Associate Director, Compliance Training
Job Details
- Experience
- At least 8 years of progressive experience in the pharmaceutical or biotechnology industry, including a minimum of 5 years in healthcare compliance, compliance training, or commercial training with a significant compliance component.
Requirements
- Bachelor’s degree required.
- At least 8 years of progressive experience in the pharmaceutical or biotechnology industry.
- At least 5 years in healthcare compliance, compliance training, or commercial training with a significant compliance component.
- Demonstrated experience building and managing compliance training programs for US commercial operations, including field sales and product launch environments.
- Strong working knowledge of US healthcare laws and standards, including FDCA, FDA promotional regulations, the federal Anti-Kickback Statute, False Claims Act, OIG compliance guidance, PhRMA Code, and Sunshine Act/Open Payments requirements.
- Expertise in instructional design and adult learning principles, with experience using Articulate Storyline, Articulate Rise, or Adobe Captivate.
- Hands-on experience administering training content and generating reports through an LMS.
- Excellent presentation and facilitation skills, and strong written communication skills to turn complex legal and regulatory concepts into actionable guidance.
- Ability to lead through influence, manage multiple projects under tight deadlines, and collaborate across functions without direct authority.
- Willingness and ability to travel domestically approximately 10–15% of the time.
- Preferred: advanced degree or relevant certification such as CCEP, CHC, CPTD, or an instructional design certification.
- Preferred: experience supporting oncology or specialty pharmaceutical product launches, or working under a Corporate Integrity Agreement.
- Preferred: familiarity with Workday Learning, Cornerstone, or SuccessFactors; learning analytics; state marketing and transparency laws; HIPAA; or video-based, gamified, or scenario-driven learning.
Responsibilities
- Lead the US commercial compliance training program, including annual training plans, curriculum roadmaps, and training calendars.
- Design and develop role-specific learning materials, including eLearning, instructor-led sessions, microlearning, case studies, job aids, certifications, and interactive scenarios.
- Create training on healthcare compliance topics, including healthcare professional interactions, promotional communications, anti-kickback requirements, transparency reporting, privacy, and patient support programs.
- Apply adult learning principles and instructional design methodologies for field sales, Market Access, Medical Affairs, Marketing, and home-office teams.
- Lead compliance onboarding and deliver launch-readiness training for new products, indications, and field force expansions.
- Facilitate training at national and regional sales meetings, POA meetings, and cross-functional forums; provide train-the-trainer support.
- Manage compliance training content and administration within an LMS, including curriculum assignments, completion tracking, reporting, and system enhancements.
- Establish and monitor training KPIs, report outcomes to Compliance leadership and the Compliance Committee, and maintain audit-ready documentation.
- Collaborate with cross-functional stakeholders and incorporate monitoring, audit, and investigation insights into targeted remediation efforts.
- Manage external training vendors and instructional design agencies, and develop compliance awareness campaigns and communications.