Pharmaceutical Counsel, Commercial

Overview

The Pharmaceutical Counsel, Commercial 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

• Collaborate with colleagues from the Legal and Compliance departments to assess risk and counsel internal stakeholders• Draft, review and negotiate new contracts, as needed; Review and interpret existing contracts to advise business partners on contract requirements in an effort to ensure timely performance by Shionogi and counterparties

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• 5+ years of experience as a legal professional, and 3+ 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. Office presence required 50% per month, at least 2-3 days per week.

Preferred Skills and Competencies• 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•Must be able to identify, assess and prioritize the issues of greatest materiality and risk, and to think creatively to construct strategies and develop compliant solutions to solve identified challenges.• Strong negotiations skills• Must be a team player who is positive, collaborative, and resourceful•Ability to handle and prioritize multiple assignments and maintain key deadlines through effective time management.

To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.

Additional Information

The base salary range for this full-time position is $230,000 - $260,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role. 

EEO

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for empl