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PRC Coordinator

Lake Forest, IL

Posted: 10/10/2019 Employment Type: Contract Job Category: Clinical: Commercialization Job Number: 2457

As a PRC Coordinator, you will play an important role in coordinating our client’ s medical, regulatory and legal review in support of their various brands.  This is a highly interactive and cross-functional role where you will develop an understanding of the brand team’ s business and focus on effectively managing relationships with key stakeholders.

Responsibilities:
  • Facilitate, maintain and support the Promotional Review Process (medical, regulatory and legal review) of materials or information intended to be available to health care professionals, patients, consumers, or other customers, which refer to an approved or investigational product. 
  • Manage all day-to-day activities for assigned products of the Promotional Review Process which includes interaction with and training of both internal and external stakeholders (includes, but is not limited to, medical, regulatory, legal, marketing, etc.).
  • Plan and lead PRC meetings, prepares and maintains documents necessary for effective dialogue, and documents assignments, follow-up items and meeting outcomes. Ensures involvement of appropriate functions/individuals in relevant meetings, decisions and working groups.  Escalates matters as needed.
  • Support the Promotional Review Committee (PRC) document control process and systems; routing documents to internal and external reviewers and obtaining and collecting requisite signatures.
  • Lead weekly status meetings with assigned brand teams and agencies.
  • Ensure adherence to timelines for submission of material into the promotional review system.
  • Troubleshoot bottlenecks in workflow system.
  • Review assigned submissions for completeness and accuracy based on defined PRC standards.
  • Act as the point of contact and communicate project and process status adequately to all participants. Modify level of communication to meet audiences’ level of need to know basis.
  • Coordinate schedule of OPDP (FDA’ s Office of Prescription Drug Promotion) submissions with Regulatory team.
  • Effectively prioritize pieces during times of high volume - product launches, sales meetings, etc - balancing competing objectives to ensure deliverables are on time and within budget.

Requirements / Qualifications:
  • Bachelor’ s degree preferred (or equivalent work experience required)
  • 1-3 years’ experience in related field
  • Proficient in Microsoft Office
  • Professional demeanor
  • Self-starter attitude
  • Strong interpersonal skills
  • Excellent written and verbal communication skills
  • Demonstrates knowledge and experience with process management
  • Experienced in Veeva Vault PromoMats or related software preferred
  • Knowledge of pharmaceutical promotional regulations and submission requirements

Kelley Cole
Clinical Recruiter

Kelley brings 5 years of experience in full life-cycle recruitment and talent acquisition management, along with a strong client services background, to her role as Clinical Recruiter for The Steely Group. A desire to make a difference and add positivity to this world are two factors that influenced Kelley’s decision to become a recruiter. “Connecting a candidate with a better opportunity that could have a huge impact on them and their family is very fulfilling,” she says.

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