Regulatory Affairs IT Project Manager

Job Category: IT/Software Development Company: Baxter Healthcare Reference Code: 33901BR Regulatory Affairs IT Project Manager Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives. Baxter Healthcare is seeking a senior Information Technology professional to define, maintain and manage projects in support of the Regulatory Affairs (RA) department. They will deploy global enterprise RA applications within a matrixed environment. This leadership position requires an individual who has significant experience in partnering with other IT teams to understand business requirements and deploying solutions that bring rapid value to the RA customer community. The incumbent must be "bi-lingual" in both technology and the RA business. They will work in conjunction with the RA business customers and across the Global IT organization to implement projects in support of RA. Short term areas of focus include deploying, managing and maintaining RA systems for: Worldwide product registrations submission Worldwide registration metrics system and Regulatory Reporting to the IT Director for Regulatory Affairs, this position will support regulatory initiatives by assisting in the planning and implementation of departmental information systems. Through others, this management role provides system analysis, business analysis, and technical support for the implementation, validation, and life cycle management of Regulatory systems/databases. The position also includes involvement in the full system development lifecycle and requires knowledge of the project implementation and management process. This will include chairing and participation in workshops, authoring and reviewing related requirement documents, and providing support in the selection, implementation, and validation of Regulatory systems/databases. Company Core Data Sheet Process Flow and Tracking Standard Operating Procedures and Compliance Database Regulatory Agency Submission Tracking and Archiving Global Regulatory Submissions and Archiving Global Regulatory Submission Schedule Tracking Overall, the role will develop requirements for, and manage and deploy systems in support of the Regulatory Affairs function. The incumbent will develop long range business strategies and requirements, formulate a technology vision and translate this vision, together with all stakeholders, into sustainable technology solutions for Baxter Regulatory Affairs worldwide. Key responsibilities of the position are: Manages a team of up to 15 employees and contractors supporting RA IT. Tracks status of all assigned Regulatory system projects. Recommends system improvements and has ownership for implementations. Defines and authors user requirement specifications Acts as liaison between Regulatory and IT by: Ensuring departmental strategy integrates with enterprise-wide IT technology strategy Representing to the IT department all Regulatory's IT needs in assigned areas Partners with IT and business partners to oversee implementation of application solutions. Evaluates and defines software solutions for complex global RA business problems. Ensures validation requirements are in compliance with FDA 21CFR Part 11 and related regulations. Assists in the design, build, testing, validation, and documentation processes. Participates in the selection of Regulatory systems/databases. In partnership with IT stakeholders and business customers, defines and enables strategies for handling decision support, emerging and waning applications, and portal / content management requirements. Identifies and communicates future technology trends, which will create opportunities and/or influence the technology direction for the Business Solutions functions. Initiates new solutions to aid in the automation of Regulatory processes by being aware of advancements in scientific computing technologies and current Regulatory guidelines. QUALIFICATIONS: Technical Change management Translation of process design into realistic system requirements Communicate technical ideas, thoughts, and facts in a clear, convincing, and organized fashion Work with geographically distributed architectures Program and Relationship Management Manage multiple priorities and projects Systems requirements definition Ability to ensure project timeline and budget/forecast commitments Provides appropriate rationale and context to drive commitment Conveys relevant information in a candid and timely manner Manages the needs and expectations of a diverse set of stakeholders Interacts regularly with customers to understand their business and to anticipate the necessary IT resources Effective meeting facilitation Ability to work in a matrixed IT organization to leverage information and resources from multiple sources Leadership Drives results through delivery of timely, high quality work that adds business value Track record of delivering large-scale and multi-technology projects that meet quality, time and budget requirements. Proven abilities in managing simultaneous projects in a matrix organization across regions. Achieves high level of customer satisfaction Makes sound business decisions that balance competing priorities Examine issues from a broad perspective, considering impact beyond immediate scope Establishes collaborative working relationships with the businesses, functions and regions and necessary IT functions to align IT to the business strategy Works with business partners to understand and "blueprint" application architecture, providing standard tools to enable businesses to meet their tactical and strategic goals Translates strategy into specific priorities, objectives, and action plans Develops appropriate metrics to assess performance Analyzes problems effectively and takes action to resolve issues Inspires creativity and innovation through the generation of new ideas Defines and implements business processes to identify, evaluate, and pilot emerging IT technologies to enable IT partners and business customers to quantify business value, develop business cases Promotes and enables technology sharing and reuse. Defines processes and techniques to facilitate reuse of key technology services Ability to develop, articulate, and build support around a long term vision and the ability to deliver concepts with quantifiable business value in support of that vision Experience in establishing cross business processes and services across international boundaries Ability to connect functional teams with technical teams to achieve effective solutions Excellent communication skills across IT and with businesses, functions and regions; ability to formulate vision and translate vision into technology with concrete standards and solutions. Strong business knowledge, presentation skills, verbal and written communication skills and teamwork skills. Ability to accomplish results through others. Developed influencing skills. Ability to engage senior executives through proactive networking. Results and execution focused, high drive, self-starter, self-motivated BS/MS in a scientific discipline Bachelor's degree in Computer Science or a related field preferred or relevant work experience. A Master's degree in computer sciences, engineering, or business is highly desirable. Excellent oral and written skills 5 to 10 years experience in supporting Regulatory Affairs, Pharmacovigilance or related functions from an IT perspective 5+ years managing team and leading large software development and implementation initiatives. Budget management experience. Desirable: Knowledge of GMPs Knowledge with FDA guidelines and rules relating to drug regulatory matters Past experience in Healthcare sector. As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits. To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V.