BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a CMC Technical Writer to work for a leading San Diego biotechnology company.
CMC Technical Writer
LOCAL SAN DIEGO CANDIDATES ONLY, PLEASE
The Temporary CMC Technical Writer will create and/or revise CMC dossier content from source documentation for regulatory submissions and will provide writing support for technical reports. The incumbent will have essential duties and responsibilities such as writing and reviewing protocols and/or reports for process development and manufacturing studies; writing CMC sections of a dossier from source documentation and writing, reviewing and proof-reading CMC documents as needed. Other duties as assigned. This is intended to be a 8-month assignment at 40hr per week.
Experience and Education Qualifications:
BS in Chemistry or life sciences.
Demonstrated CMC submission technical writing skills required.
Experience with small molecule product filings with at least 5 years of pharmaceutical industry experience in pharmaceutical manufacturing or development is required.
Excellent knowledge of English language with strong proof-reading skills required.
Expertise with Chem Draw and MS Office (Word, Excel, VISIO) is essential. Experience with templates and a Documentum-based system is a plus.