Allergan Sr Mgr Regulatory Systems in Irvine, California
Sr Mgr Regulatory Systems
Irvine, California, United States at http://agn.referrals.selectminds.com/jobs/776/other-jobs-matching/location-only
Oct 05, 2016Post Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world’s fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
· Serves as the key IT advisor and point of contact for all levels within the Regulatory Affairs group to provide IT support for day to day critical regulatory application (e.g. publishing, archival, RIM, XEVMPD) support activities as well as engage in tactical and strategic planning for the regulatory systems they use.
· Serve as the IT lead to initiate and facilitate discussions with Regulatory Affairs users (and other internal/external groups as needed) to analyze, advise, plan and execute projects and initiatives to meet business needs.
Main Areas of Responsibilities
· Partner with the Regulatory Affairs group to understand regulatory affairs business processes, plans, challenges and actively seeks to identify ways to apply technology to address capability, compliance and efficiency related gaps within IT solutions.
· Supervise and manage the support of the existing Regulatory Affairs systems for the Submission Planning, Authoring, Assembly & Publishing, Archival, Transmission, Labeling and Registration management process area. Manage operational IT application support groups for global regulatory submission publishing operations, ensuring effective and on-time submissions.
· Supervise and manage technical and validation activities related to the implementation, deployment and production change control/support of Liquent Insight Manager / Publisher platform and related peripheral applications within the R&D Regulatory Affairs business area, while conforming to Allergan’s System Development Lifecycle and validation processes.
· Work closely with IT Services groups and third party vendors to ensure that technology platforms are adequately supported and solutions are implemented effectively to meet business needs and are aligned within the IT landscape.
· Develop, communicate, and execute on a business-aligned IT strategy and implementation to support M&A, and advance effectiveness of regulatory systems ensuring compliance to emerging regulatory standards (i.e. IDMP).
· Develop project proposals for new/existing system enhancements including business case, process analysis, scope, effort, cost, resource and timelines. Provide feedback to application vendor(s) by participating in customer advisory boards.
· Collaborate and provide input to Regulatory IT Operational and Project budgets.
· Manages the communications and functional working relationships between Information Technology and other departments within the organization.
· Assure compliance with all company policies and procedures, including safety rules and regulations. Manage and supervise staff and third party vendor resources to ensure high standards of work quality and productivity in accordance with the organization’s policies, procedures, and state, federal and local laws.
· Provide technical and strategic IT leadership to internal business customers, technical team members, and vendor resources.
· Monitor, direct, coordinate and prioritize the activities of assigned staff.
· Provide support, direction and coaching to subordinates in the areas of training, disciplinary action, problem resolution, and work assignment delegation
· Prepare reports for management on information systems plans, projects, performance and related matters.
· Minimum of 10 years of pharmaceutical experience in a Pharma R&D IT environment of which:
o Minimum of 5+ years of experience in a technical administration, support and information management within a Pharmaceutical Regulatory Affairs IT environment.
o Minimum of 3 years of experience in electronic document management.
· Knowledge of the requirements for electronic submissions to regulatory authorities, and preparation & submission of documents using regulatory and document management systems (e.g. Insight Publisher and Insight Manager, Validation tools, Documentum®, FirstDocs®). Knowledge of Regulatory Labeling processes and systems (e.g. Docuproof/Proofware)
· Extensive experience with maintenance and administration of Parexel Insight Platform, and associated Regulatory Publishing tools (ISI Toolbox, Insight Validator, Lorenz Validator) is highly preferred.
· Experience with change management including business process design/redesign, solution design, development, implementation and data integration of Regulatory systems.
· Experience with system validation documentation and testing requirements, methodologies, and processes, including IQ, OQ, and PQ, as well as unit, integration, system, and regression testing.
· Excellent communication skills to ensure decisions, priorities and relevant project information is shared across appropriate levels of staff regarding service requests, projects and initiatives
· Understanding of compliance and regulatory standards e.g. ICH, 21 CFR Part 11, SDLC, GxP validation guidelines as well as all Allergan policies, and procedures.
· Experience with managing and supervising staff and third party vendor resources to ensure high standards of work quality and productivity in accordance with current company policies, procedures and regulations
· Proven ability to respond immediately to support business and IT departmental requests, complaints and conflict situations as they arise by working within and across IT functions as needed and partnering with vendors where appropriate.
· Analyzing and troubleshooting problems; identifying solutions; and recommending and implementing methods, procedures and techniques for resolution.
· Directing, supervising, coordinating and delegating assignments, and reviewing the work of assigned department personnel.
· Administering personnel policies, practices and procedures; and assuring confidentiality of proprietary, financial and personnel information.
· Leadership, supervision, team building, and training practices and methods.
· Communicating clearly and concisely, both orally and in writing.
· Establishing and maintaining effective working relationships, motivating peers and staff.
· Master’s Degree and certifications ofParexel Insight Manager/Publisher tool usage and/or administration arepreferred.
BS/BA in Engineering, Computer Science or Life Sciences (or other quantitative related discipline).