Directs or assists staff member(s) and independently reviews and approves content and required of promotional labeling materials for prescription drug and medical device products. Ensures that promotional labeling and training material meet regulatory and company requirements. The candidate must demonstrate a high level of understanding of promotion compliance and labeling. May be assigned additional responsibilities as deemed necessary.
- Supervises direct and/or indirect report(s) or acts to ensure all promotional and labeling materials are in compliance with relevant laws and regulations. Analyses and interprets new regulations and Guidance document as well as monitors and determines the impact of Office of Prescription Drug Promotion (OPDP) correspondence and enforcement actions.
- Supervises direct and/or indirect report(s) or participates in the development, maintenance, and approval of promotional labeling components, and provides strategic advice in labeling meetings for development of promotional messages
- Supervises direct and/or indirect report(s) or reviews promotional and commercial communication materials to ensure that the information conveyed is consistent with the product labeling and is suitable for their intended audience and use.
- Responsible for final review and approval of promotional and sales training materials, and corporate communications, and corporate communications as needed, as appropriate.
- Ensures product promotional materials are submitted to OPDP on Form FDA 2253 in a timely manner as per regulations, and that materials are archived as per company policy.
- Monitors and informs others of changes in US labeling and promotional regulations as well as corporate policies and procedures, as appropriate. Utilizes these changes in developing and modifying company procedures.
- Manages contracts for contractors and consultants.
- Attends cross functional teams: Global Regulatory Team (GRT), Global Labeling Team (GLT).
- Provides training to OAPI/OPDC employees and affiliates on regulations for promotion compliance, as appropriate.
- Acts as liaison between the company and OPDP. Arranges and leads meetings with OPDP as appropriate.
Knowledge/ Experience and Skills:Required:
- Solid understanding of US regulatory requirements
- Broad knowledge of clinical medicine and clinical pharmacology
- Excellent understanding of medical concepts and terminology
- Solid understanding of the structure and function of the product labeling
- Fundamental understanding of the pharmaceutical industry drug development process
- Able to work across multifunctional groups
- Strong written and oral communication skills
- Strong computer skills including experience with MS Office: Word, Excel, PowerPoint, Veeva PromoMats, CREDO, Outlook, Teams, and Adobe Acrobat
- The ideal candidate should be action oriented, customer focused, and have the ability to manage workloads, set priorities, demonstrate managerial courage to build effective teams. In addition, the candidate should be capable of dealing with ambiguity, be creative, be comfortable working with multifunctional teams, and show strong business acumen.
- Bachelor's Degree and 6+ years of experience in promotional pharmaceutical compliance and product labeling
- MD, MS, PhD, or PharmD and 3+ years of experience in promotional compliance and product labeling in the pharmaceutical industry
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.Disclaimer:
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
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