Technical Writer II (GXP) – Policy and Procedure for AI Governance

Description

Location: US remote 
Work Schedule - Estimate 5 days/ week 12-24 hours/week through September 2025.

• The Technical Writer II (contractor) in the CDS Bridge Process Development department will support the development of a policy and procedural document for the Enterprise Data Science Council (EDSC).
• The EDSC is a cross-functional body that is leading development of enterprise data and AI policies and processes at client.
• Document content will focus on responsible use of Artificial intelligence (AI) and the lifecycle process for an AI Use Case.
• Part-time schedule 5 hours/ day - Estimate 12-24 hours/week through September 2025.

Responsibilities:

• Once provided key messages in an outline and access to subject matter experts, significantly contributes toward efficient content authoring of draft procedural document text.
• Edits and incorporates reviewer comments in policy and procedural document.
• Triages reviewer comments and leads a comment reconciliation meeting to obtain alignment from the cross functional review team.
• Tracks feedback, review comments, and document updates. Communicates comment resolution to team.
• Ensures that policy and procedural document are clear, concise and technically accurate.
• Ensures consistency both within and between the policy and procedural document.
• Verifies accuracy of own work and ensures compliance to internal style guides and templates.
• Tracks and manages multiple concurrent document updates including statuses, timelines, and action items.
• Copy edits documents (including grammar, syntax, punctuation, style, clarity and formatting) to a high professional standard.

Knowledge and Skills:

• Ability to independently perform highly detail-oriented work in writing, reviewing and editing procedural documents with high degree of accuracy and efficiency.
• Strong proficiency with MS Word required, experience with document management systems and MS Office tools preferred.
• Demonstrates strong verbal, written, and interpersonal communication skills.
• Demonstrates ability to complete high quality work on multiple concurrent projects under tight deadlines.
• Knowledge of AI Regulation (e.g. European Union AI Act, Colorado AI Act) and AI Governance Frameworks (e.g National Institute of Standards and Technology AI Risk Management Framework) strongly preferred.
• Knowledge of data privacy regulation and frameworks strongly preferred.
• Knowledge of drug development processes or the GxP quality framework strongly preferred.

Education and Experience:

• 5 years of relevant medical writing or technical writing experience of policies, procedural documents, or other GxP documents required.
• BS degree required. Master’s degree or other graduate education level preferred.
• Experience within a pharmaceutical/biotechnology organization, law firm, technology organization, or data science organization preferred.
• Experience writing or experience operationalizing data privacy policy or procedural documents strongly preferred.
• Board of Editors in the Life Sciences certification, American Medical Writers Association certification, or a certification related to procedural document writing or data science preferred.

Required Years of Experience:

• 5 years of relevant medical writing or technical writing experience of policies, procedural documents, or other GxP documents required.

Top 3 Required Skill Sets:

• Ability to independently perform highly detail-oriented work in writing, reviewing and editing procedural documents with high degree of accuracy and efficiency.
• Strong proficiency with MS Word required, experience with document management systems and MS Office tools preferred.
• Demonstrates ability to complete high quality work on multiple concurrent projects under tight deadlines.

Top 3 Nice to Have Skill Sets:

• Knowledge of AI Regulation (e.g. European Union AI Act, Colorado AI Act) and AI Governance Frameworks (e.g National Institute of Standards and Technology AI Risk Management Framework) strongly preferred.
• Experience writing or experience operationalizing data privacy policy or procedural documents strongly preferred.
• Board of Editors in the Life Sciences certification, American Medical Writers Association certification, or a certification related to procedural document writing or data science preferred.

Unique Selling Point of this role:

• Writer will collaborate with senior leaders across enterprise to develop 1 policy and 1 procedure for AI Governance. Policy has been drafted. Process map and outline for SOP are drafted.
• Required Degree or Certification BS degree required. Master’s degree or other graduate education level preferred.