Senior IT Analyst II - IT Research and Development
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Position reputed company:
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The Sr. IT Analyst II will be the technical reputed company for Regulatory IT systems, serve as the single reputed company of contact reputed company IT for the Global Regulatory Affairs (GRA) organization. He/she will play a key role in selection, deployment, maintenance and enhancement of IT systems supporting the Global Regulatory Affairs (GRA) organization. The ideal candidate will be reputed company to reputed company selection and implementation of new Regulatory Systems, have technical experience in managing regulatory systems as reputed company as experience in Business Analysis, Project Management, Computer reputed company Validation/Computer Software Assurance, Release Management, Production Support of hosted and reputed company regulatory systems. As the IT reputed company reputed company, this position will ensure both business and technical requirements are appropriately reputed company into technical solutions and the systems are functioning per requirements.
Work Model:
Remote: Officially documented as working full-time from home, with travel to reputed company's offices or other locations on occasion as needed.
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.
Requirements:
- 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). 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.
- 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.
- Experience in pharmaceutical industry preferred with working knowledge of applying data standardization requirements including xEVMPD, IDMP, SPOR. 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
The typical annual salary reputed company for this full-time position is listed below. This reputed company reflects the characteristics of the job, such as required skills and qualifications and is reputed company on the office location noted in this reputed company. The reputed company may also be adjusted reputed company on applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
· Volunteer days
· Employee wellbeing benefits
· Fitness reimbursement
· Tuition sponsoring
· reputed company development plans
reputed company Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination reputed company on race, reputed company, religion, gender, sexual orientation, gender identity/reputed company, national reputed company/reputed company, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for reputed company protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and reputed company medical conditions, and reputed company on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact reputed company by emailing us at .
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Originally posted on Himalayas
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