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Corporate Compliance Operations Lead

Date: Jun 14, 2022

Location: Remote, US

Company: Spark Therapeutics

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

 

 

Summary

 

The Corporate Compliance Operations Lead is primarily responsible for the analysis of global HCP and HCO spend data from internal and external sources to ensure compliance with applicable global, US federal and state reporting requirements and company policies. The incumbent in this role is also accountable for the development and execution of the annual healthcare compliance auditing and monitoring plan and mitigation/remediation activities.  S/he will provide additional compliance operations-related duties as described below.

 

Responsibilities

Aggregate Spend and Transparency analysis:

  • Analyze global HCP and HCO spend data from internal and external sources to ensure compliance with applicable global, US federal and state reporting requirements and company policies
  • Analyze and reconcile individual payments or transfers of value to HCPs and HCOs to confirm data is complete, accurate and consistent, including review of Concur, Accounts Payable and third-party vendor data
  • Manage the weekly remediation activities associated with payment data
  • Train internal teams and vendors (e.g., Research, Development, Medical Affairs, Patient Advocacy, Commercial, CROs, external agencies, etc.) on transparency requirements, data capture, and validation processes
  • Develop training content and review requirements both formally and informally with employees and third-party vendors
  • Support testing and implementation of Aggregate Spend enhancements to various systems (e.g., CRM, accounts payable, purchase order systems)
  • Support business teams with Compliance requirements related to engagement with HCPs and HCOs outside the US (OUS), including assistance with capture and verification of marketing and healthcare expenditures to ensure accurate, consistent, and timely reporting to OUS and US agencies
  • Monitor CMS and other external sources for the latest information regarding Global Transparency and Aggregate Spend reporting to government agencies
  • Develop improvements and new business rules to enhance data capture and accuracy and collaborate with Information Technology, third-parties and OUS business partners to resolve and improve data management and operational processes
  • Validate spend data with Spark business owners annually
  • Auditing and Monitoring:
  • Develop annual healthcare compliance auditing and monitoring plan
  • Executes ad hoc healthcare compliance audits and monitoring of functional processes and systems across Spark (e.g., field personnel activities, ad boards, speaker programs, IME, IIR, CRM, Concur, Aggregate Spend, Veeva, Outlook) to ensure adherence to Code of Conduct and Business Ethics, policies, guidelines, and SOPs
  • Develop auditing and monitoring metrics, and implement data analytics models and trending analyses, with limited oversight by management, to identify areas of risk and target monitoring activities
  • Use knowledge of compliance risks and understanding of database reporting capabilities to develop audit and monitoring strategies and plans
  • Collects, examines, and analyzes records, policies, operating practices, documentation, and transactions; prepares and presents audit reports; recommends opportunities to strengthen the internal control structure and assists with corrective action planning
  • Summarizes and communicates audit progress and findings to various levels of management, both live and in written materials
  • Collaborates with Corporate Compliance team members, Legal and cross-functional stakeholders in Commercial, Development, Medical Affairs, etc. on audit and monitoring findings, recommended corrective actions and/or risk mitigation activities
  • Conducts routine and ad hoc follow-up from previous auditing and monitoring activities to ensure corrective actions or other remedies have been sufficiently completed in a timely manner
  • Develops relationships with Spark personnel across functions and teams and provides coaching and compliance guidance as needed or otherwise appropriate Budget, Background Screening, Fair Market Value administration, and other Compliance miscellaneous projects:
  • Develop annual department budget, reconcile spend and submit quarterly accruals to Finance
  • Conduct background screening for HCP services to Spark
  • Advise internal stakeholders with FMV calculations related to HCP services
  • Ensure documents related to Transparency and Aggregate Spend and Interactions with HCPs/HCOs are current on our Spark Space
  • Corporate Compliance Policies and Procedures
  • Assist with drafting of policies and procedures with input from company-wide SMEs
  • Coordinate review and approval of policies through policy management system

 

Education and Experience Requirements

 

  • Bachelor's degree required
  • Professional certification preferred (i.e., CIA, CPA or Healthcare Compliance)
  • Graduate-level degree preferred (e.g., MBA or related discipline)
  • Generally, 5  years of experience in the Pharmaceutical, Device, or Biotech industry with a minimum of 2 years of compliance transparency, auditing, and monitoring experience
  • Generally, 2 or more years of previous experience effectively leading a program or project from inception to implementation
  • Demonstrated knowledge of gene therapy preferred
  • Ability to travel both domestically and internationally (30%)
  • This role is REMOTE

 

Key Skills, Abilities, and Competencies

 

  • Requires limited direction to complete standard work
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure timely, on target and within-budget accomplishment of such
  • Proven track record of effective decision-making; makes good business decisions and consistently exercises sound judgment. Applies sound judgment around escalation of issues.
  • Excellent written and verbal business communication and public speaking/presentation skills; highly adept at synthesizing and summarizing complex and/or voluminous content into clear, concise, and actionable communications.
  • Proven experience with creating analytical assessments and presentations.  Proficiency in Microsoft Office 365 and industry standard and proprietary software solutions (e.g., Veeva, Concur, etc.)
  • Ability to work in a dynamic, fast-paced environment with shifting priorities
  • Demonstrated knowledge of relevant laws, regulations and industry guidance that affect Spark’s Corporate Compliance Program (e.g., OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Providers, industry guidance documents, CIA trends, regulations regarding the investigational assets, promotion FDA-approved products, Open Payments EFPIA and the False Claims Act and Anti-Kickback Statutes).

 

Complexity and Problem Solving

The Corporate Compliance Operations Lead is responsible for the day-to-day management of Spark’s healthcare compliance transparency program.  S/he is also responsible for the development and execution of Spark’s annual healthcare compliance auditing and monitoring plan and mitigation activities. Disciplinary actions resulting from the output of auditing and monitoring will be made in collaboration with the Corporate Compliance Operations Leader, Employee Relations, and Spark’s Associate General Counsel for the People Organization. 

For the various miscellaneous operations-related responsibilities the incumbent with have the authority to make decisions with oversight from the Corporate Compliance Operations Leader.

Decisions related to the development of the annual departmental budget will be made with oversight from the Corporate Compliance Operations Leader and approved by the Head of Corporate Compliance. 

 

 

Internal and External Contacts

 

Internal:

•            Accountable to the Corporate Compliance Operations Leader

•            Corporate Compliance Leadership Team

•            Market Access,

•            Business Development

•            Marketing

•            Patient Services

•            Medical Affairs

•            Development

•            Research

•            Finance

•            IT

•            Legal

•            Human Resources

•            Spark People Managers

•            Genentech Corporate & Healthcare Compliance team members

•            Roche Group Audit & Risk Advisory

External:

•            Third-party Service Provider for transparency, auditing, monitoring and compliance operations support. 

#LI-JL1

 

 

 

 

 

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location.  Accommodations may be made in accordance with applicable law.


Nearest Major Market: Eugene