Job Description
**General Description** **:**
This position is responsible for providing expertise to support the development of high-quality, fit-for-purpose clinical and regulatory documents to facilitate speed of information during development, submission, approval, and life-cycle management of products in BeiGene pipeline. The clinical and regulatory documents include, but are not limited to, clinical study protocols, investigator brochures, clinical study reports, regulatory briefing documents, and clinical modules of INDs, NDAs, BLAs, MAAs and other regulatory submissions. This position is also responsible for mentoring junior MWs (full-time employees and/or contractors/vendors) as needed.
**Essential Functions of the** **J** **ob:**
**Document Writing** **:**
+ Managesthe assigned writing tasks and ensuresthatthe documents adhere torelevant regulatory guideline(s), as well as BeiGene SOP/WI(s), template(s), and style guide.
+ Be able tomanagemultipledocuments at the same tim...
This position is responsible for providing expertise to support the development of high-quality, fit-for-purpose clinical and regulatory documents to facilitate speed of information during development, submission, approval, and life-cycle management of products in BeiGene pipeline. The clinical and regulatory documents include, but are not limited to, clinical study protocols, investigator brochures, clinical study reports, regulatory briefing documents, and clinical modules of INDs, NDAs, BLAs, MAAs and other regulatory submissions. This position is also responsible for mentoring junior MWs (full-time employees and/or contractors/vendors) as needed.
**Essential Functions of the** **J** **ob:**
**Document Writing** **:**
+ Managesthe assigned writing tasks and ensuresthatthe documents adhere torelevant regulatory guideline(s), as well as BeiGene SOP/WI(s), template(s), and style guide.
+ Be able tomanagemultipledocuments at the same tim...