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Promotional Review Associate (Promotional Review)
Ref No.: 18-13934
Location: Irvine, California
Position Type:Contract
Start Date / End Date: 10/15/2018 to 10/18/2020
Sunrise System Inc. is currently looking for Promotional Review Associate in Irvine, CA with one of our top client.
Job Title: Promotional Review Associate
Job Id: 18-13934
Location: Irvine, CA 92612
Duration: 24 months
Position Type: Hourly contract Position (W2 only)
 
Summary
  • The associate works cross-functionally to project manage the review process for advertising and promotional materials for approved drug and/or device products.
  • The associate is responsible for ensuring the efficiency of the MLR Committee process, involving Medical, Legal, and Regulatory teams, and for conformance with company policies and procedures. 
Primary Job Responsibilities
  • Lead and manage cross-functional promotional review (MLR) committee meetings. Build and manage meeting agendas as a partner to Marketing and facilitate meetings while memorializing MLR Reviewer comments and job requirements.
  • The associate should be comfortable dealing with participants of varying levels and experience, and be able to steer productive meeting discussions.
  • The associate is also responsible to manage all meeting logistics, including scheduling.
  • Manage all aspects of the review process for multiple brands.
  • The associate works independently on designated brands managing all aspects of both offline and live reviews.
  • The associate works closely with Brand Marketing, the MLR Committee, Compliance, and the rest of Marketing Operations, to proactively identify and resolve issues and ensure reviews are efficiently completed throughout various stages of the process.
  • Associate will utilize system and reporting to effectively communicate and actively manage jobs with Brand / Project Originators.
  • Enable best practices and SOP conformance. Use experience and judgment to identify jobs that may not be consistent with best practices, company policies or FDA guidance.
  • Associate also ensures that all SOP requirements are met. Provides guidance and training as required to all MLR participants.
  • Interface with Editorial, Production and Regulatory to assist with system execution of submission processes.
  • The associate is knowledgeable in each area to help with timely submissions and execution to ensure potential issues are resolved for overall achievement of deadlines (Proofing requirements, Regulatory Affairs return of jobs, 2253 submission to OPDP, etc.).
  • Collaborate with Marketing Operations, IT and Brand to provide feedback and support for process and system enhancements.
  • Associate will actively contribute to ongoing development in these areas as subject matter expert via weekly meetings and system testing for issue resolution and/or enhancements before pushing updates to the production environment.
  • Associate will take the lead or co-lead projects and/or assignments as required to ensure department goals are achieved.
Position qualifications
  • Experience working in a pharmaceutical or healthcare advertising environment
  • Familiarity with promotional review systems such as Veeva or Zinc strongly preferred
  • Moderate to Advanced Microsoft Skills (Outlook, Excel, Word, PPT)
  • Experience with editing helpful
  • Excellent interpersonal and collaboration skills
  • Project management skills and experience preferred
  • General understanding of FDA regulations for pharmaceutical advertising and promotion
  • Strong presentation and meeting facilitation skills
  • Bachelor's Degree and minimum of 1 year of experience 
Contact
Durga Prasad
Tel:  Direct: 732 272 0279  | Email: durgaprasad.b@sunrisesys.com
Or
Michael Peng
Direct: (732) 272 0265 | Michael@sunrisesys.com