This Senior Pharmaceutical Counsel will utilize their scientific, legal, compliance and regulatory knowledge to provide legal advice, and facilitate and manage the legal issues relating to the commercialization and communication of medical communication of pharmaceutical products. This Senior Pharmaceutical Counsel reports directly to Shionogi Inc.s General Counsel.
Provide legal advice on all laws, regulations, 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.
Provide counseling 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 all of the Companys advertising and promotional materials in accordance with Company SOPs and applicable laws and regulations.
Participate as a core member of the Medical Review Committee (the MRC), 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.
Provide counseling with respect to corporate communications, both externally and internally (g., press releases, bulletins, newsletters, and other digital communications).
Provide substantive legal advice and services 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.
Review and negotiate contractual agreements relating to services pertaining to the commercial division of the company.
Minimal domestic travel annually.
B.A. or B.S. from a recognized college or university. Life Science major is a plus.
JD degree from an accredited law school and admitted to practice law in at least one state.
6 years of experience as a legal professional, which should include 3 years of recent and relevant experience dealing with advertising, promotion, and commercialization of products at a pharmaceutical company or law firm.
Excellent verbal and written communication skills.
Ability to actively participate in committee meetings and productively add value to group dynamic and group discussion and propose pragmatic solutions or alternatives in real time.
Ability to influence and counsel other business professionals.
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.
Strong strategic thinking skills and ability to translate strategy into an effective action plan.
Must be a team player who is collaborative and resourceful.
Ability to travel via automobile, train and/or airplane.
To be considered for this position, you must apply and meet the requirements of this opportunity.
We look forward to reviewing your resume & qualifications.
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 responsibilitiesmay change or be assigned at any time with or without notice.
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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)
Equal Opportunity Employer-minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity