職位描述
職位職能:
??醫(yī)療器械注冊(cè)??
職位描述:
JOB TITLE: PLD Specialist (product labeling)
Location: Shanghai
1. PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
Process before SFDA registration submission, PLD is responsible to follow up with AS and Marketing on technical translation and validation to improve quality of labeling as well as to secure efficiency of registration key document preparation; Process after registration approval, PLD should upload approved labeling file to Live link to improve labeling updates; PLD takes a lead for labeling issue solution, and answer questions labeling related.
(1) Keep close eye to SFDA new regulation and notice for the change impact on labeling.
(2) Support RA registration for new, renew and modification on labeling
(3) Support PLD manager on labeling issue management.
(4) Maintain database to sure its accuracy and most updated.
(5) Internal Q&A for labeling concerns
(6) Participate in project planning activities, assessing necessary resources and estimating timelines for documentation development and production.
(7) Ensure consistency of processes and deliverables. To do so, write and format documentation according to established templates (provided by Corporate PLD) and departmental styles and standards. Proofread documentation for accuracy and adherence to departmental styles and standards.
(8) Compile reports, spreadsheets, and documentation as needed to support departmental workflow.
(9) Responsible for translation coordination and consolidating and reconciling all markups from internal reviewers during translation process. Schedule and facilitate technical review meetings. Regularly interface with cross-functional subject matter experts to ensure accuracy of deliverables.
(10) Track and implement change requests, errors, issues, and requirements logged against documentation.
(11) Define and manage final deliverables and surrounding processes, following appropriate change management processes.
2. KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB
Experience & Personality:
(1) 2 working experience in related field.
(2) Good communication
Education & Knowledge:
(1) Bachelor Degree or above in Biology, Microbiology, Medical related.
(2) Good writing
(3) Excellent in English
