Pharmacyclics, LLC

Manager, Regulatory Systems

Location
Sunnyvale, CA, United States
Posted
Nov 21, 2018
Ref
2571
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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:

Provides business-centric support for deployed processes and supporting technologies across Regulatory Affairs.Working under the direction of the Regulatory Operations leader, this role will help coordinate and deliver appropriate business support to improve users' ability to assimilate process and technology within the context of their jobs and allows management insight into the daily operations of RA. This role will work alongside other Regulatory Affairs personnel, some of which may be in different geographic locations. The successful candidate will be self-directed with both project management and/or personnel management responsibilities.

Key Accountabilities/Core Job Responsibilities:

  • Provides business support for deployed applications (e.g. electronic Document Management System (eDMS), eCTD compilation, authoring tools), including help identifying and providing appropriate training, gaining access to applications, and obtaining access to appropriate application components in support of the user community.
  • Serves as the primary business lead on Regulatory systems projects including initial implementation, upgrade and emergency changes; Responsible for providing business justification for RA system change control as appropriate
  • Leads and/or collaborates to implement, support and train Regulatory and/or cross functional team on Regulatory process and systems
  • Creates executive level data summaries/dashboards and the ability to partner with executive level leaders across the organization. Triages and resolves business process questions within the context of deployed applications; closely collaborates with project team members, business SMEs, and IT partners to identify and deliver solutions.
  • Identifies, monitors, and summarizes support Service Level Agreements (SLAs); effectively uses this information to implement and measure continuous improvement across functions.
  • Manages vendor relationships in collaboration with cross functional partners to include negotiation and communication related to software/services selection, evaluation, and routine communication
  • Supports Business Process Owners in the gathering and reporting of business process metrics; identifies and helps implement continuous improvement initiatives that can positively impact business process metrics.
  • Possesses a working knowledge of product life-cycle, business processes, and regulations in one or more RA sub-functions and collaborates with project team members to gain deep understanding of existing, new, and revised processes and supporting technologies. Utilizes this understanding to provide and improve business support capabilities.
  • Knows and understands existing and upcoming process and technology initiatives to effectively scale and enhance existing business support capabilities.
  • Works well in a global and/or matrix team environment; interacts effectively across RA sub-functions and related organizations across the globe.
  • Leads and/or assists with other projects and activities as assigned by management to support the Regulatory Operations function, including submission compilation and publishing support.

Qualifications:

  • Knowledgeable in CTD/eCTD structure and requirements and firm understanding of submission requirements for US submission types (e.g. IND, PAS, NDA, PSUR, etc.)
  • Demonstrated project management experience to include excellent organizational, prioritization and planning skills.
  • Strong knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-Ins (e.g. ISIToolbox), electronic document management systems, eCTD publishing tools, eCTD validation and viewing tools
  • Demonstrated project management experience to include excellent organizational, prioritization and planning skills.
  • Strong communication skills, both oral and written
  • Experience working in a matrix environment
  • Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy

Education and Experience:

  • Bachelor's degree in relevant field (Business, Project Management, Computer Science, Information Management) with 5 years related experience required
  • Project Management Certification (PMP® and/or CAPM®) preferred
  • 5 years in Regulatory Operations specifically within Regulatory Systems support role within the biotechnology or pharmaceutical industry preferred
  • 5 years of staff management and/or project management experience is highly preferred

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