Expertise in all things FDA
Menu
Careers
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 to Mid-Level Associate With Healthcare Experience – junior to mid-level associate with two to five years of experience to its healthcare compliance team.
Candidate should have experience providing advice to life sciences clients (pharmaceutical, biotech, and device companies) on some or all of the following matters:
- Federal healthcare program antikickback statute and state equivalents
- False Claims Act
- PhRMA and/or AdvaMed Code compliance
- Government price reporting and discount programs
Strong verbal and writing skills are required. The ideal candidate will have prior law firm or in-house experience.
Candidates must be members of the DC Bar or eligible to waive in. Compensation is competitive and commensurate with experience. HPM is an equal opportunity employer.
Please send your curriculum vitae, transcript, and a writing sample to recruiting@hpm.com
HPM Seeks Associate Drug Development Attorney – 3rd to 6th year associate to our busy drug development team.
Our team of lawyers and regulatory experts assists clients with a wide variety of FDA regulatory issues arising in the pre-market arena for clients developing drugs and biologics. Types of matters include:
- Informing development and providing guidance on associated regulatory strategy from early-stage (Pre-IND) activities through obtaining marketing authorization;
- Writing and advising on materials for submission to FDA during the course of product development including meeting briefing books, requests for expedited programs, INDs/NDAs/BLAs, and responses to inquiries from the Agency;
- Assisting clients with regulatory issues arising during the planning and conduct of clinical trials, including clinical trial design and IRB-related matters;
- Meeting with FDA on behalf of clients as part of FDA-sponsor meetings at stages of development and in other interactions with the Agency;
- Conducting due diligence related to transactions and securities offerings for companies with drug and biologic products; and
- Representing clients in FDA’s formal dispute resolution process, including related to clinical holds and complete response actions.
Strong verbal and writing skills are required; candidates with a scientific degree or background are preferred.
The ideal candidate will have experience working at FDA, in regulated industry, or prior big firm experience, including working with clients on pre-market drug or biologic FDA regulatory issues.
Candidates must be members of the DC Bar or eligible to waive in.
The boutique, collaborative nature of our 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 recruiting@hpm.com
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.
FDA Law Blog
