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This person will participate in the development, writing,
and management of highly technical nonclinical documents. This is a full-time, remote position.
Roles and Responsibilities:
Strong experience with development and writing of nonclinical documents (eg, Module 2.4 and 2.6 eCTD submission documents, 1st Edition Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs)
Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical submission documents for INDs/CTAs/NDAs/BLAs/MAAs, ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity
Ability to author based on highly technical sources such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data
Ability to develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documents
Interpre
📌 Senior Nonclinical Writer (Bogotá)
🏢 MMS
📍 Bogotá