Certara

Create documents for all phases of drug development, including manuscripts, abstracts, posters, oral presentations and slide sets through their lifecycle Independently write first drafts with input from lead author from CSR and/or TFLs Coordinate or complete journal/abstract submi المزيد...

Process regulatory documents per client specifications and rules or according to Synchrogenix standard rulesets and guidances, under agreed timelines, and within agreed quality standards Anonymizing and/or redacting protocols, SAPs, CSRs and other applicable documents in support of المزيد...

Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents Lead a project team, actively participate in development and writing of high-quality documents (study-level and submission level المزيد...