PRC Medical Reviewer IV Job at SSi People, Princeton, NJ

QVV0K3Bmb2V3MVVXMFFvYng0aHl2a2d4MGc9PQ==
  • SSi People
  • Princeton, NJ

Job Description

Job Title: PRC Medical Reviewer IV

Location: Princeton, NJ

Job Responsibilities:

  • Conduct comprehensive regulatory reviews of promotional material to ensure compliance with FDA advertising and promotion regulations. This includes healthcare professional materials, direct-to-consumer campaigns, sales training materials, disease awareness and unbranded campaigns, and corporate materials.
  • Participate in cross-functional promotional review committees as the Promotion Compliance/Regulatory Advertising and Promotional reviewer.
  • Ensure promotional claims align with approved labeling, are supported by data, comply with regulations, and are consistent with company policy.
  • Stay updated on evolving FDA guidance and apply this knowledge to ongoing review work.
  • Support additional promotional-compliance-related activities as agreed.

Skills Required:

  • 10+ years of hands-on experience in Regulatory Advertising and Promotional Review in the pharmaceutical or biotech industry.
  • Strong familiarity with FDA regulations and guidance related to advertising and promotion.
  • Specific experience with CFL guidance is required, and experience with newer SIUU guidance is preferred.
  • Prior experience in CNS or nephrology therapeutic areas is preferred.
  • Prior experience with Veeva Vaults Promo mats is highly preferred.
  • Ability to articulate regulatory rationale in both written and verbal formats.
  • Deep understanding of how to evaluate promotional claims consistent with clinical data and labeling.
  • Solid knowledge of clinical trial design and statistical principles sufficient to interpret efficacy and safety data.
  • Collaborative and solution-oriented team player who contributes positively to cross-functional discussions.
  • Comfortable working in a fast-paced, matrixed environment with cross-functional business partners.

Job Tags

Similar Jobs

DataAnnotation

Biotech Research Scientist Job at DataAnnotation

 ...We are looking for a Biotech Research Scientist to join our team to train AI models. You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the quality of each model. In this role you will need to hold an expert understanding... 

AEG

Events Manager Job at AEG

Company Overview: Topnotch Management (TNM) is a boutique sports management agency representing some of the world's top tennis and pickleball players. Through Topnotch Events, we manage, own and operate and several top-tier professional racquet events, including Tennis... 

MaxCyte

Senior or Principal Scientist (Waltham) Job at MaxCyte

 ...genome editing, molecular biology, genomics, or related field with 4+ years of relevant post-graduate experience in an academic or biotech setting Deep technical knowledge and hands-on experience in high sensitivity genome editing, off-target nomination and confirmation... 

The Morning Star Trucking

Local Class A Truck Drivers Free Housing For the Season Job Job at The Morning Star Trucking

Local Class A Truck Drivers Free Housing For the Season JobMorning Star Trucking will cover the costs of your training, if you agree to drive for us this season (July to October). And you will make money along the way. Class "A" Truck Drivers Needed For the 2018 Season... 

The Malt House FiDi

Restaurant Bar Manager Job at The Malt House FiDi

 ...Job Description Job Description Join Our Team as a Bar Manager at The Malt House ! At The Luxe Lounge , we pride ourselves on creating an unforgettable experience for our guests. Nestled in the heart of the Financial District, our upscale bar features a sophisticated...