Principal Application Specialist

Job Description

• Collaborate and lead the technical architecture discussions for Research and development clinical applications i.e CTMS, eTMF, Clinical Trial Transparency and Reporting tools.
• Assess the technical dependency, resourcing, risks, integration, upgrade, data & data center migration for clinical applications.
• Requirement assessment, analysis, development, and resource planning for integration of new business requirements.
• Co-ordination between business teams, internal and external technology teams, facilitate troubleshooting for complex technical issues, conduct POC’s, and provide solutions.
• Provide inputs to project planning, timeline, and resourcing.
• Responsible to ensure all the applications are compliant as per industry and organizational needs and processes (GxP, SOPs, SDLC, etc.)
• Engage and support MSP staff as required in day-to-day operations.
• Drive clinical application migration, enhancement, development, retirement and ensure organization’s process followed.
• Participate in enterprise-wide IT initiatives (i.e., IT Security, Platform Upgrades, Infrastructure update and upgrades), evaluate and plan the impacts on clinical systems, aligned the support team, and contribute to its success.
• Work with SaaS vendors to identify issues, fix them timely and address any security related issues. Maintain a good relationship with the SaaS vendors.
• Create, review, approve 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.
• Participate in problem resolution related to clinical application issues across business units and regions, which 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.
• Work with BA and IT System Owner on projects such as application upgrade, patching and enhancements.

• Lead and prepare support go live for all project and ensure the project to support transition occurs smoothly.
• 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.

Position requires travel 5% (100% domestic travel and 0% international travel).

May telecommute up to 30%.

Qualifications

Minimum Requirements:

Employer will accept a Bachelor’s degree (or foreign equivalent) in Computer Science or related field and 10 years of experience in the job offered or in a Principal Application Specialist-related occupation.

• 7 years of experience in the field of Information Technology.
• 4 years of experience in R&D IT working in Biotech Company.
• 4 years of experience in working in onshore/offshore environment.
• 3 years of experience working with Pharmaceutical GxP environment.
• 3 years of experience in working and supporting on CTMS, eTMF and reporting tools R&D Clinical applications.

Salary: $172,744/year - $183,500/year      

Additional Information

All your information will be kept confidential according to EEO guidelines.

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.