IT Technical Writer - GxP environment

The IT Technical Writer will work directly with IT System & Regulatory Compliance and IT professionals to assist in documenting deviations, corrective actions, system development lifecycle (SDLC) remediation, system assessments, and updating procedures.  In collaboration with IT professionals, this role will assist in articulating complex information for IT Quality, business process owners (BPO), system owners (SO), and subject matter experts (SME) review and approval.  A key component of this role is to guide SMEs in providing the necessary information to ensure the content is specific to its purpose and audience, and clearly articulated for future audit and compliance reviews.

What You'll Do

• Documenting Root Cause Analysis (investigation details) and corrective actions for Deviations
• Updating System Development Lifecycle documentation to their latest IT Quality approved templates
• Creating and updating System Assessments for IT Applications
• Writing Validation Plans and Reports to support project teams during new system implementations and upgrades
• Updating Administrative Procedures to their latest IT Quality approved templates

• 3+ years of relevant experience
• GxP environment is a must have
• Excellent written and verbal communication skills
• Knowledge of IT computer system concepts
• Ability to operate independently to deliver on assignments
• Ability to interact independently with employees at all levels of the organization
• Bachelor’s Degree
• Fluent English

“Diversity is key for the survival of our ecosystem. I believe it is the single most important factor for a balanced flourishing environment where everyone thrives.”

Guy Hadari – Chief Information Officer- Biogen

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.

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