Description:

Summary of Position:
The Senior Attorney, North America will report to the Vice President and General Counsel for North America, partner cross-functionally with the leaders across the business for North America.

Work Schedule: Monday – Friday 8am – 4:30pm

Essential Functions:

Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, DEA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
Establishing and implementing compliance policies and programs across the North American business segment to protect from legal risks and help lead training and implementation of compliance programs ranging from antikickback, pharmaceutical promotional review and interactions with healthcare providers.
Provide commercial contracting support for the North America procurement functions, including drafting and negotiating legal agreements with suppliers and service providers, including purchase and supply agreements, services and consulting agreements, confidentiality agreements, collaborative research agreements and material transfer agreements.
Review press releases, promotional materials and publications for potential legal risks including specifically the review of materials under applicable FDA regulation and guidance.
Provide legal guidance on compliance with various healthcare and competition laws such as anti-kickback, anti-trust, Health Insurance Portability and
Accountability Act (HIPAA), and Sunshine Act statutes and their associated regulations.
Coordinate with business management to plan and implement company initiatives and ensure appropriate management and ownership awareness of legal matters.
Support corporate-wide environmental, social and governance (“ESG”) initiatives.
Assist in drafting, updating, and implementing internal company guidelines and training materials regarding appropriate business conduct, ethics and contracting processes.
Advise on Government Price Reporting obligations, as well as ensuring pricing governance and pricing policies are followed.
Key points of work are reviewed with alternative courses of action, and unusual situations are presented to General Counsel for review.
Provide research, factual information, counsel, and guidance on legal questions or issues, reviewing with General Counsel. Assists in analysis of issues to identify legal problems.
Prepares memoranda and initial drafts of legal documents, examines documents for legal sufficiency. Negotiates and drafts documentation for various company transactions.
Receives assignments from General Counsel.

Requirements:

Juris Doctorate degree is required
5+ years of experience in a corporate or law firm setting with some experience preferably working with or in healthcare and pharmaceutical industries
Active membership and in good standing with a state bar association.
Significant experience in drafting, negotiating and providing counsel on transactional matters including commercial supply and service agreements, and licensing arrangements.
Experience in FDA regulatory, including drug advertising and promotion law is preferred.
Self-starter, energetic, positive, analytical, and able to drive results, and have a proven ability to work as part of a cross-functional team.
Exhibit the highest integrity, excellent judgment, and the ability to proactively recognize risks and challenges, devise strategies to address risks and
achieve goals, and effectively communicate about such issues with senior management, regionally and globally.
Ability to negotiate agreements and provide business-oriented solutions to complex problems.
Highly motivated and experienced in successfully handling multiple projects, often with short deadlines, and have the ability to work independently and prioritize responsibly with minimal supervision.
Exceptional written and verbal communication skills.

Working Conditions:

This position works in typical office conditions with extensive time using computer equipment.
May be required to sit or stand for long periods of time while performing duties.
Close attention to detail required.
Willingness to work in a team-based environment.
The position deals with many deadlines. Due to the short turnaround time of deadlines and limited time, overtime is sometimes required.
Must be able to work outside of regular work hours, including weekend, and holiday work as business needs require. 
May be required to sit or stand for long periods of 8+ hours a day while performing duties.

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.