Pharmaceutical Medical Writer

SaidGig; New York (NY); Remote; USD 41,000 - 83,000; Full time

Job summary

SaidGig is seeking a remote contract medical writer to author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents.

Ideal candidates will have 5+ years of regulatory medical writing experience, proficiency with ICH E3, E2F/E2C and eCTD, and a track record of leading CSR authoring. This remote engagement emphasizes rigorous QA and evidence-based feedback.

Qualifications

• 5+ years of regulatory medical writing with sponsor, CRO, or as independent consultant.
• Experience independently authoring or leading complete Clinical Study Reports.
• Fluency with ICH E3, periodic safety docs (ICH E2F/E2C), and eCTD placement.

Responsibilities

• Author and review evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs and related clinical documents.
• Assess AI-generated content for clinical template/structure, ICH alignment, and appendix management.
• Provide structured written rationales to guide AI model improvements.

Skills

Regulatory medical writing

Clinical study reports

ICH E3 familiarity

Quality feedback

Remote collaboration

Education

Advanced life sciences degree (PhD/PharmD/MD/MSc)

Job description

This remote contract role centers on authoring realistic evaluation tasks, reviewing AI-generated clinical content, and providing expert feedback grounded in source data and regulatory standards. No prior AI experience is required.

Key Responsibilities

• Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents.
• Assess whether AI-generated content meets clinical template and structural requirements, including ICH E3 organization, section sequencing, cross-referencing, and appendix management.
• Evaluate scientific accuracy in efficacy, safety, discussion, conclusion, and other narrative sections, separating scientific or interpretive errors from stylistic differences.
• Trace narrative claims to source records, including tables, figures, listings, and protocols, to confirm that assertions are supported.
• Provide clear, structured written rationales that help identify and improve AI model behavior.
• Collaborate with project leads to refine evaluation frameworks and document clinical regulatory writing best practices for AI-assisted documentation.

Qualifications

• At least 5 years of regulatory medical writing experience with a sponsor, CRO, or as an independent consultant.
• Experience independently authoring or leading the authoring of complete Clinical Study Reports, beyond summaries or partial contributions.
• Fluency with ICH E3, periodic safety documentation conventions including ICH E2F and ICH E2C, and eCTD placement.
• Ability to interpret TFLs, tables, figures, listings, and clinical protocols, including identifying where narrative content diverges from source data.
• Strong written and verbal communication skills, particularly for delivering structured, actionable feedback on clinical content.
• An advanced degree in life sciences, pharmacy, or medicine, such as a PhD, PharmD, MD, or MSc, or equivalent depth of authoring experience.
• Experience across multiple clinical phases and therapeutic areas. Oncology and haematology expertise is especially valued.

Work Terms

Remote contract engagement.

Compensation

$30 to $60 per hour.