We are seeking an experienced attorney to join our whip-smart and highly respected Legal and Compliance Department at the company’s world headquarters in Boston, MA. The Department is committed to a trusting and collaborative culture where we value growth and development. We engage proactively with our business colleagues to truly understand them and to deliver results for our company and for patients. If you thrive in a fast-paced, hands-on, and team-oriented environment where you can have a big impact on the organization, we’d love to talk to you!
The individual in this position will provide solutions-oriented legal advice to a broad spectrum of internal clients from the following functions: Regulatory Strategy, Regulatory Policy, Safety, Quality, Clinical Development, Clinical Trial Transparency, Publications, Managed Access, and Global Marketing. This position will report to the Head of FDA Regulatory Legal.
- Advise cross-functional project teams on regulatory law issues related to pipeline products (e.g., investigator meetings, GCP issues, IND safety reporting, IRB issues, development plans, subject recruitment)
- Provide solutions-oriented and strategic advice relating to the company’s interactions with FDA, including crafting legal arguments for inclusion in regulatory submissions and helping teams prepare for formal meetings with FDA and advisory committee meetings
- Advise on issues related to FDA’s expedited programs for serious conditions, such as accelerated approval, fast track designation, breakthrough designation, priority review, as well as on exclusivity issues
- Assist Quality organization in preparing for audits and inspections by regulatory authorities, responding to FDA Form 483s and warning letters, developing remediation work plans, and conducting market withdrawal/recall/field action analyses
- Advise on legal questions relating to sunshine reporting and clinical trial transparency initiatives (e.g., ct.gov and EudraCT requirements, researcher requests for clinical trial data, Policy 0070, provision of plain language summaries under EU Clinical Trial Regulation)
- Provide regulatory support for transactions, including conducting regulatory due diligence, negotiating key regulatory terms and supporting post-transaction integration activities
- Participate in various Legal & Compliance Department projects and initiatives (e.g., Culture Committee, Pro Bono & Community Engagement Committee, Talent & Development Committee, Diversity Committee, offsite planning, strategic planning).
- JD from an ABA accredited law school and member of a state bar.
- Minimum of 7 years’ experience providing FDA regulatory advice to pharmaceutical, biotechnology, or medical device companies, whether in-house or at a law firm with a nationally recognized FDA life sciences practice
- Specific expertise required in statutes, regulations and guidance concerning: GxP, drug development, regulatory submission standards, expedited programs for serious conditions, promotion and scientific exchange, Hatch-Waxman, compassionate use, Orphan Drug Act, and DQSA.
- Solid working knowledge of other laws, regulations, and industry standards that affect the development and commercialization of pharmaceutical and biotechnology products, including AKS, FCPA, OIG guidelines and opinions; clinical trial reporting laws, Sunshine Act/transparency laws; privacy laws, product liability, and industry standards (e.g., PhRMA guidelines, ICMJE and GPP standards, ACCME guidelines).
- Team player with excellent judgment and interpersonal skills
- Ability to constructively counsel and influence clients in making the right decisions
- Capacity to simultaneously handle a variety of complex legal matters with minimal guidance
Demonstrable experience taking ownership of issues and providing practical advice