Pharmaceutical Counsel, Commercial

The Pharmaceutical Counsel will provide general legal advice and business counseling to the commercial and medical functions of the Company and facilitate and manage legal issues relating to the commercialization, life cycle management and communication of promotional and medical information regarding pharmaceutical products. 

Responsibilities 

• Provide substantive legal advice on all laws, regulations, industry standards, and rules regarding the commercialization of pharmaceutical products, including but not limited to the Food, Drug and Cosmetic Act, and implementing regulations promulgated by the FDA pertaining to drug labeling and the advertising and promotion of pharmaceutical products
• Counsel internal clients with respect to the communication of scientific and medical information regarding pharmaceutical products
• Review and advise company with respect to promotional materials, programs, and activities for compliance with applicable federal and state requirements on promotional advertising
• Participate as a core member of the US Review Committee (the “USRC”), along with Regulatory Affairs, Medical Affairs, and ad-hoc reviewers, to review and approve the Company’s advertising and promotional materials and certain training materials in accordance with the Company SOPs and applicable laws and regulations
• Participate as a core member of the Medical Review Committee (the “MRC”), along with Medical Affairs and Compliance, to review all medical activity concepts and medical communication materials in accordance with Company SOPs and applicable laws and regulations
• Participate as a member of the Labeling Review Committee (the “LRC”) to review and approve all product labeling
• Partner with corporate communications stakeholders to advise on and review corporate communications, both internal and external (g., press releases, bulletins, corporate communications to employees, newsletters and other digital communications), including on social media channels
• Provide substantive legal advice and guidance on a wide range of pharmaceutical industry topics including FDA regulatory law, anti-kickback and other “fraud and abuse” laws, federal health care programs, privacy laws (including HIPAA), the Prescription Drug Marketing Act, and other laws affecting the commercialization of pharmaceutical products
• Participate as an active member of the Legal Department and contribute to various Legal Department projects or legal issues as they arise
• Collaborate with colleagues from the Legal and Compliance departments to assess risk and counsel internal stakeholders
• Review and negotiate contracts as needed

Minimum Job Requirements

• B.A. or B.S. from a recognized college or university
• J.D. degree from an accredited law school and admitted to practice law and current license in at least one state
• 4 years of experience as a legal professional, and 2 years of recent and relevant experience dealing with advertising, promotion, and the commercialization of pharmaceutical products at a company or law firm
• Must live a commutable distance to US Corporate offices in Florham Park, NJ

Preferred Skills and Experience

• Excellent verbal and written communication skills
• Ability to actively participate in committee meetings and productively add value to discussions with various business stakeholders, and propose pragmatic solutions or alternatives in real time
• Ability to influence and counsel other business professionals and to interact with stakeholders at various levels through the Company
• Ability to recognize risk and the ability to think of workable strategies to mitigate such risk
• Must possess the ability to calibrate responses to risk
• Strong negotiations skills
• Must be a team player who is positive, collaborative and resourceful
• Ability to prioritize business needs and assignments

Essential Physical and Mental Requirements

• Ability to travel via automobile and/or airplane.
• Ability to view video display terminal images < 18” away from face for extended period of time – up to four (4) hours at a time.
• Ability to operate a computer keyboard and telephone.
• Ability to sit for extended periods of time – up to four (4) hours at a time.
• Ability to lift, tug, pull up to fifteen (15) pounds.

To be considered for this position, you must apply and meet the requirements of this opportunity.

We look forward to reviewing your resume & qualifications.

DISCLAIMER

The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.  

EEO 

Shionogi Inc. is an equal opportunity/affirmative action employer.

All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.

It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.