Mallinckrodt Pharmaceuticals · 4 hours ago
Associate General Counsel, Advertising & Promotion / Clinical Development
Bridgewater, NJ
Full-time
Hybrid
Senior Level
$210K/yr - $280K/yr
5+ years expMallinckrodt Pharmaceuticals is seeking an experienced attorney with a strong background in pharmaceuticals for the role of Associate General Counsel, Advertising & Promotion / Clinical Development. The position involves providing legal and regulatory support for FDA promotional review activities and research & development initiatives while collaborating with cross-functional teams to ensure compliance with applicable laws and regulations.
Biotechnology
Responsibilities
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
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
Partner with Regulatory Affairs, Medical Affairs, Compliance and Commercial teams to align on compliant strategies
Monitor evolving FDA regulations and communicate implications to stakeholders
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
Provide other legal advice and support as necessary to fulfill the Company’s strategy and mission
Qualification
Required
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
Preferred
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
Benefits
Competitive pay and benefits
This position is eligible for a bonus in accordance with the terms of the applicable program.
Company
Mallinckrodt Pharmaceuticals
Mallinckrodt Pharmaceuticals combined with Endo in 2025 to better serve customers and improve outcomes for the patients we support.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2013-07-01IPO
Leadership Team
Paul O'Neill
SVP Quality and Operations, Specialty Brands
Ryan Magee
Global Device Engineering Director of Validation and Engineering Services
Recent News
2025-11-12
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