PRC Coordinator (Regulatory Affairs Team)

Benefits Offered

401K, Dental, Life, Medical, Vision

Employment Type

Full-Time

“We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders”

Intra-Cellular Therapies is a biopharmaceutical company committed to the development of novel CNS drugs, leveraging innovative technology based on the pioneering efforts of ITCI co-founder and Nobel laureate, Dr. Paul Greengard. ITCI has a diverse portfolio of approved and investigational compounds across different stages of clinical development. Our lead candidate, lumateperone (CAPLYTA®), is FDA-approved for the treatment of schizophrenia in adults as well as for the treatment of bipolar depression in adults as monotherapy and as adjunctive therapy.

This position is responsible for overseeing US promotional review operations, including routing all promotional material through a review/approval process, scheduling/leading live Promotional Review Committee (PRC) meetings, and ensuring that all feedback is incorporated before materials are approved for distribution. This individual will work as a liaison between the brand, agency partners, and reviewers to manage and enhance the PRC process. They will be the main point-of-contact for the end-to-end PRC document lifecycle process.

Responsibilities:

• Ensure all promotional materials are properly vetted through the review process utilizing the cloud-based review system (Veeva PromoMats). Manage the material’s lifecycle according to our standard operating procedure (SOP).
• Capture consensus during live PRC meetings, provide editorial review of all materials, and submit appropriate materials to the Office of Prescription Drug Promotion (OPDP).
• Onboard and conduct Veeva system and standard operating procedure (SOP) training for Internal and External parties.
• Partner with marketing/sales training team to assist with prioritization (e.g., launch, sales meetings, label updates). Maintain and update a PRC calendar of upcoming jobs and distribute an agenda prior to each meeting.
• Oversee, track, and ensure annual review of all promotional material.
• Obtain source files of approved materials and store electronically.
• Update SOP and other PRC process documents as needed.
• Stay current with industry trends, changes, and requirements related to promotional review.
• Generate quarterly metrics from Veeva PromoMats on job volume and overall PRC performance.
• Perform other regulatory tasks as assigned. 

Requirements:

• Bachelor’s Degree
• 1 to 2 years of experience working and collaborating with multiple stakeholders and adhering to timelines. This experience can be in pharma or any other industry.  
• Ability to work in a complex and cross-functional environment
• Sound judgement and attention to detail
• Exceptional communication and problem-solving skills
• Ability to manage multiple projects simultaneously
• Strong interpersonal, teamwork, and organizational skills
• Ability to act independently and take initiative
• Excellent computer skills, with experience using Microsoft Office
• Experience with Veeva PromoMats system or similar a plus, but not required
• Available to travel for conferences or team meetings occasionally 
• Complete all company and job-related training as assigned within the required timelines.
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
• Must be able to perform all essential functions of the position, with or without reasonable accommodation. 

Key Stakeholder Relationships

Regulatory, Legal/Compliance, Medical, Marketing, Creative Agencies

Intra-Cellular Therapies is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, disability or any other legally protected status.