurate assignment of the organizational levels to CIA Covered Functions. Update CP database as needed to reflect staff and management changes.
  • 20% Support CIA Annual Report preparation, including content development and report production
  • 10% Facilitate projects as assigned for CIA operational effectiveness and process improvement, including support to IRO reviews.
Education and Experience Requirements
  • Bachelors degree from an accredited institution
  • Experience working in the pharmaceutical/biotechnology industry with a good understanding of the regulatory and business environment, including sales, marketing, and medical functions
  • At least three years of project management experience, with a significant portion of that experience involving Compliance program operations
  • Previous experience operating under a Corporate Integrity Agreement desired
  • Key Skills, Abilities, and Competencies
  • Excellent project management skills and ability to manage multiple tasks and assignments simultaneously
  • Effective interpersonal and communications skills demonstrating a flexible, collaborative and team oriented approach to problem-solving
  • Ability to operate independently and work in a fast-paced, rapidly changing environment
  • Attention to detail and well-developed organizational skills
  • Ability to analyze data to identify gaps, trends and areas of focus or improvement
  • Proficiency with MS Office tools
  • Complexity and Problem Solving
  • Management of ongoing day-to-day operational assignments
  • Application of business rules to determine Covered Person status
  • Interface with Human Resources Operations and IT staff to resolve HR data issues and appropriate escalation to Compliance CIA team leader as needed
  • Internal and External Contacts
  • The position will interact with Global Compliance staff at all levels as well as other Shire functions including Legal, IT, Human Resources, and Business Unit employee
Key Business Solutions, Inc.
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