Associate Director, Compliance

Location
Cambridge, MA, United States
Posted
Jul 26, 2018
Ref
1224224
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Job Summary

The Senior Manager/Associate Director, Compliance will serve an important role in bluebird bio's continued enhancement of its Compliance program. This position will work to assist in the implementation, maintenance, and continued improvement of bluebird's culture of embracing compliant practices and behaviors through close collaboration with internal and external business partners. This position will report to the Senior Director, Healthcare Compliance.

Duties and Responsibilities
  • Oversee the implementation of a global aggregate spend solution and subsequent reporting/certification of transparency report submissions
  • Conduct in-person monitoring of Medical and Commercial activities to ensure compliance with applicable laws, regulations and company policies
  • Review Medical and Commercial documentation to ensure compliance with company SOPs and policies
  • Collaborate with internal departments for various monitoring requirements
  • Track and report progress of Compliance audit and monitoring
  • Provide training to internal organizational clients with respect to topics such as anti-bribery, FDA regulations, transparency reporting, and company policies
  • Assist with drug price reporting for various state and federal reports
  • Develop and/or identify new work processes, tools or resources that will have broad applicability throughout the organization; contribute ideas for achieving organizational goals.
  • Proactively identify opportunities where Global Compliance can add value to the Company.
  • Requires the ability to be flexible and adaptable to changes. This individual must feel comfortable in creating new processes and grow with the organizational and regulatory changes.

Qualifications

State the minimum qualifications required to successfully perform the job.
  • A./B.S. degree or equivalent required. Advanced degree preferred.
  • 7 - 10 years in compliance, audit and/or other related experience required. Pharmaceutical experience required.
  • Certified in Healthcare Compliance (CHC) or Project Management Professional (PMP) a plus.
  • Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including global aggregate spend and other reporting/sunshine laws, fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, and state marketing and price reporting compliance laws.
  • Experience developing and executing a global audit and monitoring plan.
  • Advanced skills in Microsoft Office Suite, as well as previous significant experience using report building software such as Cognos Report, Query Studio or a similar software package.
  • Strong operational and project management skills required.
  • Excellent organization, communication and presentation skills. Candidate must have strong team orientation and problem-solving skills.


Working Environment
  • Office/administrative within bluebird bio's Corporate Headquarters.
  • ~25-40% travel

bluebird bio, Inc. provides equal employment and affirmative action opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.