Associate Director, Regulatory Affairs, Advertising and Promotion

Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.

More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.

General Position Summary/Purpose:

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.

Key Accountabilities/Core Job Responsibilities:

• Represents regulatory Affairs in the Promotional Review Committee (PRC) and actively participates in review of promotional materials applying regulatory and therapeutic area knowledge to Brand team's objectives and initiatives to develop solutions to complex US promotional isssues. Functions as Promotional Review Committee (PRC) Chair for assigned indications/setting and ensures compliant, thorough and efficient review of promotional materials
• Provides assessment of risks for marketing and medical campaigns
• Makes decisions and plans for day to day operations within area of responsibility with minimal supervision
• Maintains and evaluates productivity metrics
• Conducts reviews and approvals of Advertising and Promotional materials and provides comments to review teams
• Maintains effective communication channels with key Medical, Marketing, Regulatory, Legal and Public Affairs counterparts and assists in obtaining alignment among key stakeholders for issues.
• Identifies areas of improvement in process/policy, and develops recommendations/plan and leads initiatives.
• Collects and analyzes issues/trends that affect business to identify and act on cross-organization or cross business opportunities
• 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
• Possesses and leverages 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.
• Develops and delivers strategic presentations for senior management if required

Qualifications:

• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, nursing)
• Relevant Master's or Ph.D, or advanced scientific or law degree preferred
• Certification a plus
• 8 years in pharmaceutical industry experience with an emphasis on RA strategy, Medical Affairs 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 people management capacity preferred

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Equal Opportunity Employer Minorities/Women/Veterans/Disabled