Director, Promotion Compliance

Job Description

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.

Job Description

• 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.

Qualifications

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

Preferred:

• 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.

Educational Qualifications

Required:

• Bachelor’s Degree and 6+ years of experience in promotional pharmaceutical compliance and product labeling

Preferred:

• MD, MS, PhD, or PharmD and 3+ years of experience in promotional compliance and product labeling in the pharmaceutical industry

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $179,721.00 - Maximum $268,755.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.

Company benefits: comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

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