Senior Technical Writer (Imaging Services)

TL;DR

Senior Technical Writer (Imaging Services): Driving technical documentation and imaging system configurations for clinical research projects with an accent on Trial Configuration Specifications (TCS) and complex image review workflows. Focus on ensuring regulatory compliance, managing cross-functional stakeholder relationships, and optimizing data movement processes within a life sciences environment.

Location: Remote (US). Candidates must be based in the United States, with a preference for residents of AZ, CT, DE, FL, GA, IL, MA, MO, NH, NJ, NC, PA, UT, or VA.

Salary: $84,368–$120,000 per year.

Company

A global leader in clinical research technology, dedicated to accelerating the delivery of advanced medical treatments to market.

What you will do

• Develop and review critical technical documentation including Image Review Charters, study reports, and configuration specifications.
• Lead initiatives for imaging read and analysis system configurations at the project level.
• Serve as the primary technical contact for sponsors, facilitating meetings and resolving project-related issues.
• Support the Image Management group in QC efforts and data movement using programmatic tools.
• Drive process improvements and develop departmental SOPs for clinical documentation.
• Coordinate UAT for imaging system configurations and support site qualification training.

Requirements

• Fluent English required.
• Must be based in the United States.
• Proven experience in medical imaging or clinical development within the life sciences industry.
• Demonstrable knowledge of industry guidelines and regulations, specifically ICH-GCP.
• Experience troubleshooting medical image-related issues, particularly DICOM.
• Familiarity with Imaging Read Criteria such as RECIST 1.1, PCWG3, or Lugano.
• Bachelor’s degree in a technical or medical discipline.

Nice to have

• Medical Writing experience.
• Experience with MINT and MIM applications.
• Certifications such as CNMT, RT(N), RT(CT), or RT(MR).
• Master’s degree.

Culture & Benefits

• Comprehensive medical, dental, and vision benefits including FSA and HSA.
• 401(k) program with life, accident, and disability insurance.
• Paid time off including holidays and sick leave.
• Internal growth, development programs, and training opportunities.
• Equal Employment Opportunity employer committed to a diverse and inclusive workplace.