Associate Director, Compliance
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
Associate Director, Compliance
The Associate Director, Compliance, provides direct oversight for moderate to complex elements of Pharmacyclics' compliance program, including transparency reporting and compliance monitoring.
The Associate Director may perform the following with minimal to moderate supervision:
- Provides guidance on proposed business strategies and programs based on compliance policies, procedures, rules and regulations; identifies moderate to complex healthcare compliance issues (e.g., fraud and abuse, transparency, monitoring); proposes and analyzes alternatives, and works with legal and other functions to appropriately mitigate potential risks.
- Work with internal functional areas to provide advice and counsel, ensure appropriate/adequate training, and support adherence to policies/procedures relating to compliance matters.
- Maintain current understanding of laws and regulations applicable to pharmaceutical/biotechnology compliance, along with recent industry trends and changes.
- Prepare regular briefings to keep Executive Management up-to-date on latest industry events and trends including OIG and FDA enforcement statistics, CIA trends, global enforcement trends, changes to relevant industry codes, and transparency reporting requirements.
- Assess, enhance, and implement changes to compliance program policies, procedures and processes to meet applicable requirements and address key emerging risks.
- Assist with creation and execution of training plan and training modules in connection with compliance policies and procedures.
- Assist with coordination, management, assessment, enhancement and execution of healthcare compliance monitoring program, including maintenance of certain record keeping and metrics tracking systems.
- In conjunction with business partners, develop and implement corrective and preventative action plans where appropriate to address monitoring findings.
- Assists more senior OEC employees on compliance audits, when necessary, such as overseeing the fulfillment of auditors' requests and acting as a liaison between the business and auditors during on site activities.
- Expected to evaluate and help respond to moderate to complex preliminary audit findings and recommendations, and to guide the business in preparing corrective action(s) to address moderate to complex findings and recommendations, and work with the business to ensure timely completion.
- Serve as primary compliance advisor to the Aggregate Spend function on state and federal transparency reporting requirements, including supporting their efforts to maintain, enhance, and conduct training on associated policies, procedures, and processes.
- Partner with Aggregate Spend function to provide business function leadership periodic analytics to support the annual attestation process and ensure timely, accurate, and complete aggregate spend reporting.
- Possesses solid working knowledge of the pharmaceutical/biotech industry,
- Pharmacyclics' business, the current compliance environment.
- Participates in and may lead moderate to complex cross-functional OEC programs.
- May have direct reports.
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance
- Proven ability to influence individuals over whom there is not a direct reporting relationship
- Learns, fast, grasps the 'essence' and can change the course quickly where indicated
- Raises the bar and is never satisfied with the status quo
- Self-starter who requires little day-to-day oversight
- Possesses strong organizational skills and is able to track and oversee projects with great attention to detail
- BA/BS required. MBA or JD is strongly preferred.
- Minimum of 6-8 years experience in the pharmaceutical/biotechnology/medical device field (in-house, consulting, or law practice) with, or having significant exposure to, healthcare compliance (e.g., sales and marketing fraud and abuse issues, OIG and industry association guidance documents and codes, etc).
- Prior in-house pharmaceutical/biotechnology/medical device industry experience is preferred.