Medical Writer (Pharmaceutical) remote

Executive Staff Recruiters / ESR Healthcare; New York (NY); Remote; USD 90,000 - 135,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory medical writing

Clinical Study Reports

ICH E3 familiarity

eCTD knowledge

Scientific writing

Feedback on clinical content

Education

Advanced life sciences degree

Job description

Job Description

Medical Writer (Pharmaceutical)

https://jobs.micro1.ai/post/6da7a95c-8ab7-4b76-a835-b1a6554da382?referralCode=10002f4f-2f65-476f-b8d5-434a25460930&utm_source=referral&utm_medium=share&utm_campaign=job_referral

Role Type: Contractor

Location: Remote

Scope of Work

1. Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents to inform AI tool development.
2. Apply expert judgment to assess whether AI-generated content fulfills clinical template and structural requirements, including ICH E3 organization, section sequencing, cross-referencing, and appendix management.
3. Evaluate scientific accuracy in narrative sections such as efficacy, safety summaries, discussion, and conclusions, distinguishing true scientific or interpretive errors from stylistic differences.
4. Trace narrative claims to source records-tables, figures, listings, and protocols-to verify that all assertions are appropriately supported.
5. Provide clear and structured written rationales for each assessment, enabling precise diagnosis and improvement of AI model behavior.
6. Collaborate with project leads to refine evaluation frameworks and document best practices for clinical regulatory writing in the context of AI.

Preferred Qualifications

1. Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
2. Direct experience independently authoring or leading the authoring of full Clinical Study Reports, beyond summaries or partial contributions.
3. Fluency with ICH E3 and conventions for periodic safety documentation (ICH E2F, ICH E2C) and eCTD placement.
4. Demonstrated ability to read and interpret TFLs and protocol documents, identifying where narrative diverges from source data.
5. Exceptional written and verbal communication skills, especially in providing structured, actionable feedback on clinical content.
6. Advanced degree in life sciences, pharmacy, or medicine (PhD, PharmD, MD, MSc), or equivalent depth of authoring experience.
7. Experience across multiple clinical phases and therapeutic areas; oncology and haematology expertise is especially valued.

Join our customer's team and leverage your authoring expertise to help design the next generation of AI-assisted clinical documentation solutions. This high-bar role offers you the chance to shape how tomorrow's writing teams draft and review regulatory documents - through your expert input, judgment, and real-world experience.

Working Place

NYC, New York, United States

Company

ESR Healthcare