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IT Technical Writer - GxP environment

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About the role

Job Description

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 # Qualifications
  • 3+ years of relevant experience
  • GxP environment is a must have
  • Excellent written and verbal communication skills
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Biogen is open for

  • People for
    Marketing & PR & Media
  • Interested to work in
    Warsaw
  • And have following skills
    Technical Writing
  • We are looking to fill a
    Full-time position
  • For talents with seniority
    Mid-level
  • With a capacity of
    40 hours per week
  • And we are happy to pay
    Get the app to see

The story

At Biogen, our mission is clear: we are pioneers in neuroscience. Since our founding in 1978 as one of the world’s first global biotechnology companies, Biogen has led innovative scientific research with the goal over the last decade to defeat devastating neurological diseases.
There are

1001+

employees in the company

500M+

Company annual revenue

Offices

With approximately 7000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark.
  • Canada flagCambridge
    Flexible hours
    Remote work
Office imageOffice imageOffice image

Markets

We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

Biogen is open for

  • People for
    Marketing & PR & Media
  • Interested to work in
    Warsaw
  • And have following skills
    Technical Writing
  • We are looking to fill a
    Full-time position
  • For talents with seniority
    Mid-level
  • With a capacity of
    40 hours per week
  • And we are happy to pay
    Get the app to see

This job opening is already off the market.
Get the app or see similar offers.