Ad Promo Regulatory Advisor Job at LanceSoft, Inc. in Lawrenceville

Overview

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

Veeva experience (user level)
Technical skills with communication skills
Min 5+ years of experience
Promo Material review experience is a must
Requirements

5+ years of regulatory ad promo review experience
3+ years of Oncology Ad Promo review preferred
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.

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