Director, Audits & Compliance

7 days left

Recruiter
Gilead Sciences, Inc.
Location
San Mateo
Salary
Competitive
Posted
23 Jul 2022
Closes
20 Aug 2022
Employer Sector
Technology, ICT & Telecoms
Contract Type
Permanent
Hours
Full Time
Travel
None
Director, Audits & Compliance
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company s five core values. That s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.

Job Description
Director, Audits & Compliance

Managed Markets Strategy & Operations (MSO)

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Job Responsibilities:
  • Governance of system (Model-N) and processes across MSO teams. Cross-functional coordination among sub-teams, and extensive synchronization with vendors and consultants to bring complex projects to completion.
    • Oversight of the annual upgrade and periodic releases of the revenue management system (Model-N) in collaboration with Associate Director. Includes cross-functional communication and management within MSO, as well as IT, Finance, SOX, and Legal; working in tandem with IT to evaluate upgrade/release content; solicit business needs; oversee the design of, and adherence to, a detailed project plan; strict follow up on issues; routine reporting to Steering Committee; and change management process.
    • Data integrity of systems, processes, and data (product launches, system changes or updates, etc.) in collaboration with Senior Manager.
  • Strategic oversight of 340B Program Integrity in collaboration with Associate Director:
    • Covered Entity data and analysis to address duplicate discounts.
    • Covered Entity Self-disclosure process.
    • HRSA audits of covered entities or contract pharmacies, if needed.
    • Approve Policies, Procedures, and Work Instructions.
  • Project Management of any pertinent MSO or Gilead initiative related to systems, processes, governance, and documentation (ex. - integrations, product launches).
  • SOX Compliance liaison and management:
    • Annual review with SOX PMO, internal and external auditors, and the MSO team. Includes controls, processes, documentation, and follow up on action items and recommendations.
    • In collaboration with MSO teams, establish and implement audits, corrective or preventative action plans, monitoring, documentation, and system testing (process/data/systems). Identify gaps and propose/implement strategic recommendations.
  • Monitor, audit, or assess certain activities or processes across MSO (as determined in Annual Risk Assessment or in routine work).
  • Oversight of the A&C Issues & Inquiries Inbox (managed by Senior Manager).
  • Support internal or external audits, as needed, to ensure results, action items and recommendations are addressed.
  • Compliance Training presentations on key topics in collaboration with Senior Manager. Regularly review and enhance existing policies, controls, training and awareness to support MSO's understanding and adherence to compliance program.
  • Approve and/or maintain Policies, Procedures, and Work Instructions.
  • Remain aware of US regulatory changes and market trends; attend conferences, webinars, etc.

Knowledge:
  • Comprehensive knowledge of pharmaceutical contracting, rebate and payment processes, and various market segments (Commercial, Medicaid, ADAP, 340B, Trade).
  • Extensive Project and Vendor Management experience, including system projects, audits, monitoring, and assessments.
  • Excellent cross-functional capabilities within the department, as well as with IT, SOX, Legal, Finance, Government Affairs, and external vendors.
  • Ability to recognize and interpret business issues/opportunities, analyze and recommend solutions, then implement and/or negotiate solutions.
  • Understanding of 340B regulations, legislation, rules, and guidance.
  • Strong knowledge of SOX principles and processes.
  • Robust experience with data analysis, systems, and working with IT teams.
  • Familiarity of government legislative issues and regulations.

Minimum Required Education and Years of Experience

Bachelor's Degree and Twelve Years' Experience

OR

Masters' Degree and Ten Years' Experience

OR

PhD and Eight Years' Experience

Preferred Qualifications:
  • 10+ years of pricing, contracting, and/or systems experience in biotech, pharmaceuticals, or a related industry. BS/BA degree; MBA or advanced degree highly preferred.
  • Management experience; project management and vendor management experience.
  • Ability to effectively partner with internal stakeholders to ensure compliant practices across all of MSO.
  • Strong cross-functional written and oral communication skills at all levels
  • Strong follow up capabilities

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, and Singapore employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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