Senior Medical Writer

About Us

Axtria is a global cloud software and data analytics company focused on life sciences. Within Clinical Solutions, we are scaling Axtria Rapid CSR, a GenAI‑powered capability that helps medical writers produce high‑quality, ICH‑aligned CSR sections 30–50% faster by orchestrating multi‑source clinical inputs (TLFs, protocols, SAPs) with human‑in‑the‑loop validation

Role Overview :

We are seeking an experienced Medical Writer to lead the LLM powered authoring of Clinical Study Reports (CSRs) and clinical trial documents. This is a client-facing role requiring strong scientific writing expertise, regulatory knowledge, and familiarity with emerging GenAI technologies for medical writing automation.

Key Responsibilities :

• Client discovery, scoping, and requirements (business‑side)
• Lead requirements elicitation with client Medical Writing / Regulatory teams for CSR authoring (template standards, TA nuances, target sections, review cadence, acceptance criteria, quality bars).
• Translate business goals (timelines, submission strategy, risk tolerance, review workflows) into clear deliverables and negotiate scope, timelines, and costs; manage change requests and approvals.
• Define 'done' for each CSR section (e.g., Safety Evaluation, Efficacy) including scientific tone, numerical consistency, and ICH E3 alignment; maintain a living Requirements & Assumptions log
• Translation to technical work (internal hand‑off)
• Convert business requirements into technical briefs for the GenAI Engineer (priority TLFs, required tables / figures, prompt constraints, style rules, traceability links to sources)
• Specify validation frameworks for GenAI outputs (accuracy, completeness, faithfulness, numerical parity with TLFs) and co own evaluation rubrics with engineering.
• Own the backlog for Rapid CSR features during engagements (as Business PO), prioritize bugs / iterations based on medical writing impact and regulatory readiness
• Run structured review cycles (internal QC à client SME review à stat review) and close comments to final

Location : Pune, Gurugram, Noida, Hyderabad, Bengaluru

Required Skills and Qualification :

Soft Skills :

Why Join Us

Skills Required

Ml, Sap, regulatory guidelines , Ai, Sdlc, Medical Writing