Durham,
NC
12460
US
Posted: 09/07/2023
2023-09-07
2023-10-31
Job Number: 24921129
Job Description
CMC REGULATORY TECHNICAL WRITER
DURHAM, NC
Remote.
The pay ranges between $98.00 to $100.59 per hour.
Project Description:
- 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 .
Required Skills:
- 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 .
- 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 .
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-01492
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
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