Senior Technical Writer — Regulated Biotech Documentation

Thornton Tomasetti; Madison (WI); On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott in Madison, WI is seeking a Senior Technical Writer to create and update technical documents for instruments, automation, SOPs, study protocols, and training materials.

You will lead documentation projects, mentor other writers, collaborate with Regulatory, Quality, R&D, and cross-functional teams, and ensure compliance with ISO 13485 and 21 CFR 820. Travel up to 10% may be required.

Qualifications

• Bachelor’s Degree or GED with 4 years relevant experience.
• 7+ years of technical writing in engineering/biotech.
• 3+ years in regulated document control environment.
• 2+ years in equipment/hardware technical writing.
• Proficiency in Microsoft Office programs.
• Authorization to work in the United States without sponsorship.
• Ability to perform essential duties of the position.

Responsibilities

• Manage projects to create and evolve documentation with regulatory, quality, document users, and SMEs.
• Mentor and review documentation, providing editing suggestions.
• Create educational materials and host workshops for Abbott Cancer Diagnostics.
• Collaborate with internal departments to support document needs and gaps.
• Develop project schedules and deadlines and ensure timely delivery.
• Lead pre-review of drafts with SMEs and reconcile comments for accuracy.
• Work with cross-functional SMEs to understand product, audience, and documentation requirements.
• Present information clearly through text and graphics to aid reader understanding.

Skills

Technical writing

Regulated environment

Cross-functional collaboration

Documentation management

Microsoft Office

Education

Bachelor’s Degree in Biotechnology, Engineering, or Technical Communications

GED with 4 years of relevant experience

Tools

Oracle Cloud PLM

Job description

Abbott in Madison, WI is seeking a Senior Technical Writer to create and update technical documents for instruments, automation, SOPs, study protocols, and training materials.

You will lead documentation projects, mentor other writers, collaborate with Regulatory, Quality, R&D, and cross-functional teams, and ensure compliance with ISO 13485 and 21 CFR 820. Travel up to 10% may be required.