职位描述
职位描述：
Janssen R&D Information Technology is recruiting an IT Manager, Janssen R&D, Quantitative Sciences . This position can be located in Shanghai, 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 Quantitative Sciences. This position will be dotted line and closely aligned with the Global Janssen R&D Quantitative Sciences Team.
This position is part of a team supporting Janssen R&D Quantitative Sciences with primary responsibility for Clinical Pharmacology, Biostats, Medical Writing. Data Management and Model Based Drug Design. The role focuses primarily on the development of clinical development capabilities in China, whilst ensuring maximum leverage out of the existing capabilities in Janssen R&D. S/he will be responsible for all aspects of project, program and portfolio management including establishing scope and project objectives, elicitation and capture of business requirements, achieving project objectives, ensuring effective integration of new systems and technologies in existing system landscape, meeting time and budget requirements, directing all project resources, and helping the business partner(s) realize the desired business goals for the project(s).
Responsibilities include:
? Serves as an expert resource supporting one or more areas, processes, or technologies in Quantitative Sciences.
? Leads large, moderate to complex projects, programs or initiatives. Manages business partner expectations at a senior level, resolving conflicts between requirements, timelines and budgets.
? Identifies and manages risk and issues at the project and program level.
? Negotiates the needs of multiple users or business partners.
? Works independently in formulating innovative ideas and solutions on products, processes, and systems. Assesses proposed solutions and develops recommendations based on industry trends and benchmarking always in alignment with IT strategies and technology roadmaps. Contributes to the business case development for proposed projects.
? Builds and maintains strong partnerships with strategic technology providers. Manages vendors necessary to complete projects.
? Contributes to the documentation and visual representation of the end-to-end view of process, systems and data flows.
? Proposes improvements to IT systems/services and business processes enabled through technology. Contributes to the development of technology roadmaps.
? 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 knowledge and experience working with systems for the support of Quantitative Sciences including the following areas:
? Biometrics/Biostatistics: familiar with one or more programming languages/environments, including SAS/SAS DD, R, SPlus and the management of functions/libraries/tools at the enterprise level. Strong understanding of infrastructure and processes required for enterprise wide statistical data management. Knowledge of clinical trial protocol design and clinical development statistics methods preferred.
? Clinical pharmacology and Model-based Drug Development: familiarity with support of one or more modeling and simulation tools and environments: Pharsight Knowledge Server, WinNonlin, PBPK tools, Matlab
? Medical Writing: familiarity with structured content authoring tools and environments preferred. Strong knowledge of medical and regulatory document construction and submissions processes.
? Electronic data capture systems to support clinical trials.
? Excellent understanding of the external landscape with regards to running clinical trials in China.
? Successful project delivery experience.
? Broad technology experience with ability to lead assessments of proposed solutions and develop recommendations. Understanding of the business impact of different solutions and ability to assess impact and communicate the tradeoffs between business needs, technology requirements, timelines, costs and risks.
? Understanding of departmental budgets and the ability to allocate resources accordingly.
? Thorough understanding of SDLC including requirements elicitation, system design, development and validation and regulatory requirements.
? Strong communication and interdependent partnering skills in global setting
? 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.
? Typical candidates will possess 8+ years of relevant experience and BA/BS degree or equivalent OR 6+ years with advanced degree or equivalent. Experience leading large, moderate to complex projects, programs, or initiatives across franchises or enterprises is required. Project management certifications are preferred. Understanding Biometrics/Biostatistics with one or more programming languages/environments, including SAS/SAS DD, R, SPlus and the management of functions/libraries/tools at the enterprise level is preferred. Strong understanding of infrastructure and processes required for enterprise wide statistical data management is preferred. Knowledge of clinical trial protocol design and clinical development statistics methods preferred. Within Clinical pharmacology and Model-based Drug Development, familiarity with support of one or more modeling and simulation tools and environments: Pharsight Knowledge Server, WinNonlin, PBPK tools, Matlab in preferred; Medical Writing familiarity with structured content authoring tools and environments preferred including strong knowledge of medical and regulatory document construction and submissions processes; knowledge of Electronic data capture systems to support clinical trials is preferred. Excellent communication, collaboration and relationship building skills are required.
