Job Description

The ideal candidate is a technical writer and project manager for CMC Biologics. The primary responsibility is to ensure completeness of the Quality sections of dossiers for regulatory filings and to respond to and resolve questions/comments from regulatory agencies.Key Responsibilities Coordinate internal and external activities pertaining to the Quality section of dossiers, including outsourcing studies. Review technical documents prepared by technical teams and ensure accuracy, compliance, and completeness for regulatory submissions. Author and drive completion of the Quality section of dossiers for clinical trial and marketing authorization applications. Ensure that final versions align with requirements and fulfill regulatory agency expectations. Provide responses to regulatory agency and due diligence questions, resolve issues and update dossiers in a timely manner. Monitor CMO/CDMO activities and provide support as a CMC point of contact. Review or approve technical documents (e.g. Master Batch Records, CoA, tech transfer documents) and resolve or escalate CMC/Quality issues. Project management (PM) responsibilities for both early and late-stage projects e.g. monitor project timelines and resource allocation, cross-functional liaison, ensure proper documentation of project-related activities, and other PM-related tasks.The Ideal Candidate Will Have PhD with relevant experience in the biopharmaceutical / biotechnology industry. Hands on experience in functional assays or analytical characterization for biologics is a plus. Candidates who wish to make a transfer from lab work to technical writing / PM / CMC regulatory are welcomed. Knowledge of upstream and downstream bioprocessing is a plus. Experience in dossier or technical writing for biologics is a plus. Excellent command of English language (especially writing skill). Excellent interpersonal and communication skills. Project management experience with a track record in problem solving and liaison across functions. Proven ability to work on own initiative. Pro-active attitude with good judgement. Excellent organizational, planning, and time management skills. Detail oriented, but able to work efficiently with others to meet tight deadlines. Proven ability to work well under pressure.
Not Specified