Senior Medical Writer: Regulatory AI Clinical Docs (Remote)

Executive Staff Recruiters / ESR Healthcare; New York (NY); Remoto; USD 90.000 - 135.000; Tempo pieno

Descrizione del lavoro

ESR Healthcare in New York, NY invites a Medical Writer (Pharmaceutical) to join as a contractor, focused on regulatory writing for AI-assisted clinical documentation. Remote work with NYC placement is offered, aiming for expert judgment across efficacy and safety narratives.

The role requires leading authoring of full Clinical Study Reports, strong ICH E3 knowledge, and experience across multiple trials and phases, including oncology/haematology, with excellent written and verbal communication.

Competenze

• Minimum 5 years of regulatory medical writing experience for clinical documents.
• Direct authoring or leadership of full Clinical Study Reports is required.
• Fluency with ICH E3 and safety documentation conventions.
• Ability to read TFLs and protocol documents and reconcile with source data.
• Strong written and verbal communication for structured feedback.

Mansioni

• Author and review CSRs, DSURs, PSURs/PBRERs, and related documents.
• Assess AI-generated content for clinical template compliance and references.
• Verify narrative accuracy against source records and protocols.
• Provide clear rationales to guide AI model improvements.
• Collaborate to refine evaluation frameworks for regulatory writing in AI.

Conoscenze

Regulatory medical writing

Clinical Study Reports

ICH E3 familiarity

eCTD knowledge

Scientific writing

Feedback on clinical content

Formazione

Advanced life sciences degree

Descrizione del lavoro

ESR Healthcare in New York, NY invites a Medical Writer (Pharmaceutical) to join as a contractor, focused on regulatory writing for AI-assisted clinical documentation. Remote work with NYC placement is offered, aiming for expert judgment across efficacy and safety narratives.

The role requires leading authoring of full Clinical Study Reports, strong ICH E3 knowledge, and experience across multiple trials and phases, including oncology/haematology, with excellent written and verbal communication.