Senior Manager, Compliance Operations

Corcept Therapeutics • Redwood City, CA

1d • Hybrid

About The Position

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.
Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.
Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com.
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.
This role reports to the Sr. Director of Legal who is responsible for Corcept’s Compliance Program.

Requirements

• Understanding of the laws and regulations impacting pharmaceutical compliance (False Claims Act, Anti-Kickback Statute, HIPAA, 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
• 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
• A mindset for continuous improvement and a willingness to educate the business about compliance
• 7-9+ years of experience in a compliance operations role (preferably in the pharmaceutical/life sciences industry), with a track record of building and managing compliance programs

Nice To Haves

• Experience with using and maintaining SharePoint sites, MedCompli and MediSpend, or other compliance software tools will be given consideration
• Bachelor’s degree preferred. CHC/CPCO/CCEP/CCP Certification a plus

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.)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees