Quality & Compliance
Senior Manager, Healthcare & Data Privacy Compliance
Office Location: Pasadena, CA
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The purpose of this position within the Quality and Compliance department is to support the development and ongoing management of Arrowhead’s healthcare compliance and data privacy programs and policies worldwide. A key function of the position will involve supporting the development, maintenance, monitoring, and execution of the compliance program and corporate policies at Arrowhead.
This position will report to the Director of Compliance and will work closely with members of the Legal, Commercial, Medical Affairs, Regulatory, Quality teams to promote awareness and understanding of positive ethical principles and ensure continuous suitability and alignment of compliance program framework and controls relevant laws and company’s goals.
This role is based in Pasadena or San Diego, California, with an expectation to be in office 5 days a week.
Responsibilities
- Serve as an internal subject matter expert in the field of healthcare compliance and advise internal stakeholders and management on matters related to healthcare compliance.
- Support the implementation of company-wide healthcare compliance and data privacy program, policies, and controls.
- Support the development and implementation of relevant and robust policies and other guidance documents to ensure compliance with applicable laws and regulations, and industry standards.
- Drive culture of compliance by developing written materials and training that are aimed at increasing stakeholders’ awareness and understanding of relevant regulatory requirements and industry standards.
- Support audit action plans and/or corrective action plans, including designing remedies and supporting the business in implementing, tracking and completing their plans as required.
- Conduct compliance risk assessments and coordinate implementation of necessary mitigation actions, aligned with evolving regulatory requirements, industry standards, and business initiatives and strategies.
- Support the Director of Compliance and Legal department in conducting internal investigations related to the compliance program and if required, implementation of applicable corrective and preventative measures and reporting to relevant government agencies.
- Participate in the due diligence of third parties engaged in activities related to healthcare compliance and/or data privacy.
- Prepare and present periodic reports and status of compliance to management, including the measures and activities to ensure compliance.
- Other duties as assigned.
Requirements:
- Bachelor’s degree in business, healthcare, or related area of study,
- 5 years of relevant experience.
- Working knowledge of Federal Anti-Kickback Law, False Claims Act, US FDA and EMA Laws and Regulations, Transparency reporting laws, relevant Federal and State Consumer Protection Laws, PhRMA Code, ACCME, and EEPIA standards.
- Competent knowledge of and ability to use Microsoft Office suite.
Preferred:
- Prior experience with use of an electronic document management system in a regulated environment
- Relevant Compliance and ethics Professional certification
- Masters Degree
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.