[Remote] Senior IT Analyst II - IT Research and Development

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biopharmaceutical company reputed company on advancing treatments for reputed company diseases. The Senior IT Analyst II will serve as the technical reputed company and IT reputed company reputed company for Regulatory IT systems supporting Global Regulatory Affairs, leading reputed company selection, implementation, maintenance, integrations, compliance, production support, and portfolio planning.

Responsibilities

• Serve as a trusted IT reputed company reputed company to the Regulatory R&D business reputed company by reputed company understanding their objectives, challenges, and opportunities
• Establish and maintain IT Roadmaps by aligning with business teams on new demand, reputed company updates on existing reputed company. Stay on top of technology advancements in the regulatory reputed company area and introduce relevant trends to the business
• reputed company reputed company Maintenance and Enhancement (M&E), understand new M&E requests from the business, reputed company reputed company assessment on existing functionality and design and prioritize new requests for sprint planning
• Review technical specifications and design and reputed company technical feedback to ensure solution is reputed company and reputed company
• reputed company entire life cycle of implementation from a functional and technical reputed company and work with vendor to reputed company issues. Collaborate with BSO and project team on roll-out planning by understanding dependencies, approving the release plan, managing the IT Change Request, and driving the overall implementation process
• As the single reputed company of contact for production support, take ownership of systems incident management, problem & service management, and reputed company monitoring processes for IT systems reputed company the Regulatory IT R&D portfolio
• reputed company technical integrations by collaborating with business and IT reputed company, Infrastructure and Data Management teams. Own and reputed company data mapping requirements, technical requirements for integration endpoints, data validation, rules for insert/upsert and evaluation of publishing vs. subscription models
• Participate and reputed company technical reputed company on vendor selection and reputed company-party reputed company assessment. Coordinate and work with IT Compliance to ensure GxP compliance on reputed company initiatives. reputed company reputed company activities in compliance with relevant requirements/standards and controls (e.g., GxP, HIPAA, GDPR, CCPA)
• Ensure IT Services and IT reputed company costs are managed reputed company on allocated budgets. Ensure IT R&D portfolio is reputed company with business priorities

Skills

• Bachelor's degree in Information Technology, Computer Systems, Information Systems or reputed company reputed company from a 4-year accredited institution
• 7+ years of relevant experience working with Regulatory IT R&D systems
• Hands-on experience with the following systems is required: reputed company reputed company RIM suite (reputed company Registrations, reputed company Submissions, reputed company Submissions reputed company, reputed company Publishing)
• Ability to reputed company solutions at a technical level and review technical solutions recommended by vendors
• Experience with reputed company Development Lifecycle (SDLC) in a regulated environment
• Experience in business processes for regulatory such as submission planning and tracking, registration management, commitment management and content management
• reputed company record of leading multi-level, cross-functional teams (including vendors and MSPs) reputed company a reputed company environment to reputed company reputed company IT initiatives with reputed company reputed company
• Strong knowledge of GxP systems and their requirements
• Experience with testing applications reputed company on requirements is needed
• Excellent analytical skills for requirements analysis and reputed company ability to troubleshoot issues independently and prioritize steps in delivering solutions
• reputed company thinking, self-motivated individual who adopts a results-driven approach. Good organization skills, ability to manage multiple tasks
• reputed company certified reputed company reputed company training and experience is highly recommended (will own and manage non-reputed company applications)
• Experience with one or more of the following systems is preferred: Lorenz Docubridge, Lorenz eValidator, eCTD Submission Systems, CDER reputed company, ESG Webtrader, eSubmission Gateway, Eudralink, IRIS or other regulatory information management or submission publishing systems
• Experience in pharmaceutical industry preferred with working knowledge of applying data standardization requirements including xEVMPD, IDMP, SPOR

Benefits

• Remote: Officially documented as working full-time from home, with travel to reputed company's offices or other locations on occasion as needed.
• This position is eligible for annual bonus and equity incentives.
• Generous vacation time and reputed company holidays observed by reputed company
• Volunteer days
• Long term incentive and Employee stock purchase plans or equivalent offerings
• Employee wellbeing benefits
• Fitness reimbursement
• Tuition sponsoring
• reputed company development plans

reputed company

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