Senior Director, Compliance
- Remote, Remote, Home Office, United States
- Employees can work remotely
- Department: Legal & Compliance
Aurinia exists to make a difference. From the earliest days of the company, we’ve seen the potential in applying a creative, thoughtful and responsible approach to developing and commercializing therapies with a goal of changing the course for patients in disease areas that have been historically challenging to address. We Care, for our patients and our employees.
We are currently commercializing a treatment of lupus nephritis (LN) in the United States and preparing for potential commercialization of this compound in the EU, UK, Russia and Japan with Otsuka Pharmaceutical. We are also looking to leverage our internal capabilities to advance additional innovative therapies which have the potential to change the lives of people with rare autoimmune and inflammatory diseases.
Aurinia is seeking a highly motivated Senior Director, Compliance to support a newly growing commercial business. They will assist with the implementation and management of the company’s overall compliance program consistent with executive management’s commitment to maintain a high standard of compliance. The Senior Director, Compliance supports the Chief Compliance Officer in the maintenance of a strong regulatory relationship and an effective complaint management program through timely and complete responses to regulatory requests.
- Work with the Chief Compliance Officer (CCO) to define and provide strategic direction for the Compliance function across all compliance program elements leveraging knowledge of industry best practices in compliance and risk-based mentality.
- Work with the CCO and business stakeholders to prepare compliance work plan based upon a compliance risk assessment.
- Proactively plan for emerging trends in compliance, anticipate the impact on processes, and work with business stakeholders to determine how to address them using the most up to date information around emerging state and federal laws, government enforcement actions, evaluation of Corporate Integrity Agreements, etc.
- Partner with business stakeholders to maintain an infrastructure that supports a culture of compliance and recognizes that compliance is a collective responsibility of all employees.
- Lead efforts to understand current and future compliance needs of business partners.
- Conduct routine meetings with key business leaders in the Commercial and Medical space.
- Develop tools, processes and reports to support the business's ownership of Compliance.
- Manage and lead quarterly Compliance Committee meetings.
- Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state government price reporting laws, state and federal privacy laws including GDPR, OIG and DOJ guidelines, PhRMA code and state marketing compliance laws.
- Provide guidance to the Business and integrate compliance controls into the scope of existing business practices where applicable.
- Provide regular updates and reports to the CCO and executive management on the operation and progress of compliance efforts and initiatives, audit findings, investigation outcomes, project status updates, as well as potential risks and proposed solutions.
- Manage and conduct compliance investigations involving potential violations of corporate policies, laws or regulations and oversee corrective action.
- Work with internal audit team to provide input on audit plans and work with the business to timely complete corrective action plans.
- Partner with legal and training functions to identify training needs, develop an annual training plan, create relevant training content and conduct effective training.
- Partner with legal and training functions to identify policy/guideline needs, develop/enhance policies and guidance documents and ensure optimal accessibility for the business using the most up to date technology.
- Support creation of a high-performing team environment that fosters growth and development through on-going coaching and mentoring
- Bachelors and/or Masters degree
- Minimum seven (7) years professional experience in a similar role or progressing to the Senior Director level of responsibility.
- Understanding of a commercial organizations’ needs
- Cross-border experience
- Pharmaceutical industry experience in a compliance or legal role
- Proven experience in consistently achieving results, even under tough circumstances
- Strong voice who can articulate in a persuasive and clear way; can influence without authority
- Makes good and timely decisions that keeps the organization moving forward
- Excellent judgement and strong ethical approach to compliance
- Ability to hold self and others accountable to meet commitments
- Able to anticipate and balance the needs of multiple stakeholders
- Comfort in working with senior management and employees at all levels
- Able to consistently live Aurinia’s core We Care values of creating opportunity, acting responsibly, relentlessly persevering and executing with integrity.
All your information will be kept confidential according to EEO guidelines.