Sr. Manager, 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 Sr. Manager, Regulatory Affairs Advertising and Promotion provides regulatory guidance in the development of compliant advertising and promotional materials, disease state education, field training materials, and external communications including the development of new launch materials/new claims as appropriate. Evaluates materials to ensure compliance with FDA regulations, guidance, and Pharmacyclics corporate policies. Conducts a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims, assesses consistency of proposed claims with FDA approved labeling and delivers consistent, well-supported, and clear guidance.
This position must be capable of representing the commercial regulatory perspective at and chairing the promotional review committee (PRC). This position requires an ability to understand and evaluate competing perspectives and provide clear regulatory guidance.
Provide regulatory guidance regarding advertising and promotional materials, new campaigns and launch strategies for company products.
Lead the Promotional Review Committee (PRC), Clinical Medical Review Committee (CMRC) and Corporate Communications Review Committee (CCRC) as assigned.
Participate actively in Ad Promo review meetings and collaborate with other reviewers to determine next steps and approval status.
Complete timely, accurate review of advertising and promotional materials
Maintain a thorough understanding of OPDP requirements as well as a keen awareness of enforcement trends. Communicate significant changes or other relevant matters to internal partners and stakeholders
Proactively identify and address compliance issues
Work collaboratively with colleagues in the Regulatory Affairs, Medical, Legal, and Commercial organizations to impact marketing strategies, implementation and promotion goals
Provide assessment of risk for marketing and medical campaigns.
Advise Materials Approval and Review Committees (MARC) Operations Management (MOM) and/or Regulatory Operations group regarding requirements for FDA 2253 submissions.
Provide the commercial regulatory perspective and rationale at regulatory project team meetings, brand team meetings and, as needed, providing training to product manager counterparts in marketing and members of the PRC.Ensures that changes to USPI are appropriately implemented and reflected in current promotions.
Coaches and mentors junior staff within the department
Provide training in FDA regulations for advertising and promotion to internal staff.
- Bachelor's degree (life sciences preferred)
- Graduate degree Strongly preferred (MS, PharmD, PhD)
- 7-10 years of pharmaceutical industry experience, including 5 years in regulatory affairs with 3 year in Advertising and Promotions.
- Deep and broad knowledge of FDA regulations and guidelines.
Excellent verbal and written skills. Effectively communicates difficult and complex issues in a way that accurately and persuasively
identifies the issues to be resolved to internal and external stakeholders.
Good influencing and negotiation skills: demonstrated ability to lead diverse teams and affect stakeholders of varying organizational levels without direct authority
Strong Leadership skills and problem-solving skills
Strong interpersonal skills with the ability to influence within a cross-functional team or partnership environment in a positive, effective and professional manner.
Skilled in conflict resolution and negotiation. Fosters open communication. Listens and facilitates discussion and resolution. Able to make ethical and compliant decisions.
Strong organizational and prioritization skills
Experience in commercial regulatory and advertising promotion preferred.
RAC , PharmD or Lawyer desirable