Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) discovers and develops new compounds that address unmet medical needs and advance human health. OPDC has numerous compounds in development to treat disorders in the neuroscience, oncologic, and cardio-renal therapeutic areas. OPDC is part of the Otsuka Group companies. For more information, visit www.otsuka-us.com.
May be assigned additional resposibilities as deemed necessary.
Supervises direct and indirect report(s) or acts to ensure all promotional materials are in compliance with relevant laws and regulations. Analyses and interprets new regulations and Guidances as well as monitors and determines the impact of Office of Prescription Drug Promotion (OPDP) correspondence and WARNING Letters.
Supervises direct and indirect report(s) and/or participates in the development and maintenance of promotional labeling components, and provides strategic advice in labeling meetings for development of promotional messages, and implementation of new regulations.
Supervises direct and 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. Provides alternative suggestions to allow for consistent messaging.
Responsible for final review and approval of promotional and sales training materials, and corporate communications as appropriate. Ensures product promotional materials are submitted to DDMAC 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.
Recommends improvements to labeling policies, processes, quality, and system tools. Manages contracts for contractors and consultants.
Attends and participates in cross functional teams meetings including: Global Regulatory Team (GRT) and Global Labeling Team (GLT).
Provides training to OAPI/OPDC employees on regulations for promotion compliance as appropriate.
Acts as liaison between the company and OPDP. Arranges and leads meetings with OPDP as appropriate.
Bachelor’s Degree and 6+ years of experience in promotional pharmaceutical compliance and product labeling
The ideal candidate should be action oriented, customer focused, can manage workloads, set priorities, and have demonstrated the ability to build effective teams. In addition, he/she should can deal with ambiguity, be creative, be comfortable working with multifunctional teams and show strong business acumen.