Senior Nonclinical Writer - Remote, Regulatory Submissions
MMS Holdings
Boston, MA
- Remote job
MMS Holdings Inc. is seeking a skilled regulatory writer to join our team, focusing on nonclinical documents for regulatory submissions. You will develop, write, and manage Module 2.4/2.6 eCTD content, IBs, study reports, and briefing documents. This full-time, remote role requires strong knowledge of GLP/ICH guidelines, excellent writing and project management skills, and the ability to lead cross-functional teams to deliver compliant submissions for INDs, CTAs, NDAs, BLAs, and MAAs. #J-18808-Ljbffr MMS Holdings
Vacancy posted 6 hours ago
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