Associate, Corporate Compliance

Zogenix, Inc.
Published
August 11, 2019
Location
Emeryville, CA
Job Type

Description

Summary

The core duties of the Associate’s role are varied and the right candidate will be able to manage multiple priorities while supporting the Compliance department in managing the day to day operations and project based assignments.

Responsibilities

    • Monitor and ensure compliance with state, local and federal regulations
    • Prepare, maintain and file physician payment data for all necessary Sunshine Act transparency reporting per Federal, State and International requirements
    • Compile necessary compliance data and prepare compliance audit findings
    • Support the development, implementation, and maintenance of compliance policies, including provision of advice and training on global policies and local compliance requirements
    • Manage and develop compliance systems, including application of appropriate internal controls and identification of process gaps as they arise
    • Facilitate ongoing maintenance of various healthcare compliance program-related activities and requirements, including but not limited to preparation of aggregate spend disclosure reports; record retention of meeting needs assessment forms for speaker programs, patient events, and advisory boards; monitoring; and investigations.
    • Attend compliance committee meetings and prepare minutes
    • Maintain current understanding of laws and regulations applicable to pharmaceutical/biotechnology compliance, along with recent industry trends and changes
    • Coordinate management of compliance-related projects and initiatives
    • Other adhoc duties as may be reasonably required by the business

 

Requirements

  • Bachelors’ degree, or equivalent combination of education and experience
  • Specialized training in relevant professional area is a plus e.g. compliance and ethics
  • A minimum of 2 years’ experience in pharmaceutical or healthcare compliance or as in-house legal support in similar field
  • Sound understanding of the compliance and regulatory framework affecting the pharmaceutical/biotechnology industry in the U.S. and across Europe
  • Motivated, self-starter with ability to appropriately prioritize issues and allocate resources
  • Ability to work independently and under pressure
  • Demonstrable experience of IT systems to process contracts and manage activity requests, proficiency in Microsoft Office Suite, Microsoft Project, Microsoft Visio, Concur expense reporting
  • Excellent written and verbal communication and interpersonal skills
  • Proven ability to work successfully in multi-functional, matrixed organization
  • Strong problem solving skills and ability to identify and address complex issues
  • Strong persuasive skills with employees including executive management and sound business judgment
  • Strong task-focused work ethic, including an ability to work to meet deadlines
  • Demonstrates unquestionable integrity and professionalism

Company Description

Zogenix is committed to developing and commercializing therapies for central nervous system disorders that address specific clinical needs for people living with rare diseases and other CNS disorders who need innovative treatment alternatives to improve their daily functioning.

We seek best-in-class leaders with scientific, medical and commercial expertise in the therapeutic areas in which we participate. By sharing a collective passion for making a difference in the lives of patients we serve, our unique company culture thrives through the principles of ethical decision making, open communication and collaboration.
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