CMC Regulatory Technical Writer in US-Remote

DURATION: 1 year from the start date (potential for extension and/or conversion)

100% Remote

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

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