Corporate Counsel - Clinical Affairs

Job Summary

The Corporate Counsel is responsible for managing various legal matters pertaining to Terumo Americas Holding, Inc. and certain of its subsidiaries and affiliates (collectively “TAH”), including clinical and medical affairs, commercial operations, contracting, healthcare compliance, employment law, corporate governance and intellectual property matters. Additionally, the Corporate Counsel will work with VP & Deputy General Counsel – Legal to develop long and short-term plans pertaining to legal matters to best manage TAH’s legal activities and minimize the risk to the business. Provide legal support and advice to TAH management and various internal business functions.  Provides business with effective advice on company strategies and their implementation while ensuring adherence to state, federal, and international laws and regulations. Oversees reviewing, drafting, and negotiation of various commercial agreements. Will be responsible for protecting TAH against legal and compliance risks.

Job Details/Responsibilities

1. Prepares, drafts, reviews, negotiates and modifies a wide variety of commercial contracts and other documents with legal significance, including but not limited to clinical trial agreements, sales agreements, GPOs, procurement agreements, consulting agreements, business development agreements, clinical affairs agreements, and confidentiality agreements.
2. Identifies, researches and provides advice on complex legal and commercial compliance issues and develops resolutions to those issues.
3. Exercises considerable judgment in identification of risks and proposals of alternative solutions to mitigate risks involved in potential transactions.
4. Assist in the identification, delivery of advice on and resolution of highly complex legal and commercial compliance issues.
5. Assists on strategic transactions and other mission critical initiatives.
6. Identifies the need for, initiates and develops language for the implementation of legal or commercial compliance policies.
7. Assists in the preparation and maintenance of corporate records for various TAH entities worldwide.
8. Stays current on developments in applicable laws, regulations and industry codes of ethics and practices.
9. Oversee the selection, management and evaluation of all outside counsel.
10. Interprets laws, rulings and regulations for the company and recommends appropriate changes or actions.
11. Maintain compliance with all Quality System requirements by maintaining a strong working knowledge of assigned training requirements. Fully adhere to all applicable government regulations, international guidelines and Terumo’s policies at all times. Establish and promote a work environment amongst co-workers that supports compliance with the Quality System and Terumo’s policies.
12. Perform other job-related duties as assigned.

Knowledge, Skills and Abilities (KSA)

• Demonstrate understanding of market challenges, organizational scale requirements, and the legal processes needed to support a rapidly growing company.
• Strong communication skills, including written communications, presentations, rapport building, negotiating and influencing skills.
• Excellent team leadership and collaboration skills with internal clients, external collaborators or partners, and other stakeholders.
• Adept at the leadership and management of change with the ability to diagnose and solve problems, articulate a plan, and implement solutions.
• Basic understanding of FDA Regulations, the Sarbanes-Oxley Act, and knowledge of U.S. health care compliance and global anti-corruption and anti-bribery laws and regulations (e.g., FCPA, Stark and Anti-Kickback).
• Extensive knowledge and experience in clinical and medical affairs, contract law, health care law, intellectual property law including patent law and licensing, and employment law.  
• Broad knowledge of relevant laws and regulations, analytical ability, business savvy, and a balance of legal, compliance and operational experience. This team player must relate well to all levels of employees and external stakeholders.
• Knowledge of Word Processing, Spreadsheet, Database, and Internet software.

Qualifications/ Background Experiences

• Requires Juris Doctor from an accredited law school. Member of the bar in good standing; admission to New Jersey state bar preferred.
• Minimum 6 years’ of legal experience in a relevant law firm or corporate setting.
• Medical device, pharmaceutical, life science, or other healthcare related experience preferred.
• Experience managing and dealing effectively with a broad range of legal matters across the spectrum of clinical and medical affairs, commercial contracting, employment law, compliance programs, intellectual property, mergers and acquisitions, product liability and any and all laws and statutes related to the healthcare industry.
• Experience dealing with international organizations and the broad issues encountered while dealing with differences of opinion and approach to international business issues.