The Corporate Compliance Counsel provides compliance advice and guidance to the Corporate Compliance department and to Spark Therapeutics, Inc. (“Spark” or “the Company”) commercial business and certain corporate functions regarding the Company’s Code of Conduct and Business Ethics (“Code”), Corporate Compliance policies and standards, and other compliance issues and inquiries. The Corporate Compliance Counsel supports compliance with laws and regulatory requirements of local, state, and federal agencies, as well as Spark’s compliance policies and procedures. In collaboration with the Corporate Compliance team, this role establishes and implements the Corporate Compliance Program to ensure its effectiveness in promoting and enforcing the Code and compliance policies and procedures, as well as preventing, detecting, and correcting non-compliance with the Code, compliance policies and procedures, and applicable laws and regulations. This role advises and supports compliance investigations to ensure that such investigations are conducted in a timely, objective and comprehensive manner and appropriate corrective action is implemented in accordance with the Company’s compliance policies and procedures. The Corporate Compliance Counsel collaborates with key stakeholders across cross-functional business units to ensure that the Code and Corporate Compliance Program are implemented appropriately and enforced consistently. This role interacts with and advises Functional Heads and the Senior Leadership Team (“SLT”) on compliance matters that affect the success of the Company and the execution of the Company’s strategic business priorities. The Corporate Compliance Counsel, in collaboration with the Corporate Compliance team, develops, updates, and implements Corporate Compliance Program strategies, policies and procedures, oversight processes, and program controls. This role participates in the Corporate Compliance training program to deliver timely and targeted education to Spark business units. The Corporate Compliance Counsel monitors global legal, compliance, and regulatory matters throughout the pharmaceutical/biotech industry, as well as regulations and guidances of local, state, and federal agencies, to identify those issues, changes, and emerging risks that may affect the Company and to assist with implementing modifications, as needed, to the Corporate Compliance Program and/or Spark’s business operations.
% of Time Job Function and Description
35% Compliance Program Monitoring and Risk Mitigation
- Implement Spark’s Corporate Compliance Program. Ensure that compliance policies, procedures, and training are developed, adopted, published, and communicated to all employees, and other relevant stakeholder to prevent illegal, unethical, non-compliant and/or improper conduct.
- Maintain Corporate Compliance policies and procedures to ensure currency with emerging laws, regulations, and trends of local, state, and federal agencies and applicable changes relevant to legal and compliance risks throughout the pharmaceutical/biotech industry.
- Periodically review and update the Code to ensure continued relevance in providing guidance to employees, management, senior leadership, and external individuals and entities, and to deliver required training on the Code, as needed.
- Actively monitor regulatory agencies and the pharmaceutical/biotech industry for best practices, emerging trends, and potential risks in corporate compliance.
- Champion an ethical culture in which compliance and business objectives are mutually reinforcing and the Corporate Compliance Program is well integrated into the Company’s business activities.
- Partner with Functional Heads and members of the SLT to maintain and enhance a strong culture of compliance, including personal accountability at all levels in the organization, with a spirit of partnership and positive problem-solving.
- Evaluate issues and respond to inquiries regarding application of the Code and related policies and procedures. Advise and guide Functional Heads to resolve any related challenges.
- Partner with the Corporate Compliance Operations Leader regarding monitoring and auditing activities relative to the Code and compliance policies and procedures. Advise on appropriate corrective action in response to irregularities identified from compliance monitoring and auditing activities.
- Ensure that compliance issues or concerns are appropriately evaluated, investigated, and resolved, and any remediation is conducted using an effective and consistent system of discipline to address misconduct.
- Partner with the Corporate Compliance team and/or Legal to facilitate, track, and support, where appropriate, any investigations of potential non-compliance with the Code or the Corporate Compliance Program. As needed, assist with the implementation and ongoing monitoring of any corrective action.
- Assist the Head of Corporate Compliance by implementing periodic risk assessments, audits, and reporting procedures to identify potential areas of compliance vulnerability and risk. Implement preventative and corrective action plans to mitigate identified risks.
- Provide reports on a regular basis, and as directed or requested by the Head of Corporate Compliance, to inform management regarding the operation and progress of the Corporate Compliance Program.
30% Compliance Advisement to Legal, Business Units, and Senior Leadership
- Partner with, support, and advise cross-functional business units regarding the mitigation of risk assessment activities to optimally manage and avoid issues with compliance risk.
- Serve as the Corporate Compliance liaison to Functional Heads and cross-functional teams to address compliance inquiries and challenges, design and implement customized policies and procedures, and achieve business goals in compliance with relevant laws and regulations and Corporate Compliance policies and procedures.
- Provide compliance-related legal advice and insight to Functional Heads and cross-functional teams regarding various R&D and commercial initiatives. Participate as the Corporate Compliance representative on cross-functional teams to advise on the full spectrum of activities from concept proposal to final execution.
- Advise Functional Heads and cross-functional teams on general or specific compliance legal matters related to the Company’s business strategies and initiatives.
- Create, maintain, and evaluate appropriate reporting related to the Corporate Compliance Program. Develop and present, as needed, reports and presentations to Functional Heads and cross-functional teams.
- Support other compliance projects and initiatives, as requested, by the Head of Corporate Compliance to provide targeted solutions to Functional Heads and cross-functional teams.
- Advise, as needed, on compliance risk management initiatives (e.g., horizon-scanning for emerging risks).
- Provide, as needed, compliance counsel on general and specific health law and regulatory compliance matters.
- Partner with Legal, as requested, on activities related to various business transactions, corporate policies and procedures, and risk mitigation.
25% Corporate Compliance Policy Development, Monitoring, and Training
- Design and implement enhancements to the Corporate Compliance Program and promote awareness of, conduct training for, and ensure adherence to the Code and related policies, procedures, and guidelines.
- Develop, publish, maintain, and interpret compliance policies and procedures as may be appropriate to fully implement the provisions of the Code and related compliance policies and procedures and/or to meet the requirements of applicable statutes, regulations, and business standards.
- Collaborate with the Corporate Compliance team to develop new policies and training in response to changes concerning laws, regulations, and guidances that affect Corporate Compliance policies and procedures.
- Collaborate with the Corporate Compliance team to develop and revise, as needed, risk assessment plans and auditing and monitoring protocols.
- Monitor and present emerging trends in compliance training to the Corporate Compliance team to ensure that the compliance training program is dynamic and fully reflects leading practices for content development and delivery formats for compliance training.
- Partner with the Corporate Compliance Operations Leader to prepare and deliver compliance training to all employees to ensure understanding of and adherence to the Corporate Compliance Program and related compliance policies and procedures.
5% Compliance and Business Ethics Helpline
- Participate in investigations arising from reports submitted to the Compliance and Business Ethics Helpline regarding alleged violations related to the Code and Company policies or procedures.
- Advise and guide on any violations that require remediation, recommend appropriate corrective action, and participate in discussions with Functional Heads, Legal and/or HR to implement remediation plans. As needed, support ongoing monitoring to ensure full compliance with Company policies and procedures.
5% Communications to Senior Leadership and Board of Directors
Education and Experience Requirements
- Design, develop, and present reports and presentations to the cross- functional teams and SLT, CMT, and BOD or assist the Head of Corporate Compliance with these communications.
- Include educational requirements or equivalency, required years and type(s) or experience, and necessary licenses or certificates.
- Juris Doctor degree and bar admission to the state of Pennsylvania (member in good standing) or licensed in another US jurisdiction and qualified to hold a limited in-house counsel license in Pennsylvania
- Generally, 10 or more years of experience in the biotech/biopharma/pharma industry with pharmaceutical products intended for human use or with other life-science regulated industries. Strong experience in global healthcare compliance or legal department(s) with a demonstrated deep understanding of the complex functions of a pharmaceutical organization and the associated legal, regulatory, and compliance matters of the industry.
- 5 years or more of experience preferred with developing and monitoring a corporate compliance program and associated policies, procedures, and training; conducting and resolving internal investigations; and partnering effectively with cross-functional teams to advise on compliance matters and challenges.
- Deep and well-rounded knowledge of applicable federal, state, and local laws and regulations 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, Stark Law, HIPAA, regulations regarding the promotion of marketed products, EFPIA and the False Claims Act, and Anti-Kickback Statutes).
Complexity and Problem Solving
- Excellent organizational, advocacy and facilitation skills to effectively implement the Corporate Compliance Program and manage change, as needed, and to engage others to implement changed processes to ensure ongoing compliance with the Corporate Compliance Program
- Excellent written and verbal communication skills; excellent public speaking/presentation skills and experience with designing and presenting training materials
- Demonstrated ability to operate in an entrepreneurial, responsive, and collaborative style focused on advancing Spark’s business priorities while ensuring adherence to the Company’s compliance programs and projects
- Proven experience building and cultivating relationships with key partners and stakeholders across all organizational levels
- Strong ability to build credibility and communicate effectively with individuals and teams in Spark business units and to inspire confidence and support for compliance initiatives
- Strong collaboration, critical thinking and negotiation skills to influence cross-functional teams in problem resolution and to direct decisions toward desired outcomes (e.g., resolution of compliance investigations)
- Ability to resolve compliance challenges across the organization while demonstrating discretion, confidentiality, and respect for colleagues
- Proficient interviewing and interrogation skills that achieve effective outcomes while eliciting trust and demonstrating courtesy and respect
- Experience and confidence with counseling regarding compliance matters
- Impeccable ethics and proven abilities to reflect, support and promote Spark’s values
- Describe the decisions made by the incumbents on a regular basis. Include decisions within the Incumbent’s authority to make as well as those decisions that must be referred to a higher level.
- Ability to think critically, strategically and quickly analyze complex compliance circumstances and problems
- Demonstrated ability to synthesize information from diverse sources, develop options for resolution, make decisions that are rational and based on sound evidence, and determine an action plan, as needed
- Ability to oversee projects and successfully complete them in an organized, efficient, and effective manner
- Ability to provide compliance-related legally sound recommendations
- Proven ability to advise on complex compliance-related matters and communicate information concisely and effectively to cross-functional business teams
- Ability to work in a dynamic, fast-paced environment with shifting priorities and to interact successfully in a global company with a culturally diverse workforce