Technical Writer AI Governance & Policy, pharmaceutical SOPs (Remote)

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.
Document content will focus on responsible use of Artificial intelligence (AI) and the lifecycle process for an AI Use Case.

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.

15. 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.

16. Required Degree or Certification BS degree required. Master's degree or other graduate education level preferred.