Senior Manager, Compliance Operations

Nice to have:

Understanding of the laws and regulations impacting pharmaceutical compliance (False Claims Act, Anti-Kickback Statute, HIPPA, the Stark Law, etc.)

Working knowledge of the elements of an effective compliance program, the PhRMA code, and the role of compliance in prevention and oversight

Proven ability to develop and maintain comprehensive and impeccably organized documentation including policies, procedures, and evidence collection

Documentation and reporting

: Oversee the updates to and maintenance of Corcept’s policies, procedures, work instructions, training materials, and other compliance-related documents. Develop a framework for evaluating how compliance documents are assessed for fitness and accuracy and when updates are required. Compile and analyze compliance data for internal reporting

Training and education

: Develop, implement, and deliver compliance training programs for employees that align with program and organizational goals. Develop and maintain appropriate tools to track and report employee training completion metrics

Investigations and corrective actions

: Support investigations into potential compliance violations, help implement corrective and preventive actions (CAPA), and ensure proper documentation