RFP Proposal Writer
MillenniumSoft Inc
Job Title: CMC Writer / Project Manager Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities. Responsibilities Develop clinical & regulatory documents, including CSRs, CSPs, IBs, ICFs, CTD Modules, NDAs, BLAs, and MAAs. Ensure compliance with ICH, GCP, FDA & EMA guidelines. Collaborate with Clinical, Regulatory, Biostatistics, and other cross‑functional teams. Support the preparation and submission of regulatory dossiers. Maintain high standards of documentation quality and timeliness. #J-18808-Ljbffr MillenniumSoft Inc
Vacancy posted 2 days ago
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