The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. Envisions the future by using global marketplace, technology and business knowledge. Collects and analyzes issues and trends that affect the business. Identifies and acts upon cross-organization or cross-business opportunities. Possesses and leverages broad industry knowledge.
- Make decisions and plans for operations (work flow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives.
- Maintains and evaluates productivity metrics to project current and future business needs
- Aligns and maintains effective communication channels with key Medical, Marketing, Regulatory, Legal and Public Affairs counterparts. Identifies areas of improvement in process/policy, develops recommendations/plan, and leads initiatives.
- Assists in the management of the departmental budget, identifies and communicates budgetary needs to Operations and Finance, and identifies and projects current and future expenditures and business needs.
- Collects and analyzes issues/trends that affect business to identify and act on cross-organization or cross business opportunities. Effective use of knowledge of global marketplace, technology and business levels.
- Operates independently, with recognition of when to consult departmental senior concerning risks. In absence of Director, is responsible for day-to-day operations. Responsible for departmental initiatives, which have significant impact on both internal and external customers.
- Encourages innovation and holds employees accountable for delivering on their goals; recognizes, mentors, rewards and recommends promotion for staff members based on their performance, results, and development.
- Exhibits solid understanding of regulations, and guidance of regulatory authorities, political and legal climate and industry practices related to advertising and promotions to assist in meeting organizational goals. Possesses and leverages broad industry knowledge
- Develops and implements complex processes and projects and develops and delivers strategic presentations for senior management
- Identifies areas of improvement in process, policy, develops recommendations/plan and leads initiatives
- Bachelor’s Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy)
- Relevant Master’s or Ph. D, or advanced scientific or law degree preferred
- Certification a plus
- 8 years industry related experience preferred
- 8 years in pharmaceutical experience with an emphasis on RA strategy or US Advertising and Promotion preferred.
- Experience working in a complex and matrix environment
- Strong communication skills, both oral and written
- Experience developing and implementing successful global regulatory strategies
- Experience in management capacity preferred
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Job Type: Experienced