What are the responsibilities and job description for the Senior Director, Auditing and Monitoring position at Ardelyx?
Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.
Position Summary:
Reporting to the Senior Vice President of Legal and Chief Compliance Officer, the Senior Director, Auditing and Monitoring will be a key role on the Compliance Team managing all aspects of the Auditing functions, and providing significant guidance and input on compliance monitoring activities. This position will be responsible for the development of pharmaceutical compliance auditing plans focused on health care fraud and abuse risk, and assessing compliance with existing commercial compliance standard operating procedures. In addition, this role will partner with cross-functional teams to assess compliance with data privacy standards, federal and state transparency procedures, and certain commercial financial transactions. Specific experience with pharmaceutical industry compliance practices is required for this role.
Responsibilities:
- Develop and implement the annual compliance audit plan and schedules using a risk-based approach
- Conduct compliance audit engagements and prepare audit reports
- Participate in compliance monitoring
- Provide support and guidance to control owners as part of deficiency remediation efforts and as new systems are implemented or processes change
- Partner with internal and external stakeholders (process owners and external auditors) to build strong relationships and support the coordination of compliance audit activities
- Act as a trusted advisor to management, providing insights and recommendations to enhance business processes
- Stay abreast of industry developments and changes in regulatory requirements to ensure the internal audit function remains effective and relevant
Qualifications:
- Bachelor’s degree with 12 -15 years of related experience in healthcare / pharma / biotech, at least some of which is in an in-house environment or equivalent experience
- Excellent communication, collaboration, and presentation skills and strong attention to detail
- Effective time management skills with the ability manage competing priorities, operate in a proactive manner, and possess a results and solutions-oriented mindset
- Big 4 experience and certifications in accounting or auditing are preferred
- Demonstrated collaboration and teamwork with internal and external stakeholders
The anticipated annualized base pay range for this full-time position is $240,000-$294,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.
Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.
Ardelyx is an equal opportunity employer.
Salary : $240,000 - $294,000
