Senior Director, Legal & Compliance
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Job Description
Senior Director of Legal & Compliance at Cristcot focused on regulatory compliance in ulcerative colitis therapies. Leading compliance strategies and collaborating across teams in a pharmaceutical setting.
Responsibilities:
- Serve as a subject matter expert and strategic advisor to leadership and business stakeholders on complex compliance matters.
- Establish strong collaboration channels and relationships across our teams.
- Interface with external regulators as necessary.
- Analyze regulatory standards and publications to provide actionable insights and strategic compliance guidance to stakeholders.
- Develop compliance training programs, executive dashboards, and monitoring systems to identify gaps and validate program effectiveness.
- Lead cross-functional compliance initiatives across Finance, People, Marketing, Product, and other teams, while coordinating and leading the Compliance Committee.
- Lead the development, implementation, and management of an effective enterprise compliance program.
- Monitor commercial and non-commercial programs and contracts for adherence to company’s policies including its Code of Conduct.
- Provide compliance guidance on promotional and non-promotional materials to minimize risk and participate on promotional review committee.
- Serve as Legal reviewer on promotional review committee and non-promotional review committee.
- Review and approve annual engagement plans and business needs reviews for HCP engagement in connection with Commercial, Sales and Marketing and other departments, including review of HCP agreements.
- Provide Legal and Compliance review of agreements as needs arise.
- Develop and implement US compliance strategies that recognize the inherent risks in the pharmaceutical industry.
- Collaborate with internal Legal and Regulatory compliance team to implement tailored compliance initiatives and training programs.
- Conduct regular risk assessments to identify compliance issues and develop strategies to mitigate risks.
- Monitor and audit the effectiveness of the compliance program, and when necessary, conduct internal investigations into potential violations of our Code of Conduct and company policies.
Requirements:
- Juris Doctor (JD) from an accredited law school.
- Active bar membership in at least one U.S. jurisdiction.
- Minimum of 8–10 years of relevant legal and compliance experience in the pharmaceutical, biotechnology, or life sciences industry.
- Demonstrated experience supporting FDA-regulated products, preferably in gastroenterology, immunology, or specialty therapeutics (ulcerative colitis experience a plus).
- Hands-on experience with Medical Legal Review (MLR) and participation in Promotional Review Committee (PRC) processes.
- Strong working knowledge of FDA regulations, healthcare compliance laws, and industry codes (e.g., PhRMA Code).
- Experience operating in a small or emerging pharmaceutical company environment, with the ability to be both strategic and hands-on.
- Sound judgment with the ability to balance legal risk and business objectives.
- Strong communication, negotiation, and stakeholder management skills.
- High ethical standards and attention to detail.
- Ability to work independently and manage competing priorities in a fast-paced environment.
- Ability to travel <15%.
Benefits:
- Health insurance
- Professional development opportunities
- Flexible work arrangements
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