Title: Director of Compliance Operations
Reports to: Chief Compliance Officer
General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a highly visible role that is responsible for leading the Compliance Department's activities with respect to process design, project management, vendor management, field-force monitoring and data analytics. The Director of Compliance Operations will be responsible for the design, implementation, oversight, and enforcement of business rules to enable compliance with relevant laws, regulations, and industry standards.
This senior professional will work under the supervision of the Chief Compliance Officer and in partnership with other senior leaders to advance SAGE’s Core Values and Compliance principles through the following:
Roles and Responsibilities
- Lead assigned projects related to process improvement and compliance monitoring.
- Translate policy standards into easy-to-use Work Instructions and business rules to guide execution of common activities, including technology-enabled workflows.
- Plan, develop, and roll-out trainings and other materials that increase awareness of Core Values and Compliance principles across the entire enterprise and that instruct specific employees how to carry out their roles and responsibilities in a compliant manner.
- Design plans and protocols for monitoring business activities to verify adherence to Compliance requirements, including sample selection of field-based activities and analysis of related documentation. Manage all aspects of monitoring program from plan development to participation in field rides and promotional program assessments.
- Collaborate with finance, IT, commercial operations, and other functional leads to leverage existing systems to inform Compliance objectives and to embed Compliance requirements in business processes.
- Analyze multi-source data (e.g., from monitoring, spend/transparency, sales and commercial operations) to identify Compliance-relevant risks and trends. Recommend corrective actions and process improvements to mitigate risks and enhance operations.
- Identify, negotiate with, and manage third parties, as appropriate, to support Compliance operations in alignment with strategic objectives and risk priorities.
- Communicate long term vision and goals to program participants and leadership
- Remove potential or existing barriers to execution of requirements
- Facilitate global, cross-initiative communication, prioritization, governance and /or alignment
- Maintain efficient cost planning and ensure the scope is executed within outlined and approved budget, optimizing wherever possible
- Manage Resources, direct and indirect; Identify resource bottlenecks, unique requirements, contingencies and define plans accordingly
- Provide proactive compliance business partner support to designated business areas.
- Independently serve as a strategic business partner who provides proactive compliance support to designated business areas, such as Sales, Marketing, Managed Markets, Patient Support, Commercial Operations and Medical Affairs.
- Contribute to the budget planning process by developing plans to support compliance business strategy, financials and organizational structure
- Develop, manage, and refine compliance strategy, policies, and processes to ensure company conduct is in accordance with global regulatory requirements, industry guidance, and best practices
- Establish standards and implement procedures to ensure that the compliance programs throughout the organization are effective and efficient in identifying, preventing, detecting, and correcting noncompliance with applicable rules and regulations
- Lead initiatives to identify and address challenges and/or compliance issues in the cross-functional environment through compliance related investigations and fact-finding activities
- Lead process improvement initiatives for any identified risk areas
- Lead the review and provide recommended updates to policies, standard operating procedures and controls
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- Four Year Degree, additional education a plus
- 7+ years of experience in an operational role, a substantial portion compliance-related.
- Experience in the biotech/pharmaceutical industry
- Demonstrated ability leading cross-cultural, cross functional, high-performance teams;
- Maintain a high degree of interest in professional development; attend relevant compliance training sessions and conferences and maintain ongoing professional credentials.
- Expertise analyzing multiple data sets, and ability to work from incomplete or non-exhaustive data, required
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Possesses strong written and verbal communication skills.
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
- Excitement about the vision and mission of Sage