Director, Regulatory Affairs, Advertising and Promotion
Company: Pharmacyclics, LLC
Posted on: June 14, 2019
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
- Leads the regulatory strategy for the assigned marketed and
- Functions as Promotional Review Committee (PRC) Chair and
ensures compliant, thorough and efficient review of promotional
- 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
- Assures that cross-functional advertising and promotion review
teams are operating according to approved company processes and
- 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
- Provides strategic input into comprehensive training
- Conducts reviews and approval of professional and direct to
consumer advertising and promotion and provides comments to review
- 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
- Leads cross-functional/ multidisciplinary/therapeutic teams
- 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
- 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-SH23 Equal
Opportunity Employer Minorities/Women/Veterans/Disabled
Keywords: Pharmacyclics, LLC, Sunnyvale , Director, Regulatory Affairs, Advertising and Promotion, Executive , Sunnyvale, California
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