Pharmaceutical Counsel, Commercial
Pharmaceutical Counsel, Commercial
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$ 230000 - 260000
1 Vacancy
Job Description
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 Companys 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 $230000 - $260000. 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 employment opportunities based on valid job requirements without regard to race color religion sex (including pregnancy) 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 for protected veterans and individuals with disabilities in compliance with all federal state and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are in fact non-discriminatory.
If you are qualified individual with a disability or a disabled veteran you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling or by sending an email to .
Employment Type
Full-Time
