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Associate Director, Compliance

Company: Pharmacyclics
Location: Sunnyvale
Posted on: November 20, 2019

Job Description:

SUMMARY:

The Associate Director, Compliance provides direct oversight for moderate to complex elements of Pharmacyclics' compliance program.

RESPONSIBILITIES:




  • The Associate Director may perform the following with minimal to moderate supervision:
  • Actively engage with business partners to understand and provide proactive compliance guidance on proposed business strategies and programs based on compliance policies, procedures, rules and regulations; identify moderate to complex healthcare compliance issues (e.g., fraud and abuse); propose and analyze alternatives; work with legal and other functions to appropriately mitigate potential risks.
  • Serve as primary compliance liaison to, and support for, managed access team.
  • Manage, assess and enhance the PCYC compliance monitoring program, including development and trending analysis of key performance indicator metrics. Together with business partners, develop and implement corrective and preventative action plans where appropriate to address monitoring findings.
  • Provide compliance support and guidance to business partners on program activities including Speaker Programs and Patient Support Programs.
  • Assess, enhance and implement changes to compliance program policies, procedures and processes to meet applicable requirements and address key emerging risks. Work with internal functions to provide advice and counsel, ensure appropriate training, and support adherence to policies/procedures relating to compliance matters.
  • Assist on compliance audits and serve as compliance liaison between the business and auditors during on-site activities. Evaluate and help respond to audit findings and recommendations, guide business partners in preparing corrective action(s), and work with business partners to ensure timely completion.
  • Prepare regular briefings to keep management up-to-date on latest industry events and trends including OIG and FDA enforcement statistics, CIA trends, changes to relevant industry codes, and transparency reporting requirements.
  • Participate in and lead moderate to complex cross-functional OEC programs.





    • Possess solid working knowledge of the pharmaceutical/biotechnology industry and understanding of laws and regulations applicable to pharmaceutical/biotechnology compliance.
    • 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 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. JD or MBA 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).



      Additional Information



      • Significant Work Activities and Conditions: N/A

      • Travel: No

      • Job Type: Experienced

      • Schedule: Full-time







Keywords: Pharmacyclics, San Francisco , Associate Director, Compliance, Executive , Sunnyvale, California

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