Senior Manager, Compliance Operations

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.

In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome).

Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.

What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.

The Senior Manager, Compliance Operations will provide support for the enterprise-wide compliance program. This position will play a key role in ensuring Corcept adheres to legal and regulatory standards by managing audits, monitoring processes, supporting investigations, and ensuring compliance with internal policies and procedures. This includes updating policies and procedures, providing training, collaborating with other departments, generating reports, and evaluating program needs to ensure that operations are appropriate to meet the program’s objective and long-range goals. 

This is a hybrid position typically requiring on-site presence 3 days per week.  Remote candidates will be considered if an exceptional fit.

This role reports to the Sr. Director of Legal who is responsible for Corcept’s Compliance Program.

Responsibilities:

• 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
• Audits and monitoring: Oversee internal and external audits, monitor processes for adherence to internal policies and procedures, and regulatory standards, and help analyze data to identify risks or areas for improvement
• Cross-functional collaboration: Work with Quality Assurance, Human Resources, and other departments to ensure consistent compliance practices across the organization
• Risk management: Conduct compliance program risk assessments and develop strategies to mitigate risks
• Operational Support: Assist the Compliance Program Lead with outreach and materials preparation for Corporate Governance Committee, Compliance Committee, and compliance working group meetings. Maintain the master compliance document repository and the various software tools used by the Compliance team (SharePoint, MedCompli, compliance hotline, etc.)

Preferred Skills, Qualifications and Technical Proficiencies:

• 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
• Strong communication skills—able to establish credibility and convey complex compliance matters clearly to diverse audiences
• Adept at learning new technical areas
• Experience with using and maintaining SharePoint sites, MedCompli and MediSpend, or other compliance software tools will be given consideration
• Self-driven to identify and solve complex and challenging problems
• Ability to understand business needs and exercise sound judgment on key decisions, including the ability to make independent decisions and recognize circumstances that require escalation
• Comfortable managing and prioritizing competing priorities and frequent interruptions while maintaining close attention to detail, accuracy and timeliness
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