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Manager, Compliance

Employer
AbbVie
Location
Lake County, Illinois
Start date
May 18, 2023

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Discipline
Regulatory, Legal/Compliance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work
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Job Details

Purpose:


Develop, implement, and administer compliance monitoring and related training content for all U.S. based Sample activities. Provide compliance direction and guidance and support to internal Home Office and Customer-Facing teams. This position has a direct impact on sample compliance with State and Federal regulations including, but not limited to, the Prescription Drug Marketing Act (PDMA) and the Patient Protection and Affordable Care Act. Serve as the corporate SME for sample compliance-related questions and issues.    

Responsibilities:

  • Monitor sample activity metrics for trends in rep behaviors, provide coaching on best practices and counseling on policy violations; investigate broader trends for potential process improvements.
  • Evaluate and recommend adjustments as necessary to Sample related processes, procedures, and policies to ensure compliance with relevant regulations.
  • Develop, implement, and maintain a sampling process training strategy for all sampling representatives and district managers, as well as Home Office employees and third-party vendors.
  • Develop and maintain working relationships and collaborate with cross-functional areas including Sample Operations, Legal, OEC, BTS, Field Tools, Digital Learning, CAM, QA, and primary third-party vendors.
  • Support resolution of situational compliance concerns via the Helpdesk, OEC, third-party vendors or direct from Customer-Facing personnel; educate and become a trusted resource. 
  • Final USCC team reviewer and approver of certain vendor business requirements to insure alignment with regulations and policies. 
  • Primary liaison with QA regarding exception reporting and corrective actions, support root cause investigations, identify gaps, and determine department action plan. 
  • Participate in professional organizations, user groups, and industry trade groups and peers to keep abreast of best practices in Samples compliance.
  • Develop and implement USCC team audit readiness framework for internal and external audit activities, function as SME, and ensure audit readiness.

    • Qualifications:

  • Bachelor's degree required. 
  • Previous pharmaceutical experience required.
  • Minimum of 6 years’ experience with, or exposure to, business functions such as compliance, audit, legal, medical, regulatory affairs, or finance.
  • Background in monitoring and/or auditing, analytics, and reporting, including the use of business intelligence tools (for example Power BI) to aggregate, analyze, visualize, and share data.  Ability to evaluate and continuously improve monitoring and reporting activities.
  • Experience with regulatory audits and practices (specifically PDMA) preferred.
  • Significant project management experience and demonstrated organizational skills.
  • Ability to clearly and confidently articulate complex and difficult concepts.
  • Demonstrated ability to communicate effectively, present professionally, and use tact and diplomacy to work well with multiple levels and across the organization.

    • #LI-Hybrid

    AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.


    Company

    AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.

    Stock Symbol: ABBV

    Stock Exchange: NYSE

    Find Us
    Website
    Phone
    1-800-255-5162
    Location
    1 North Waukegan Road
     North Chicago
    Illinois
    60064
    US
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