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
- Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents to inform AI tool development.
- 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.
- Evaluate scientific accuracy in narrative sections such as efficacy, safety summaries, discussion, and conclusions, distinguishing true scientific or interpretive errors from stylistic differences.
- Trace narrative claims to source records—tables, figures, listings, and protocols—to verify that all assertions are appropriately supported.
- Provide clear and structured written rationales for each assessment, enabling precise diagnosis and improvement of AI model behavior.
- Collaborate with project leads to refine evaluation frameworks and document best practices for clinical regulatory writing in the context of AI.
Preferred Qualifications
- Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
- Direct experience independently authoring or leading the authoring of full Clinical Study Reports, beyond summaries or partial contributions.
- Fluency with ICH E3 and conventions for periodic safety documentation (ICH E2F, ICH E2C) and eCTD placement.
- Demonstrated ability to read and interpret TFLs and protocol documents, identifying where narrative diverges from source data.
- Exceptional written and verbal communication skills, especially in providing structured, actionable feedback on clinical content.
- Advanced degree in life sciences, pharmacy, or medicine (PhD, PharmD, MD, MSc), or equivalent depth of authoring experience.
- 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