The Senior Manager, Commercial Regulatory Operations, will support the end-to-end review and approval process for promotional and non-promotional materials, ensuring timely, compliant, and efficient execution across cross-functional teams. At Corcept, this review process is known as the "Content Review Team" (or "CRT"), which brings together three compliance disciplines (regulatory, legal, and medical) for review and approval of materials. This role will oversee and coordinate CRT logistics and operations with Veeva Vault system management.
This role requires strong organizational skills, familiarity with industry tools, and a collaborative mindset to help drive process excellence, audit readiness, and continuous improvement within a fast-paced, launch-focused environment. This is an excellent opportunity for someone looking to expand their pharmaceutical operations experience while contributing to a patient-centered, mission-driven company aiming to revolutionize the treatment of serious diseases.
This is a hybrid role typically requiring on-site presence at least 3 days per week.
Responsibilities:- Manage the end-to-end content review and approval process for promotional and non-promotional materials using the Veeva document management system
- Drive process improvement and operational efficiency initiatives within the CRT workflow
- Support system maintenance and enhancements in Veeva PromoMats and MedComms by managing administrative updates and light configuration changes
- Partner with Marketing teams on the development and maintenance of our claims and reference libraries
- Collaborate closely with Regulatory, Medical, and Legal colleagues to maintain efficient CRT workflows necessary for review and approval of all product and disease-related content proposed by Marketing, Medical Affairs or other teams and their agencies to communicate with external audiences
- Lead the planning and facilitation of CRT meetings, managing agenda creation, calendar coordination, expedited review processing, material quality checks, and consensus documentation
- In partnership with Regulatory colleagues, prepare timely and accurate FDA Form 2253 submissions
- Monitor and report on approval metrics to drive transparency, accountability, and data-informed decision-making across the review process
- Support prioritization and capacity planning to ensure review activities align with business objectives and key timelines
- Provide onboarding and training for CRT reviewers and content creators, such as marketers and their agencies, on CRT processes, system navigation, and best practices
- Provide project oversight and vendor management for ongoing enhancements and upgrades within our Veeva system
Preferred Skills, Qualifications and Technical Proficiencies: - Expertise in Veeva PromoMats/MedComms and promotional/non-promotional material review processes
- Ability to manage without direct authority and influence colleagues effectively
- Excellent analytical, problem-solving, and communication skills
- Highly organized, detail-oriented, and adaptable
Preferred Education and Experience: - BA/BS Degree in health/life sciences or related field
- 6+years' experience in pharmaceutical, life sciences, or related industry, including experience leading or supporting review committee meetings
- Product launch and pre-approval commercialization experience
- Experience in AI implementation, claims library maintenance, and Veeva administrative support
The pay range that the Company reasonably expects to pay for this headquarters-based position is $194,000 - $227,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
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Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
Please visit our website at: https://www.corcept.com/
