Senior Manager, Compliance Operations

Corcept Therapeutics•Redwood City, CA

5d•$193,770 - $227,880•Hybrid

About The Position

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.

Requirements

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
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
Applicants must be currently authorized to work in the United States on a full-time basis.

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
If you possess strong compliance acumen, leadership skills, and the ability to influence outcomes while maintaining impeccable ethics, apply today!

Responsibilities

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
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
Support investigations into potential compliance violations, help implement corrective and preventive actions (CAPA), and ensure proper documentation
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
Work with Quality Assurance, Human Resources, and other departments to ensure consistent compliance practices across the organization
Conduct compliance program risk assessments and develop strategies to mitigate risks
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.)