Excellent written and verbal communication skills and interpersonal relationship skills
Good ability to read, write and speak English
Solid knowledge and understanding of Edwards policies, procedures, and regulatory (e.g., medical, pharmaceutical) guidelines relevant to documentation
Solid understanding of medical device documentation development activities
Ability to manage confidential information with discretion and attention to detail
Contributes to the completion of more complex organizational projects and goals
Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Tanggungjawab
Manage DCC (document control center) operation by processing and retrieving documents and sending to internal or archiving
Lead special projects (e.g., documentation remediation) in collaboration with team members; identify opportunities for process improvement including developing and proposing solutions, and proposing new processes and system enhancement
Ensure compliance with internal procedures, coordinate and perform incorporation of approved changes to documentation (e.g. verify track changes to update drawing documents) and verify correct implementation to comply with EW and Local Regulatory Requirements
Responsible for final documentation review by processing, reviewing, and releasing product at distribution center and RLRP (right label right product)
Create labeling contents including add-on label, IFU and preprinted artwork with collaborating with vendors and internal stakeholders
Evaluate changes proposed by initiators and provide feedback
Manfaat
Medical Leave
Insurance Benefits
Soal Jawab Jawatan
Tanya soalan dan majikan akan menjawab tentang jawatan ini
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