Manager, Regulatory Affairs Advertising & Promotional Materials
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:
Materials Process Manager for the Materials Approval and Review Committee (MARC).
A Regulatory project management position serving as the primary point of contact for the review and approval process of materials used to communicate about the company and its products.
Key Accountabilities/Core Job Responsibilities:
- Ensure that projects are completed on schedule following established procedures and timelines
- Schedule and facilitate MARC meetings serving as the single point of contact for MARC meeting coordination
- Collaborate with marketing and medical education groups on strategies for new promotional materials
- Team with business unit Specialists to share best practices related to advertising and promotion and drive consistency across reviewers.
- Ensure consistency across functions for coordination of submissions, categorizing review types and prioritizing materials for review
- Document required changes and comments during materials review meetings and communicate final approvals
- Ensure active materials are reviewed annually or get retired
- Participate in implementation of relevant software systems related to Materials Review and perform User Acceptance Testing
- Train materials sponsors, reviewers and outside vendors on the MARC process and system
- Supports strategic planning, MARC development, workflow modifications, and updating operations guidelines and SOP's
- Monitor daily operations and adherence to SOP's
- Track, monitor and report non-conformances
- Track and report MARC performance metrics
- 5+ years biotech or pharmaceutical industry experience preferred.
- Demonstrated excellence in project management and effectively managing multiple projects/priorities
- Strong, open and transparent communication skills (verbal and written)
- Strong computer skills - experience with : MS Office and document management systems
Education (degree, certifications, etc.):
- Bachelor's degree in business or biological sciences preferred