Vacancy expired!
Job Description
The Principal Application Specialist will be a member of the R&D IT team reporting to the Sr. IT Partner in Regulatory IT. This position will provide oversight and support for all of the Regulatory and Preclinical platforms within the global Biogen community.
The Principal Application Specialist will play a critical role towards ensuring the availability, reliability, and usability of Biogen’s suite of applications for Regulatory and Preclinical in R&D.Key responsibilities:- Collaborate and lead a team in conjunction with Managed Service Provider (MSP) partners responsible for IT core support services and operations as required.
- Develop and maintain Support and Service models for production applications.
- Manage support team for day-to-day operational activities, e.g. ticket resolution, problem troubleshooting, coordinating activities with business, IT groups and vendors
- Create and maintain an informational IT knowledge base containing documentation of applications, policies, procedures, infrastructure, and other critical technology assets.
- Establish application SOP, Runbook, and Work Instruction documents and ensure support team follows change management processes Provide technical assistance to support analysts for managed applications
- Ensure routine maintenance tasks and system administrative activities are running smoothly to maintain reliable and effective operation of all applications.
- Drive the implementation of the IT vision and strategy for R&D(Regulatory)
- Coordinate incident management and drive resolution
- Demonstrate excellence in customer care, assurance and service quality; ensure all appropriate Service Level Agreements (SLAs) in core service metrics are met or exceeded.
- As a member of a global IT team, participate in problem resolution related to application issues across business units and regions; this includes working with business colleagues, business-facing IT colleagues, infrastructure teams, external partners, and/or vendors.
- Drive the implementation of the IT vision and strategy for R&D(Regulatory)
- Work with BA and IT System Owner on Regulatory and Preclinical projects e.g. application upgrade, patching and enhancements
- Manage production deployment of application patches and upgrades, including communications to users.
- Ensure change management processes are continuously followed to maintain a stable production environment.
- Sustain Software Development Life Cycle (SDLC) management through routine systems health assessment, maintenance of high-quality documentation, and real time license management.
- Understanding of GxP requirements including CFR 21 Part 11 and systems validation.
- Lead/support small and large changes in the Regulatory and Preclinical spaces
The ideal candidate will possess an accomplished professional track record combined with exceptional technical acumen, excellent written and verbal communication skills, and a demonstrated potential to continually grow into new responsibilities. They must be a self-motivated team player who is coachable, flexible, resilient, and comfortable working under high pressure with multiple deadlines and minimal supervision in a dynamic application support environment.
Qualifications
- 10+ years R&D application/platform management experience
- 5+ years collaborating closely with and/or managing technical IT support teams
- Demonstrated experience developing application support models
- Direct experience working with offshore support personnel and outsourced service providers
- Direct experience supporting Regulatory personnel in the biotech, academic, and/or pharmaceutical industries.
- Working knowledge of Regulatory systems (eTMF, publishing tools, RIM applications), Master Data Management systems, and System validation
- Experience or knowledge with Documentum
- Experience with Liquent Insight (a plus)
- Experience Cara RIM products (a plus)
- Experience with Systems administration, monitoring, performance tuning, and scripting
- Experience with various Unix/Linux operating system and proficiency in some scripting languages.
- Understanding of cloud application, support and maintenance
- Knowledge of IIS, Apache, Web Services, Active Directory, Group Policies, File/Share Security, and Networks to effectively troubleshoot application operations and performance issues.
- Exceptional analytical, problem-solving, and troubleshooting abilities.
- Strong written and verbal communication skills.
Education
- BA/BS in computer science, engineering, project management or related technical disciplines
Additional Information
All your information will be kept confidential according to EEO guidelines.
Vacancy expired!