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Senior Associate, Medical Writing, MD at ClinChoice in Pasig | Swiftcruit
Medical WritingSystematic Literature ReviewClinical Evaluation ReportsSummary of Safety and Clinical PerformancePost-Market SurveillancePeriodic Safety Update ReportsPremarket ApprovalHealth Economics and Market AccessMicrosoft WordMicrosoft ExcelMicrosoft PowerPointSharePoint
Company Location
Pasig, Philippines
Remote Work Policy
Onsite
DUTIES & RESPONSIBILITIES:
Performs tasks according to the assigned medical writing activities including systematic literature reviews primarily for the generation of Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), State of the Art (SOA), Post-Market Surveillance (PMS) including Periodic Safety Update Reports (PSUR), and Premarket Approval (PMA) Food and Drug Administration (FDA) Reports, including Humanitarian Device Exemption (HDE), Investigative Device Exemption (IDE) Reports, and Health Economics and Market Access (HEMA) research. The specific tasks are to be determined based on the assigned role in the project.
Supports review of work done by peer teammates, on need basis
Alerts and escalates to senior members as required, whenever project deliverable risks are visualized, OR issues are encountered impacting the delivery schedule
Ensures error-free and acceptable quality of assigned deliverables
Responsible for ensuring training compliance and timesheet compliance
Ensures that all assigned goals (e.g., utilization and efficiency) are met as per set standards for the performance year
Follows and complies with the Company’s Code of Conduct, Policies, and Procedures
Responsible for confidentiality, integrity, availability, and safeguarding of data
Responsible for reporting of security incidents and PIMS breaches as applicable
Complies with company QMS, ISMS, and PIMS requirements and applicable regulatory requirements
Demonstrates adherence and compliance to PIMS/GDPR requirements as follows: data processed fairly, transparently, and lawfully; collected for specified and legitimate purposes; adequate, relevant, and limited to the specified purposes; processed in a secure manner
ROLE REQUIREMENTS:
At least 1-3 years of experience in medical writing, or any related field as applicable
Can work in a diverse team environment
Good analytical and comprehension skills
Proficient in time management and can work with minimal supervision,
Proficiency in oral and written English language
Proficiency in Microsoft Office Suites (e.g. Word, Excel, PPT, SharePoint).
EDUCATIONAL QUALIFICATIONS:
Minimum bachelor’s degree in any life sciences field
