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Senior Business Analyst

3 months ago

Cambridge, Massachusetts, United States Biogen Full time
Job Description

About The Role


The R&D IT Senior Business Analyst (BA) will actively support GXP applications in the Clinical Sciences business area, specifically the electronic Trial Master File (eTMF).

The BA is responsible for the health and success of eTMF and related projects within a matrixed organization with direct relationships with various groups in the business as well as IT.


Key Requirements for this Role:
- Monitor, manage, and ensure predictable delivery of eTMF projects in a deadline-driven, regulated environment. Act as Project Manager for small projects.
- Drive delivery and accountability of internal staff as well as vendors and third-party project managers. Own the quality of the project deliverables.
- Enable early identification and escalation of risks and issues that require assistance, attention, or executive resolution.
- Own the eTMF system lifecycle management process and compliance requirements.
- Effectively communicate system and project status to leadership verbally or in written form.

What You'll Do


The BA ensures that system compliance and project deliverables meet high quality and GxP compliance standards.

The BA collaborates with project teams to ensure high-quality and timely delivery. They will facilitate activities of Biogen-internal resources, external vendors, and other partners.

Main Responsibilities:
- Develop GxP-compliant SDLC deliverables.
- Document business processes and use cases.
- Translate business to technical requirements and drive understanding of deliverables.
- Provide appropriate technical/functional software support throughout product and project lifecycles.
- Assist testing staff in designing test plans and scripts to validate functional requirements.
- Co-author operational support documentation.
- Support deployment and hypercare activities.
- Complete other ad hoc tasks as requested.

Qualifications

Who You Are
- Ability to operate effectively in a GxP matrix environment. Team player, yet able to work independently with minimal direction.
- Strong interpersonal and teamwork skills with the ability to interact with various stakeholders.
- Excellent oral and written communication skills.

Required Skills

- 5+ years' experience as a Sr. Business Analyst with a working command of requirements engineering and analysis tools.
- Highly experienced in SDLC management and iterative systems development methodologies with emphasis on eTMF system management.
- BA or BS in Computer Sciences or Data Sciences required.
- IT System Owner (Product Manager) with knowledge in change and release management, validation planning and execution, and system lifecycle managementFamiliarity with GxP, CFR 21 Part 11, and systems validation.

Knowledge:
- Regulatory audit and inspection support.
- Tools and Technology awareness: IQVIA eTMF, Veeva eTMF, CAPA/Deviation management, system management reviews, ServiceNow, ALM VERA, Document Management system, MS Project, MS Visio, and standard MS Office products.

Preferred Skills

- Advanced degree.
- CBAP certification.

Additional Information

Why Biogen?


Biogen's mission to find therapies for neurological and rare diseases sets it apart in the industry. The shared purpose of the team at Biogen is to work together to overcome obstacles and follow the science.

The company is resilient in its efforts to make an impact on patients' lives and change the course of medicine.

Together, the team at Biogen pioneers and thrives.


At Biogen, there is a commitment to building a culture of inclusion and belonging that reflects the communities served and the patients cared for. The company recognizes that diversity in backgrounds, cultures, and perspectives leads to greater innovation and strength. The focus is on creating empowered and inspired teams.

Learn more about Biogen's DE&I efforts.


All qualified candidates will be considered for employment without regard to various factors, under the law. Biogen is an E-Verify Employer in the United States.