Job Title: Ad Promo Regulatory Advisor
Location: 50% onsite Lawrence Township, NJ 08648
Duration: 6 Months
Duration: Initial 06 months (with possibility to extend up to 2 years)
Willing to consider self-relocation candidate
Top Technical skills
- Oncology experience
- Veeva experience (It should be user level)
- Technical skills with Communication skills
- Min 5+ years of experience
- Promo Material review experience is must
Requirements:
- 5+ years of regulatory ad promo review experience
- 3+ years of Oncology Ad Promo review preferred
- Veeva experience required
- 3+ years with MS Office 365
- Advanced practice degree required (PharmD, JD)
Day to day activities:
- Need to work cross functional
- Candidate will be supporting oncology business; candidates are expected to have a good understanding of US laws implementing medicinal usage.
- They will also be required to review material offline, however certain materials would be reviewed online with senior authorities and medical representatives.
Key Responsibilities
- Regulatory Review & Strategic Guidance: Provide expert regulatory advice and risk assessments on a broad range of advertising and promotional materials, sales training content, and external communications for assigned marketed products.
- Compliance Assurance: Ensure all promotional activities adhere to FDA regulations, approved product labeling, OPDP advisory comments, and relevant guidance documents. Partner with internal teams to proactively identify and mitigate regulatory risks.
- Regulatory Intelligence: Maintain current knowledge of U.S. federal and state laws, regulations, enforcement trends, and policy developments affecting pharmaceutical advertising and promotion. Translate regulatory changes into practical business guidance.
- OPDP Submission Management: Prepare and submit promotional materials to FDA’s Office of Prescription Drug Promotion (OPDP) on Form FDA 2253, ensuring accuracy, completeness, and timeliness.
- Labeling Alignment: Collaborate with cross-functional partners and management teams to ensure updates to U.S. Prescribing Information are consistently reflected across all promotional materials and campaigns.