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Axtria - Ingenious Insights logo
Manager-Clinical Solutions CoE Axtria - Ingenious Insights

8.0 - 12.0 years

0 Lacs

pune, maharashtra, india

On-site

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) Soft Ski...

Posted 3 days ago

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