Senior Director, Legal & Compliance
Cristcot
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Juris Doctor (JD)FDA regulationshealthcare compliance lawsMedical Legal Review (MLR)Promotional Review Committee (PRC)compliance training programsrisk assessmentscompliance program monitoringstrategic compliance guidancecontract review
Soft Skills
strong communicationnegotiation skillsstakeholder managementsound judgmentattention to detailability to work independentlymanage competing prioritiescollaborationstrategic thinkingleadership
Certifications
active bar membership