Position : Medical Writer
Location : 100% REMOTE
Duration : Long Term Contract
Roles & Responsibilities:
• Experience in authoring and reviewing of PMS plans, PMS reports, PMCF plans, PMCF Evaluation Reports is preferable
• Ensure that CEP, CER and SSCP files are linked to appropriate Quality Systems and Regulatory documents (e.g. Risk Management, PMS, etc.) to make certain information is consistent and accessible where needed.
• Efficiency in conducting literature searches for authoring various types of reports.
• Should have working knowledge and retrieving complaints data from publicly available adverse event databases like FDA 510(K) MAUDE, MHRA, TGA, etc.
• Ensure compliance of operations with governing regulatory requirements
• Responsible for ensuring compliant creation and reviewing of CEPs, CERs, SSCPs within the business in accordance to local procedures, client’s guidelines and regulatory requirements