Corporate Compliance Operations Lead
Job Opportunity at Spark Therapeutics, Inc

Posted on Mar 13

http://www.sparktx.com    215-220-9300

Location: Philadelphia, PA
Job Type: Full Time
Job ID: W4154786

This role is responsible for the development, implementation and management of key Corporate Compliance programs including, but not limited to:
  • Create and execute on Auditing and Monitor plan for all Commercial, Medical and R&D/Clinical activity.  Provide data analysis to business units to assess value and effectiveness of programs consistent with corporate objectives and compliance guidance.
  • Learning Management System (“LMS”) for training employees on Corporate policies and Standard Operating Procedures
  • Policy, training, and communications
  • Aggregate Spend related to interactions with Healthcare Professionals (“HCPs”) and Healthcare Organizations (“HCOs”)
  • Ad Board and Consultancy Assessments
  • Fair Market Value (“FMV”) administration when engaging HCPs in fee-for-service arrangements or engaging vendors/professionals in healthcare-related activities
  • Background screening of HCP consultants
  • Compliance & Business Ethics Helpline
  • Development of presentations to Senior Management and Board of Directors (“BODs”)

25%   Auditing and Monitoring
  • Create Compliance Monitoring strategy for overall Compliance Monitoring Plan for Commercial, Medical and Clinical R&D
  • Develop and execute Compliance Monitoring plan for all areas.
  • Analyze, document and report monitoring trends and metrics
  • Monitor Field Commercial, Patient Services and Medical activities and communications
  • Conduct data analytics and key trending analysis on data sets in order to identify areas of risk/ individuals to target for monitoring
  • Monitor disease awareness and promotional speakers program
  • Monitor Advisory Boards
  • Audit Field HCP Interactions Database
  • Audit T&E
  • Audit compliance with Company policies
15%   LMS Management
  • Responsible for development, management, execution and delivery of the Corporate Compliance Learning Management System the overall system administration including system performance and availability, vendor management, user assignment and maintenance, curricula, training materials, security, user support and change management
  • Provide functional and technical support, identify and troubleshoot system problems.  Ensure data integrity, testing of system changes and process improvement opportunities
  • Ensure data integrity including quality, accuracy, security, and usability of employee data and related interfaces by implementing adequate processes, controls and backup systems
  • Lead, in collaboration with vendor and internal stakeholders and business partners, the review, planning, testing and implementing system upgrades or patches
  • Design, develop, and deliver Corporate Compliance training materials, system documentation and end-user communications
  • Analyze and synthesize business requirements by interviewing business partners, conducting workshops and building relationships with stakeholders
  • Develop strategy for system needs and facilitate the creation and execution of business requirements, detailed functional specifications, process flows, use cases and proof-of-concept
  • Develop, implement and maintain, user procedures, guidelines and business processes documentation
  • Define and uphold standards regarding curriculum content, format and approval processes, including metrics
  • Lead annual (comprehensive) review curricula
15%   Aggregate Spend
  • Lead Spark’s Aggregate Spend program
  • Develop Aggregate Spend strategy and timeline for company including enhancements and maintenance of Aggregate Spend business assumptions.
  • Manage Aggregate Spend vendor on projects and programs related to Aggregate Spend and Global Transparency associated with HCP and HCO interactions, marketing and advertising payment information, grants and charitable contributions, clinical studies and R&D payments
  • Responsible for overall management of the aggregate spend system, including identifying new business rules and collaborating with IT and vendors to resolve data and operational issues, etc.
  • Analyze data feeds of HCP spend data from internal and external sources, communicate issues/findings to business partners and lead remediation activities
  • Act as a subject matter expert to key stakeholders, business partners and the Compliance Team
  • Conduct analysis and reconciliation of individual payments or transfers of value to HCPs and HCO to confirm data is complete, accurate and consistent
  • Lead activities to ensure the accuracy and timeliness of all federal and state spend filings
  • Develop policy, procedures and work instructions and train internal stakeholders on same for Aggregate Spend processes
  • Monitor CMS and other information sources for latest information regarding aggregate spend at both federal and state levels
  • Conduct data analytics and trending analysis on Aggregate Spend data to determine Compliance risk areas and findings.
  • Develop data analytics and key trending analysis on Aggregate Spend data to share with functional areas for assistance in their ongoing business and compliance efforts, as allowable by compliance/legal parameters
15%   Policy, Training and Communications
  • Develop overall strategy and timeline for company annual Corporate Compliance training plan.
  • Lead the annual development, implementation and maintenance of enterprise training and certification records for the Code of Conduct and Business Ethics and all Corporate Compliance training programs
  • Develop and implement the annual training plan for the Corporate Compliance Department
  • Develop, maintain and deliver training for compliance policies, procedures and work instructions
  • Track and measure employee training on all compliance policies, in accordance with Company policy, applicable laws, regulations and industry codes
  • Analyze, design, develop, training solutions, including interactive instructor-led courses, self-instruction, web-based learning and job aids
  • Develop and communicate messages in accordance with the Corporate Compliance Communication strategy
10%   Ad Board and Consultancy Assessment
  • Review and approve proposals from internal stakeholders and business partners for Ad Boards and Consultancy arrangements to ensure compliance with Company policies
5%     Compliance and Business Ethics Helpline
  • Update the web-based portal for the Compliance and Business Ethics Helpline with alleged violations and outcomes related to the Code of Conduct and Spark policies or procedures 
  • Prepare and present reports, dashboards and analytics to Corporate Compliance and Legal Management Teams regarding Spark’s compliance reporting and investigations outcomes
5%     Fair Market Value (FMV) Administration
  • Provide FMV rates to internal stakeholders related to HCP services
  • Conduct bi-annual review of FMV rates for accuracy
5%     Background screening of HCP consultants
  • Manage third-party vendor conducting background screening for HCP services to Spark to ensure that Spark does not employ or conduct business with individuals who, or entities that, are excluded from federal programs, individuals who are debarred or those who have been sanctioned by a state agency or licensing board or equivalent entity outside the United States
5%     Senior Management and BOD Reports
  • Develop reports and presentations to Spark’s Senior Management Team and BODs for Legal Counsel and Compliance Officer

  • Excellent written and verbal communication skills; excellent public speaking/presentation skills and experience with creating training materials in Microsoft PowerPoint® or other presentation formats
  • Broad knowledge of building, implementing and maintaining an LMS
  • Demonstrated experience in development and execution of high profile initiatives. 
  • Demonstrated analytical and problem-solving skills
  • Ability to lead and influence cross-functional teams
  • Ability to work in a dynamic, fast-paced environment with shifting priorities

  • Bachelor’s Degree in related field preferred (e.g., instructional design, educational technology, human resources)
  • PMP Certification preferred
  • Healthcare Compliance Certification preferred
  • Generally has a minimum of 10 years of relevant experience in the biotech/biopharma/pharma industry with pharmaceutical products intended for human use or with other life-science regulated industries
  • 5+ years working in progressively responsible positions building an LMS, and delivering and designing Corporate Compliance training programs or programs involving development of people in their professional roles
  • Experience with aggregate spend tracking systems, reporting requirements and analytics

Transforming Patient’s Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.

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