Life Sciences Regulatory & Compliance Associate - Midlevel

Full-time

No

##Life Sciences Regulatory & Compliance Associate - Midlevel

Goodwin is seeking a highly qualified mid-level associate to join their Life Sciences Regulatory & Compliance Practice. The ideal candidate will have experience in the pharmaceutical, biotech, medtech, and diagnostic industries; have experience managing junior attorneys; and have previously provided regulatory and compliance support in connection with corporate transactions or capital markets matters.

**Qualifications**

- Outstanding academic credentials
- Comparable law firm experience or commensurate experience working at the FDA
- Excellent written and verbal communication skills
- Desire to learn from experienced lawyers
- Member of the California Bar or ability to waive-in to the California Bar

**Experience**

The successful candidate should have experience representing pharmaceutical, biologic, medtech, and diagnostics companies (and their investors) on development and commercialization matters and a working knowledge of these industries. Familiarity with CLIA and/or HIPAA would be a plus.

**Responsibilities**

The position will include day-to-day support of FDA compliance matters, regulatory counseling, and due diligence reviews of FDA-regulated M&A targets, IPO candidates, potential collaborators, and licensees, primarily in the drug, biologic, medical device, and diagnostic areas. This position would also be expected to provide support to healthcare regulatory & compliance matters, including support on corporate transactions and capital markets matters, healthcare compliance program development, and market access/coverage matters.

##Overview of the Life Sciences Regulatory & Compliance Practice at Goodwin

Goodwin’s Life Sciences Regulatory & Compliance Practice advises on every step in the medical product lifecycle, from idea conception and product development to commercialization and customer contracts. This includes advising on clinical trials, FDA approval and clearance, market access, coverage & reimbursement requirements, healthcare fraud & abuse and compliance, and more.

The team works closely and collaboratively with the firm’s corporate, licensing, patent, government investigations, and litigation teams to provide comprehensive regulatory and compliance advice. They provide a collegial, dynamic, fun, and collaborative team environment where candidates can learn and grow their skills in the life sciences regulatory and compliance field.

##Salary Information

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Pharmaceutical, Biotech, Medtech, Diagnostics, FDA approval and clearance, Market Access, Coverage & Reimbursement Requirements, Healthcare Fraud & Abuse and Compliance, CLIA, and HIPAA

Not Specified

Please click here to view salary information for this position.

Qualification and Experience Outstanding Academic Credentials, Comparable Law Firm Experience or Commensurate Experience Working At The FDA, Excellent Written and Verbal Communication Skills

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