IKCON PHARMA, INC, an affiliate of IKCON TECHNOLOGIES, INC provides innovative services & solutions to our clients who develop novel, modern medicines to improve the lives of patients globally. By utilizing digital technologies, we can transform how sponsors approach clinical development by improving the patient experience, enhancing clinical trial productivity, increasing the quality of data collected in trials, and incorporating valuable insights from multiple sources of data. We are currently looking for a Regulatory Promo Advertising with one of our clients in [South Plainfield, NJ If you are actively looking for opportunities, please send us your updated resume with your contact details. JOB TITLE REGULATORY PROMO ADVERTISING CITY South Plainfield STATE NJ TAX TERMS W2 EXPERIENCE 8+ YEARS INTERVIEW MODE TELEPHONIC / SKYPE JOB DESCRIPTION The Regulatory Affairs Principal Advertising and Promotion Consultant is primarily responsible for the daily support or management of regulatory requirements for one or more drug products, providing leadership on advertising and promotional materials, and developing and maintaining relationships with key client staff and regulatory bodies. RESPONSBILITIES
- Act as a key regulatory affairs expert within a client regulatory team, providing expertise on regulatory strategy, process, filing, best practices, etc. in conjunction with client leadership.
- Provide strategic and operational leadership for promotional, educational, and investigative communications.
- Review and evaluate materials submitted by client teams to ensure that the content, quality, and format comply with applicable laws, regulations, and client policy.
- Manage launch preparation of promotional material for one or more products.
- Provide support and guidance to regulatory teams on RA requirements for one or more drug products.
- Maintain knowledge of changing regulatory requirements and advise teams as appropriate.
- Represent the client regulatory affairs team in other client meetings or workstreams; provide support for ancillary projects.
- Perform other duties as assigned.
- Minimum experience: 6+ years pharmaceutical regulatory affairs experience
- Minimum education: Bachelor's degree (advanced degree in a science discipline preferred)