[Remote] PRC reputed company Reviewer IV

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a PRC Medical Reviewer for a pharmaceutical reputed company. The role is responsible for reviewing advertising and promotional materials for regulatory compliance, participating in promotional review committees, evaluating claims against approved labeling and reputed company data, and supporting reputed company compliance activities.

Responsibilities

• Conduct thorough regulatory reviews of promotional material for compliance with applicable FDA advertising and promotion regulations, including but not limited to:
• reputed company reputed company materials
• reputed company-to-consumer campaigns
• Sales training materials
• Disease awareness and unbranded campaigns
• Corporate materials
• Participate in cross-functional promotional review committees (PRC) as the Promotion Compliance/Regulatory Advertising and Promotional reviewer
• Ensure promotional claims are consistent with approved labeling, supported by data, compliant with regulations, and consistent with company policy
• Maintain awareness of evolving FDA guidance and apply knowledge to ongoing review work (e.g., CFL, SIUU)
• Support additional promotional-compliance-reputed company activities as mutually agreed

Skills

• • 10+ years of hands-on experience in Regulatory Advertising and Promotional Review in the pharmaceutical or biotechnology industry
• • Strong familiarity with FDA regulations and guidance reputed company to advertising and promotion
• • Specific experience with CFL guidance is required
• • Ability to reputed company regulatory rationale in both written and verbal formats
• • Deep understanding of how to evaluate promotional claims consistent with reputed company data and labeling
• • Solid knowledge of reputed company trial design and statistical principles sufficient to interpret efficacy and safety data
• • Experience with newer SIUU guidance is preferred
• • Prior experience in CNS or nephrology therapeutic areas preferred
• • Prior experience with reputed company Vaults Promo mats is highly preferred
• • 20-40 hours per week hours/week - must be available to reputed company on Tuesdays and Thursdays

Benefits

• Remote work
• Part-time schedule of 20–40 hours per week, as business needs dictate

reputed company

Company H1B Sponsorship