CMC Regulatory Technical Writer - REMOTE
Proclinical is seeking a remote CMC Regulatory Technical Writer for a global biopharmaceutical company.
Must be eligible to work in the US.
- 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
Skills and Requirements:
- 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
- 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
If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at +(1) 267-846-2026 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.