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Join our teamHyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, is always looking for exceptional candidates with relevant substantive experience or background. Candidates must have prior work experience in the government (e.g., FDA, DEA, HHS, or DOJ) or in-house at a life sciences company; portable business is bonus, but not required. Ideal candidates will possess strong verbal and writing skills and a detailed understanding of the regulatory construct governing our life sciences clients. Candidates must be members of the DC Bar or eligible to waive in.
Expertise in all things FDA
Junior Associate
Hyman, Phelps & McNamara, P.C. (HP&M) seeks to add a 2nd to 3rd year associate to our strong and busy associate team. Our team assists clients with a wide variety of FDA regulatory topics across FDA-regulated products. Types of matters include:
- Developing regulatory strategy for obtaining marketing authorization
- Meeting with FDA on behalf of clients seeking marketing authorization and in other interactions with the Agency
- Advising on and developing policies for regulatory compliance matters including complaint handling, field actions, recalls, and promotional review
- Conducting internal investigations and audits
- Responding to government inspections and other compliance matters
- Conducting due diligence related to transactions and securities offerings
Strong verbal and writing skills are required. The ideal candidate will have experience working at FDA or prior big firm experience, including FDA regulatory law experience. Experience with medical device regulatory issues a plus.
The boutique, collaborative nature of this firm provides associate attorneys unique opportunities to work directly with clients and to contribute in substantive ways to sophisticated, high-end matters.
Compensation is competitive and commensurate with experience. HP&M is an equal opportunity employer. Please send your curriculum vitae, transcript, and a writing sample to Deborah Livornese (dlivornese@hpm.com).
Candidates must be members of the DC Bar or eligible to waive in.
Experienced Pricing Attorney
Hyman, Phelps & McNamara, P.C. (HP&M) seeks to add an experienced attorney (7+ years) to our government discount program and price reporting practice. Our ideal candidate will have significant substantive experience working with:
- Price calculation and reporting under the Medicaid Drug Rebate Program and the 340B Drug Discount Program
- Average sales price reporting under Medicare Part B
- Price reporting and contracting with the Department of Veterans Affairs
- Drug discounting requirements under the Inflation Reduction Act Medicare inflation rebate programs, maximum fair price negotiation program, and Part D manufacturer discount program
Experience in FDA and other regulatory issues affecting the pharmaceutical industry is a plus.
Our firm culture is collaborative, and the subject matter is intellectually stimulating. Strong verbal and writing skills are required. Partner/director, counsel and senior associate level attorneys with the requisite substantive experience are encouraged to apply. The ideal candidate will have a book of business.
Compensation is competitive and commensurate with experience. HP&M is an equal opportunity employer. Please send your curriculum vitae, transcript, and a writing sample to Deborah Livornese (dlivornese@hpm.com). Candidates must be members of the DC Bar or eligible to waive in.
The staff of Hyman, Phelps & McNamara, P.C., is a diverse and dedicated team who work together to provide outstanding support to the firm’s clients. We offer a collegial work environment where employees’ efforts are recognized and valued.
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