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Promotional Review Coordinator

2 months ago

Bedminster, New Jersey, United States INTRA-CELLULAR THERAPIES INC Full time
Job Overview

Company: Intra-Cellular Therapies Inc.

Position Type: Full-Time

Benefits: 401K, Dental, Life, Medical, Vision

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

Intra-Cellular Therapies is a biopharmaceutical organization dedicated to the advancement of novel CNS medications, utilizing cutting-edge technology inspired by the groundbreaking work of co-founder and Nobel laureate, Dr. Paul Greengard. Our diverse portfolio includes both approved and investigational compounds at various stages of clinical development, with our leading candidate, lumateperone (CAPLYTA), receiving FDA approval for the treatment of schizophrenia and bipolar depression in adults.

Key Responsibilities:

  • Oversee the US promotional review operations, ensuring all promotional materials are thoroughly vetted through the review process using the cloud-based system (Veeva PromoMats).
  • Facilitate live Promotional Review Committee (PRC) meetings, capturing consensus and providing editorial oversight on all materials submitted to the Office of Prescription Drug Promotion (OPDP).
  • Conduct onboarding and training sessions on the Veeva system and standard operating procedures (SOP) for both internal and external stakeholders.
  • Collaborate with the marketing and sales training teams to prioritize projects, maintaining a PRC calendar and distributing agendas prior to meetings.
  • Monitor and ensure the annual review of all promotional materials, obtaining source files of approved content for electronic storage.
  • Update SOPs and PRC process documentation as necessary, staying informed on industry trends and regulatory changes.
  • Generate quarterly metrics from Veeva PromoMats to assess job volume and overall PRC performance.
  • Perform additional regulatory tasks as assigned.

Qualifications:

  • Bachelor's Degree required.
  • 1 to 2 years of experience collaborating with multiple stakeholders and adhering to timelines, preferably in the pharmaceutical industry.
  • Ability to navigate a complex, cross-functional environment.
  • Strong judgment, attention to detail, and exceptional communication skills.
  • Proficient in managing multiple projects simultaneously with strong organizational skills.
  • Ability to work independently and take initiative.
  • Excellent computer skills, including proficiency in Microsoft Office.
  • Familiarity with Veeva PromoMats or similar systems is a plus.
  • Willingness to travel occasionally for conferences or team meetings.
  • Complete all required company and job-related training within designated timelines.

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.