Alnylam was founded in 2002 on a revolutionary vision and bold mission which remain firmly in place today. We are leading the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to transform the lives of people with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system diseases with unmet need. Our first medicine, the first-ever RNAi therapeutic, has recently been approved by the FDA in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults and by the European Medicines Agency in the EU for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 polyneuropathy.
Reporting to the Senior Director, US Regional Lead, Ethics & Compliance, the Associate Director will support the design, implementation, and enhancement of an effective ethics and compliance program for Alnylam's US Business. The Associate Director will work closely with colleagues in the broader Ethics & Compliance team, and with regional Legal and business colleagues to sustain Alnylam's strong ethical culture and ensure employee adherence to the Company's Code of Conduct and related rules, policies, and procedures.
Summary of Key Responsibilities
- Partner with employees and leadership to maintain and further develop throughout the organization a strong culture of ethics and compliance, including personal accountability at all levels in the organization with a spirit of partnership and positive problem solving
- Assist to evolve the compliance program within the US Region and ensure that it is consistent with the values and principles of the organization, fit for purpose and complies with applicable requirements
- Draft and/or update appropriate policies to ensure compliance with applicable laws, regulations and industry codes and alignment with global policies
- Support the implementation and maintenance of US federal and state transparency reporting requirements and assist business leadership in meeting reporting obligations
- Assist in implementation and execution of risk based third party due diligence
- Support the implementation of a robust privacy program and help pull through privacy requirements within the US Business
- Prepare and deliver training and education to ensure understanding of employee responsibilities and ethics and compliance issues, as well as related policies and procedures
- Execute routine and risk based monitoring and auditing of relevant US Business activities and related policies and procedures; identify potential areas of compliance vulnerability and risk; assist in and oversee the implementation of corrective action plans as necessary; and generate reports on monitoring, auditing and risk assessment for the US Business
- Travel required
- Other responsibilities as may be assigned from time to time in the company's discretion.
- Bachelor's Degree required. Juris Doctor strongly preferred, other relevant accreditations or degrees considered
- Minimum of 7 years of ethics, compliance and/or legal experience in an organization subject to US biopharmaceutical, medical device or other relevant healthcare compliance laws and regulations
- Demonstrated ability to work collaboratively and cross-functionally in a team environment with a wide variety of company personnel on a broad range of matters
- Ability to manage multiple tasks simultaneously and to flourish in a fast-paced and high energy environment
- Able and eager to work independently and to manage and oversee discrete areas of responsibility with little direct supervision
- Able to thrive in a proactive ethical culture in which compliance and business objectives are mutually reinforcing; strong motivation and ability to champion a comprehensive compliance program that is integrated well with the Company's business and culture
- Excellent organization, communication (verbal and written – fluency in English required) and prioritization skills, including the ability to communicate concisely, to integrate legal and business considerations, and to provide balanced advice regarding risks
- Experience with privacy and transparency reporting a plus.