Associate Director, Healthcare Compliance

Intellia•Cambridge, MA

6d•Onsite

About The Position

The Associate Director, Healthcare Compliance, will play a critical role in building and supporting Intellia’s Healthcare Compliance Program in connection with the commercialization of Intellia’s first product, a gene editing therapy for hereditary angioedema (HAE). This role will build, implement, and continuously improve Intellia’s Healthcare Compliance Program across a range of areas with a focus on monitoring, risk and compliance assessments, and transparency reporting through close partnership with the Commercial and Medical Affairs organizations, cross-functional collaboration, and a collective commitment to uphold Intellia’s integrity. This role will report to the Senior Director of Healthcare Compliance. This role requires strong initiative, a willingness to take on complex initiatives, and a desire to provide support across a fast-paced organization preparing to launch a novel therapy.

Requirements

Unimpeachable integrity, good judgment, assertiveness, an approachable demeanor, and the ability to elicit the respect and trust of employees
General knowledge of pharmaceutical laws, regulations and industry guidance pertaining to the commercialization of biopharmaceutical products
Experience in the biopharmaceutical industry and understanding of key commercial activities, including sales and marketing, HCP and patient engagements and interactions, and patient support services; launch experience and experience in rare disease is a plus
Self-starter who can lead projects independently from inception to completion with minimal supervision
Excellent communications skills, both verbal and written, including the ability to effectively lead presentations and deliver trainings
Exceptional organizational skills and attention to detail
Solid track record of building strong working relationships in a cross-functional matrix environment, working with different personality types, and managing conflict
Strong work ethic, positive outlook, commitment to legal and business teams
Collaborative style; team player
B.A./B.S. degree required
6+ years of healthcare compliance and/or other related experience in a commercial stage biotech/pharmaceutical organization
Prolonged periods of sitting at a desk and working on a computer
Ability to travel 15-20%

Nice To Haves

launch experience and experience in rare disease is a plus

Responsibilities

Develop and lead the annual risk-based monitoring plan as informed by ongoing risk assessments and emerging compliance needs.
Partner cross-functionally to facilitate auditable record-keeping.
Oversee and conduct live and transactions monitoring activities leveraging new and emerging technologies to drive efficiency and accuracy (e.g., AI solutions).
Identify trends, gaps, and areas for improvement, and report to senior leadership.
Work closely with Legal and Healthcare Compliance colleagues to conduct risk and compliance assessments.
Lead and manage the project lifecycle for compliance project initiatives
Maintain understanding of Intellia’s business objectives and activities and keep abreast of industry and enforcement trends that may impact Intellia’s operations and Healthcare Compliance Program.
Serve as Intellia’s subject matter expert on the Physician Payments Sunshine Act and related aggregate spend reporting and state transparency reporting requirements.
Partner cross-functionally to oversee the collection and compilation of reportable transactions, and reporting to national and state authorities.
Promote Intellia’s values and establish “Compliance by Design” principles as integral to achieving business objectives and improving processes and decision-making.