Corporate Compliance Operations Lead
Job Opportunity at Spark Therapeutics, Inc

Posted on Jan 2

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

Location: Philadelphia, PA
Job Type: Full Time
Job ID: W4149166

The Corporate Compliance Operations Lead role is responsible for the development, management, execution and delivery of key Corporate Compliance programs including, but not limited to:
  • 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

LMS Management
  • Responsible for development, management, execution and delivery of the Corporate Compliance Learning Management System (“LMS”) 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

Aggregate Spend
  • Co-Lead Spark’s Aggregate Spend program
  • 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

Policy, Training and Communications
  • 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

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
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

Fair Market Value (FMV) Administration
  • Provide FMV rates to internal stakeholders related to HCP services
  • Conduct bi-annual review of FMV rates for accuracy
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
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
  • 8 – 10 years of 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
  • Working knowledge of, or ability to quickly become conversant with, various 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 promotion of marketed products, EFPIA and the False Claims Act and Anti-Kickback Statutes)

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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