OverviewResponsibilitiesThe Washington, D.C. office of Epstein Becker & Green, P.C. is seeking an attorney to work at the level of a junior associate to join its Health Care and Life Sciences Practice.
Candidates should have a minimum of two years of relevant health law experience, and experience in one or more of the following areas is preferred:
- Regulatory status and pathway analysis. Analyze and explain to clients whether and how FDA regulates a product.
- Health regulatory due diligence. Support private equity, strategic and lender clients on life sciences transactions.
- Commercial compliance for drug and device manufacturers. Advise on Anti-Kickback Statute and fraud and abuse issues in sponsored testing, patient support and assistance programs, expanded access, as well as advertising and promotion, scientific exchange, and compliance program design and training or the life sciences industry.
- Premarket and lifecycle support. Assist with Pre-Sub and Pre-IND strategy, 510(k), De Novo and 505(b)(2) pathway analysis, labeling and promotion, post-market reporting and recalls.
- Inspections and enforcement. Support clients through FDA inspections, Form 483s, warning and untitled letters, and remediation, and through related DOJ or OIG inquiries.
- State licensure compliance. Advise life sciences companies on state licensure requirements and coordinate with state boards of pharmacy on applications, inspections, and ongoing compliance.
- Contract negotiations. Draft, revise, and negotiate contracts for life sciences companies, including clinical trial agreements, contract manufacturing agreements, quality agreements, and distributor agreements.
- Policy tracking and thought leadership. Track FDA, CMS and OIG developments and turn them into client-specific analysis, client alerts, training and CLE materials, and comment letters.
- Cross-practice collaboration. Work with the firm's transactional, reimbursement and coverage, fraud and abuse, and privacy colleagues.
QualificationsThe range for this position is $210,000 - $260,000. It is not typical for offers to be made at or near the top of the range. Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and where applicable, licensure or certification obtained. Firm factors are also considered. In addition to the base salary and a generous employee benefits package, successful candidates are eligible to receive a discretionary bonus.
Pay RangeUSD $210,000.00 - USD $260,000.00 /Yr.
