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:

Responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching regulatory strategy and brand plan. The candidate must have a solid understanding of regulatory advertising and promotion regulations, having had direct responsibility in this area. The candidate will contribute to strategic planning for the department, and the departmental achievement of initiatives to meet goals and plan. He/she will manage assigned projects and develop individual and team performance within assigned franchise. The candidate will network and benchmarks outside of Pharmacyclics to provide for best practices and processes.

Key Accountabilities/Core Job Responsibilities:

• Leads the regulatory strategy for the assigned marketed and development compounds.
• Functions as Promotional Review Committee (PRC) Chair and ensures compliant, thorough and efficient review of promotional materials.
• Works collaboratively and obtains alignment with external partners on regulatory strategies as appropriate.
• Advises cross-functional teams on content and message consistency and best practices regarding planning and execution of marketing strategies.
• Assures that cross-functional advertising and promotion review teams are operating according to approved company processes and procedures.
• Reviews and evaluates industry environment (e.g., regulatory, legal, and political climate), and plans strategically for overall system of regulatory communications.
• Provides regulatory guidance regarding advertising and promotional materials, new campaigns and launch strategies
• Maintains current knowledge of codes of practice, regulations and guidances that impact advertising and promotion.
• Supports departmental and business strategies, quality initiatives, compliance with policies and procedures, and the implementation of improvement plans.
• Contributes to the evaluation of departmental needs and implements solutions to enhance and facilitate operations.
• Responsible for the training of regulatory staff, as required.
• Provides strategic input into comprehensive training program.
• Conducts reviews and approval of professional and direct to consumer advertising and promotion and provides comments to review teams.
• Works closely with RA labeling group regarding package insert changes to assure that promotional PI and important safety information are updated as appropriate.
• Negotiates/resolves the majority of decisions with Marketing, Medical, Legal, Public Affairs and Compliance counterparts.
• Collaborates and communicates effectively through all levels of management across multiple divisions and functions.
• Is recognized by organizational counterparts as a key company resource on pharmaceutical advertising and promotion.
• Constantly searches for out of the box solutions while maintaining quality and adherence to regulations.
• Balances business needs and risk assessments with creative decision-making abilities.
• Leads cross-functional/ multidisciplinary/therapeutic teams

Qualifications:

• Minimum Bachelor's Degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), is required
• Master's, Ph.D or Pharm D, advanced degree in medical, sciences or legal preferred
• Preferred experience : 10 years of pharmaceutical experience
• A minimum of 5 years advertising and promotion regulatory experience preferred but may consider medical/scientific affairs or strategic regulatory affairs experience with a minimum of 5 years direct advertising and promotion review experience.

#LI-SH07

Equal Opportunity Employer Minorities/Women/Veterans/Disabled