Position Overview
This position will manage aspects of Adaptive’s Compliance Program, will assist in the development of an annual compliance work plan, will assist in managing processes and creating necessary policies, will develop and provide compliance training and materials, provide transparency and guidance, and will generally work with internal stakeholders and the other members of the Compliance Team to continuously enhance Adaptive’s Compliance program based on the legal enforcement environment through application of best practices in the life sciences compliance space.
Key Responsibilities and Essential Functions
- Manage, provide oversight, and compliance guidance related to engagements with healthcare professionals globally
- Provide oversight and strategic direction related to sponsorships and grants requests
- Provide assistance in preparing and validating the federal and state transparency reports, such as the US Sunshine Act
- Provide strategic direction for the US Compliance function across all OIG seven elements of an effective compliance program leveraging knowledge of industry best practices
- Partner with and advise business stakeholders to prepare an annual compliance work plan based upon a comprehensive, annual 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, U.S. government enforcement actions, evaluation of Corporate Integrity Agreements, etc.
- Advise and provide support to business functions to maintain an internal infrastructure that supports a culture of compliance and recognizes that compliance is a collective responsibility of all employees
- Establish strong relationships with key internal stakeholders to understand current and future compliance needs
- Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including antikickback and fraud and abuse laws, transparency laws, OIG and DOJ guidelines, and industry standards, such as the AdvaMed and MedTech codes
- Provide guidance to the business and integrate compliance controls into the scope of existing business practices where applicable
- Partner with corporate compliance investigations regarding potential violations of compliance policies, laws or regulations and oversee corrective actions with business functions
- Work with internal audit to develop annual audit plans for the business and work with the business to timely complete corrective action plans
Position Requirements (Education, Experience, Other)
Required
- Bachelor’s degree and 7+ years, or Masters and 5+ years of recent, relevant in-house experience or law firm experience in a pharmaceutical, biotechnology, or lab industry
- Knowledge of and experience with US laws, regulations, and industry guidance that affect the pharmaceutical, biotechnology, or lab industry
Preferred
- JD or other advanced degree and 3+ years of experience
- Effective public speaking skills and an ability to communicate in both verbal and written form with multiple stakeholders within and outside the company
- Ability to lead and work effectively with cross-functional teams and projects
- Strategic leadership capability, strong organizational awareness, sound judgment, strong business acumen and ability to make decisions with input from multiple stakeholders
- Strong problem solving and risk analysis skills
- Sound judgment and commitment to ethical conduct
- Ability to effectively prioritize and work in a fast-paced environment and to handle multiple complex and confidential tasks
- Ability to manage and assist in the implementation of technical solutions to manage the HCP engagement and donation/sponsorship processes
Working Conditions
May have occasional travel
#LI-Remote
Compensation
Salary Range: $108,200 - $162,300
Other compensation elements include:
- equity grant
- bonus eligible
