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Senior Associate Attorney/Counsel, FDA
New York, NYTitle: Senior Associate/Counsel, FDA
Location: New York, NY, Pine Brook, NJ or fully remote
Schedule: Hybrid if located in NJ and/or NY area (3-days onsite/2-days WFH); Fully Remote if outside NJ/NY
Overview: A national boutique law firm established in 2000 is seeking a senior-level Associate or Counsel to join their FDA practice. The firm is focused exclusively on Healthcare and Life Sciences, and draws on its experience representing stakeholders across the entire healthcare spectrum. The firm has offices in Pine Brook, New Jersey, and New York City and are currently experiencing tremendous growth within their FDA practice.
Responsibilities:
Requirements:
Location: New York, NY, Pine Brook, NJ or fully remote
Schedule: Hybrid if located in NJ and/or NY area (3-days onsite/2-days WFH); Fully Remote if outside NJ/NY
Overview: A national boutique law firm established in 2000 is seeking a senior-level Associate or Counsel to join their FDA practice. The firm is focused exclusively on Healthcare and Life Sciences, and draws on its experience representing stakeholders across the entire healthcare spectrum. The firm has offices in Pine Brook, New Jersey, and New York City and are currently experiencing tremendous growth within their FDA practice.
Responsibilities:
- Compounding rules, regulations and FDA guidance
- 503A
- 503B
- Bulk API suppliers and re-packagers
- FDA audits/investigations
- Drug supply chain security and track and trace
- Trading partner requirements
- Unique trading partners (i.e., 3PLs, brokers, etc.)
- Serialization implementation requirements
- Other drug supply chain considerations
- Drug and device manufacturing rules
- CGMP compliance
- NDA and ANDA filings and evaluation
- 510K Premarket Approval Filings and evaluation
- OTC filings and evaluation
- Advice on manufacturing practices
- Clinical trial rules
- Structuring and drafting clinical trial agreements, informed consent forms, master service agreements, and related research contracts
- Institutional Review Board (IRB) submissions and compliance
- Clinical trial design, study initiation, data use, adverse event reporting, and post-trial obligations
- Labeling and advertising reviews
- FDA registration and annual filings
- FDA inspections, 483 responses and warning letters
- Drug withdrawals and recalls
- FDA importation and exportation rules
- Veterinary medicine and veterinary compounding
- Dietary supplements
- FDA regulated medical devices
- Reviews of clinical literature and incorporation into arguments/strategies (access to these clinical literature directories is a plus)
Requirements:
- 10+ years FDA experience – private law firm experience strongly preferred, but will also consider in-house candidates
- Clinical trial experience a plus
- Filing copyrights a plus
- Filing patents a plus
- May work in the Pine Brook or New York City office; will also consider fully remote arrangement if located in other states
- Admitted to practice in at least one US state
- Experience performing most/all of the job responsibilities of the position (outlined above)
- Team-player mindset, and ability to work cohesively and collaboratively with a team of attorneys
- Strong work ethic