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? Janssen R&D Information Technology is recruiting an IT Manager, Janssen R&D, Regulatory and Safety. This position can be located in Shanghai, China or Beijing, China.
? This position will deliver against Janssen R&D China and Enterprise business strategy as we build, advance and deliver on our pipeline through the strategic use of information technology in Regulatory and Safety. This position will be dotted line and closely aligned with the Global Janssen R&D Regulatory and Safety Team.
? The role represents expertise in the organization in the discipline of project, program and portfolio management. Roles in this sub-function are accountable for achieving project objectives, ensuring effective integration of new systems and technologies, meeting time and budget requirements, directing all project resources, and helping the business partner(s) realize the desired business goals for the project(s).This role will assume responsibility and direct accountability for the delivery of various components essential for the success of Regulatory and Safety information management within Janssen R&D China. In addition, this role will have cross-sector responsibility as we drive the OneChina Strategy. These components include the Product & Lifecycle Registration System, the Submission Planning, Tracking, and Processing utilities, as well as the future state Document Management System. The incumbent will be expected to possess a clear understanding of integrated, platform technology and work closely with external service providers to ensure delivery of solutions.
? Responsibilities include: Possesses a clear grasp of current Regulatory and Safety trends in information management and has a perspective on the future direction of the industry through relationships with vendors, industry peers, and internal business partners and stakeholders; Leads large, moderate to complex projects, programs, or initiatives across the franchise or enterprise (central, regional, and local affiliates, as well as cross-sector), including a GxP environment; Builds and manages strong relationships across all IT, legal, finance, and the impacted Business IT areas, etc.; Works effectively as part of a team; Operates effectively in a global environment; Solves complex or unusual problems in consideration of the potential impacts; Negotiates the needs of multiple users or business partners and can adapt to organizational and system complexity and ambiguity; Provides an effective balance between IT standards and strategies and business needs to guide well-informed decisions; Applies compliance requirements within scope of responsibility, provides documentation as necessary, and participates in compliance activities as required.
? Knowledge for this position should include: Deep understanding of current Regulatory and Safety technologies and processes associated with conducting regulatory specific activities; In-depth knowledge of all areas of IT and the resources available to deliver projects, programs or manage portfolios; Strong understanding of the current and future state technology and applications within the Regulatory Information Management (RIM) platform; Advanced knowledge of the strategic plans/initiatives of the Global Regulatory Affairs and Safety functions or work process area; Knowledge within the Master Data Management (MDM) domain and understanding the importance and framework of effective data governance and stewardship; Understanding of industry defined data standards and associated formats (i.e. EVMPD, IDMP, eCTD, etc.); Understanding of industry defined data standards and associated formats supporting the Adverse Event processing and reporting workflow for electronic transmission of individual safety reports (ICSR and E2B). Understanding of the business impact of different solutions, and the ability to assess and communicate the tradeoffs between business needs, technology requirements, costs, and risk; Understanding of departmental budgets and the ability to allocate resources accordingly; Understanding of the company’s strategic vision and future products, services, and strategies globally; Ability to identify and recover any troubled projects, programs and/or streamline a portfolio.
? Supervision Received/Provided: Functions very independently, receiving high-level and/or strategic guidance; able to self-direct, plan and execute initiatives (projects, programs, strategies); Manages business partner expectations at a senior level, resolving conflicts between requirements and budgets; Works independently in formulating innovative ideas and solutions on products, processes, and systems; Provides leadership, mentorship, or guidance to others; Manage vendors necessary to complete a project.
