| CMC-Regulatory WRITING 100%Remote at Remote, Remote, USA |
| Email: [email protected] |
| From: Gulshan, Stellent IT [email protected] Reply to: [email protected] CMC/Regulatory WRITING 100%Remote Phone+Skype 12+Month Job Dsecription This is a CMC regulatory writing role; it requires applicants hands-on authoring experience with CMC regulatory dossiers (not a medical writer, or R&D technical reports, SOPs, CAPAs/deviation reports, etc) and the ability to digest and extract technical content into eCTD content suitable for the respective regulatory goal. Key Responsibilities: Author the CMC sections of regulatory documents (e.g., IND/IMPD, BLA/MAA, health authority questions, briefing documents) to support the timely submissions of investigational and marketing applications of primarily biologics Contribute to global regulatory writing strategy for CMC content and drive CMC content requirements on assigned projects. Interpret and summarize complex data in close collaboration with technical line SMEs Develop timelines, prepare and manage the review and approval of submission ready documents. Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations Critical review of submission documents to ensure messaging is clear and consistent within and across documents Well versed in formatting using Microsoft Word and authoring tools, and perform final copyediting checks of CMC documents Desired Abilities: Experience in regulatory submissions, supporting the preparation of Module 3 components of a submission, related Quality/CMC documents and components, and regulatory briefing documents Critical evaluation of analytical data with knowledge of fundamental principles of biochemistry, bioprocess, and/or pharmaceutical development Good writing skills for technical content and scrupulous attention to detail Excellent verbal communication skills for leading meetings and constructive remote interactions Negotiate the delivery of approved technical documents in accordance with project timelines Work well in team setting on a fast-paced business critical project Able to work independently, strong ability to prioritize workload Knowledge and experience using regulatory information management systems Education and Experience: Scientific background (B.S or M.S.) to understand pharmaceutical drug development concepts, CMC regulatory concepts, and create documentation based on these concepts Comprehensive understanding of regulations and quality guidelines to enhance probability of regulatory success and compliance Demonstrated excellence in project management Keywords: rlang information technology |
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| Sat Sep 09 03:49:00 UTC 2023 |