Title : Technical Writer / Co-Ordinator
Exp : 3 to 6 Years
Location : Hyderabad
Education : MS- Preferred / B.Sc or B.E – Scientific or Technical discipline required.
Mandatory : Fluent in both English and Chinese. Read / write / speak
- Minimum of 3 years relevant experience; Medical device experience strongly preferred.
- Education Required: MS- Preferred / B.Sc or B.E – Scientific or Technical discipline required.
- Good at using Office software and any Artworks software.
- Fluent in both English and Chinese, Good Writing skill in technical area in both English and Chinese.
- In order to reduce the lead time of Artworks process through reducing draft preparation lead time and review cycles, and to meet the needs of submitting docs for category application/type test of CFDA in early stage of PDP, a dedicated, experienced, knowledgeable role of technical writer & coordinator is highly needed.
- Keep work contact with contact points of Artworks teams in different GBU and get trained/knowledgeable quickly on the Artworks’ (including IFU, Manual, User Guide, and Label, etc) SOP, requirements to Job Requisition in different GBU.
- Generate templates/formats of Artworks of different product category, which is well aligned with the practice in different GBU.
- For each project, train different functions (PM, Marketing, RA, QA, Designing, Packaging, Clinic Affair, etc) with the information elements for Artworks corresponding to the functions and align with the functions on the common due date of providing the information elements to him/her.
- Draft the Artworks docs of both English and Chinese version, have proof reading by different functions, submit to Artworks teams of GBUs, update the draft when necessary, track and respond to the processing in GBU till end of the tasks.
- Provide timely Artworks docs with different version (draft/final, English/Chinese) for CE/510K/CFDA China Food and Drug Administration (CFDA) tests, Product Category application, Clinical Study, and Registration submission at different time according to project schedule.