Combination Product Manager, R&D
Norwich Pharmaceuticals Inc•Montville Township, NJ
•$130,000 - $140,000
About The Position
The Combination Product Manager, R&D, is responsible for the development of drug-device combination products using design control and risk management processes. This position will also participate in review of device development, due-diligence of new combination products and investigation of market complaints.
Requirements
- BS/MS in Engineering (Mechanical or Chemical) or equivalent with 5-7 years of industry experience in the development of combination products (drug & device).
- Previous work experience should involve developing combination products using design controls including product risk management.
- Strong written and verbal communication skills, specifically in technical writing and oral presentations.
- Capable of working independently based on regulatory requirements, and company goals.
Nice To Haves
- Two to three years of experience with the development of generic combination products is preferable.
- Experience in the preparation, review and/or update of DHF for combination products is desirable.
Responsibilities
- Design and development of combination products involving device and drug constituent parts using the design control process (in compliance with 21 CFR 820.30 and ISO 13485:2016 section 7.3).
- Preparation, review or update of Design History File (DHF) and risk management file (in compliance with ISO 14971:2019) for the combination products.
- Monitoring and review of device constituent part development at the third party design/development house(s) including design reviews and DHF documents review.
- Subject matter expert for the due diligence of combination products such as injectable pens, inhalation products, transdermal products, infusions, etc.
- Contribute to the update of commercial combination product design and/or risk files, as needed.
- Partner with Third Party Quality, Combination product to ensure Design History Files and Risk Management Files are complete and compliant.
- Support complaint management, pharmacovigilance, and operations to assess product risks and risk reviews.
- Keep abreast of regulatory, cGMP and QSR trends. Stay informed of FDA, EU and ICH Guidelines on drug-device combination products.
Benefits
- medical and prescription drug coverage (two PPO plans and an HDHP with Health Savings Account and employer contribution)
- dental
- vision
- flexible spending accounts
- retirement savings program
- long-term care coverage
- paid time off (176 hours per year, prorated to hire date) inclusive of sick time
- disability benefits
- life insurance
- a wellness program
- 13 company recognized paid holidays per year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
