Senior Counsel -US Rare Tumors

EMD Serono•Boston, MA

About The Position

The Senior Counsel, Rare Tumors will provide comprehensive legal support to a Therapeutic Area, including both Commercial and Medical functions. Specifically, this role will be part of the legal team supporting Rare Tumors, one of EMD Serono’s key Therapeutic Areas, and will report to an Associate General Counsel. The role requires a deep understanding of healthcare laws and regulations applicable to pharmaceutical commercialization, including the Anti-Kickback Statute, False Claims Act, FDA promotional regulations, OIG guidance, and laws governing patient support and affordability programs. The ideal candidate will be a proactive, collaborative legal partner who enables business goals while ensuring compliance with ethical standards.

Requirements

Juris Doctor (JD) degree from an accredited U.S. law school.
Active bar membership in good standing in at least one U.S. jurisdiction.
7-10 years of legal experience in a firm and/or in-house.
Strong ability to interpret and apply laws, regulations, and guidance in a practical, business-oriented manner.
Excellent communication, drafting, and negotiation skills.
Proven ability to work collaboratively across multiple functions in dynamic and fast-paced environment.

Nice To Haves

Prior in-house experience at a pharmaceutical or biotechnology company.
Demonstrated expertise in healthcare fraud and abuse laws, FDA regulatory matters, and patient support program compliance.
Experience supporting commercial business units, including contracting, supporting the development of commercial strategies.
Experience participating in or advising MLR/Promotional Review Committees.
Background in compliance counseling or interaction with government agencies (OIG, DOJ, FDA).

Responsibilities

Serve as lead attorney for a key brand of the Rare Tumors Therapeutic area, including: review of marketing (promotional) materials; advice regarding Marketing and Sales Operations; review of scientific (non-promotional) materials; advice regarding Medical Affairs and Medical Operations; manage outside counsel as specialized advice is required for Therapeutic Area projects; work collaboratively with paralegals.
Ensure all activities comply with FDA, OIG, CMS, and state requirements, as well as company policies and industry codes (e.g., PhRMA Code).
Draft, review, and negotiate agreements with advertising, consulting, call center and Therapeutic Area-specific distribution agreements, as well as contracting with healthcare professionals including advisory boards and consulting.
Deliver legal training on relevant healthcare laws and company compliance requirements.
Partner closely with Commercial, Compliance, Medical Affairs, and Regulatory teams to align business practices with legal standards. Collaborate with US and Global colleagues in order to ensure business strategies and objectives comply with applicable laws, regulations and policies.
Proactively identify, counsel, and communicate potential legal issues to mitigate risk. Manage risks through counseling, training and practical application of relevant legal and regulatory requirements, Company policies and procedures to Therapeutic Area operations.