Associate General Counsel, Advertising & Promotion / Clinical Development

Mallinckrodt Pharmaceuticals•Bridgewater, NJ

About The Position

Position Summary : We are seeking an experienced attorney with a strong background in pharmaceuticals to provide legal and regulatory support for FDA promotional review activities and research & development initiatives. This role will partner closely with cross-functional teams—including R&D (Regulatory Affairs, Medical Affairs, etc.), Commercial and Compliance—to ensure compliance with applicable laws, regulations, and industry standards governing pharmaceutical advertising, promotion, and clinical development. This role will work collaboratively with the commercial attorneys and the entire legal group.

Requirements

JD from an accredited law school; admission to a U.S. state bar and ability to gain entry into the New Jersey state bar.
5+ years of legal experience in pharmaceuticals and/or biotechnology or in a major U.S. law firm healthcare or FDA practice.
Strong knowledge of FDA regulations and promotional review processes

Nice To Haves

Excellent written and oral communication, analytical and collaboration skills.
Strong negotiation and dispute resolution capabilities with an eye toward resolving professional disagreements amicably and compliantly.

Responsibilities

Promotional Review: Advise on FDA regulations, guidance, and enforcement trends related to advertising and promotional materials for prescription drugs, medical devices and biologics.
Serve as legal reviewer on promotional review committees for marketing, sales, and medical communications.
Ensure promotional materials comply with FDA, FTC, and other applicable requirements, as well as company policies.
Research & Development Support: Provide legal counsel on clinical trial agreements, investigator-initiated studies, and collaborations with academic institutions.
Advise on regulatory and compliance issues related to clinical development, labeling, and product lifecycle management.
Support risk assessments and mitigation strategies for R&D activities.
Cross-Functional Collaboration: Partner with Regulatory Affairs, Medical Affairs, Compliance and Commercial teams to align on compliant strategies.
Monitor evolving FDA regulations and communicate implications to stakeholders.
Governance & Training: Develop and deliver training on FDA promotional regulations and compliance best practices.
Assist in drafting and updating internal policies and SOPs related to promotional review and R&D legal support.
General Legal Support Provide other legal advice and support as necessary to fulfill the Company’s strategy and mission.