Remote Regulatory Medical Reviewer Job at Collabera, San Francisco, CA

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  • Collabera
  • San Francisco, CA

Job Description

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Remote Regulatory Medical Reviewer

Contract: San Francisco, California, US

Salary Range: 45.00 - 54.00 | Per Hour

Job Code: 358172

End Date: 2025-02-27
Days Left: 17 days, 2 hours left

Apply

Job Description:

Key Responsibilities:

  • Review Promotional Materials: Evaluate promotional claims to ensure medical accuracy and compliance with FDA guidelines, focusing on both oral agents and drug-device combination products.
  • Regulatory Compliance : Ensure all promotional materials meet FDA regulatory standards and guidelines, providing the necessary medical oversight for compliant messaging.
  • Cross-functional Collaboration: Work closely with commercial, medical affairs, and regulatory teams to ensure the accuracy and compliance of promotional assets for product launches.
  • New Launches & Therapeutic Areas : Contribute to the creation of new promotional materials, particularly for new oral launch assets and in the therapeutic area of Parkinson's disease.
  • Guidance & Consultation: Provide guidance on the medical accuracy and regulatory compliance of various promotional materials, including print, digital, and other promotional assets.
  • Review & Approve Materials: Review and approve promotional materials across various formats, ensuring they align with both regulatory requirements and medical accuracy.

Required Experience & Skills:

  • Experience: At least 3 years of experience reviewing promotional claims, with a focus on medical accuracy and FDA compliance.
  • Medical Accuracy & FDA Compliance: Proven ability to review promotional materials for the pharmaceutical industry, ensuring they meet FDA guidelines.
  • Systems Knowledge: Familiarity with promotional review systems such as PromoMats and MedCom. Experience with other similar systems will also be considered.
  • Advanced Degree: An advanced degree (Pharm D, PhD, MD, DO) is preferred. Other healthcare providers, such as Nurse Practitioners or Physician Assistants, with relevant experience, will also be considered.
  • Therapeutic Experience: Experience in the Parkinson's therapeutic area is a plus but not required.
  • Product Experience: Prior experience with pharmaceutical promotional review is preferred. Experience with drug-device combination products is a plus but not essential.

Systems & Tools:

  • Experience with PromoMats and MedCom systems is highly preferred. Candidates with similar systems experience, such as Viva, will also be considered.

Preferred Background:

  • Strong experience in pharmaceutical promotional review.
  • Experience in the Parkinson's therapeutic area (preferred but not required).
  • Experience with drug-device combination products (a plus).

Pay Range: $45/hr. - $54/hr.

Job Requirement

  • Therapeutic Knowledge
  • Promotional Material Review
  • FDA
  • Documentation
  • Parkinson's therapeutic area
  • PromoMats
  • Veeva
Reach Out to a Recruiter

  • Recruiter
  • Email
  • Phone
  • Vishnu Nair
  • vishnu.nair@collabera.com

Apply Now Collabera

Job Tags

Remote job, Hourly pay, Contract work,

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