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Regulatory submission specialist

$15/hr Starting at $25

With over 6 years experience I am the perfect freelancer to complete your tasks. I am reliable, I take my work seriously and I deliver it on time in order to meet TAT and SLA. ?My key skills are in lead generation & global regulatory submission for Pharma client.? I am a pharmacy professional and works with MNC for USA based Pharma client. I am also a fluent English speaker. ??? Summary of skills & abilities ??? Medical records review & Medical records summarisation as per Module 5. Scientific research, Journals and published paper search, Medical reports, & Drug reports by using PubMed. Pharmaceutical research, Pharmacovigilance, Drug safety, & Drug advice - Pharma global regulatory affairs: To prepare a dossier as per regulatory requirements and submit it electronically to respective regulatory body. - Clinical trial: To provide adminstrative assistant to Clinical research team for Phase 3 trial. To prepare database of investigators, and communicate financial and study aspect with shortlisted investigators. - Clinical data management: having experience in start up phase to Closed out via Oracle Clinical for Phase 3 trial. - Software testing (Manual testing) for our in-house study. - I'm good at advance MS Excel (Pivot table,H-lookup, H-lookup), MS Word, PowerPoint - Typing speed: 40 WPM.

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$15/hr Ongoing

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With over 6 years experience I am the perfect freelancer to complete your tasks. I am reliable, I take my work seriously and I deliver it on time in order to meet TAT and SLA. ?My key skills are in lead generation & global regulatory submission for Pharma client.? I am a pharmacy professional and works with MNC for USA based Pharma client. I am also a fluent English speaker. ??? Summary of skills & abilities ??? Medical records review & Medical records summarisation as per Module 5. Scientific research, Journals and published paper search, Medical reports, & Drug reports by using PubMed. Pharmaceutical research, Pharmacovigilance, Drug safety, & Drug advice - Pharma global regulatory affairs: To prepare a dossier as per regulatory requirements and submit it electronically to respective regulatory body. - Clinical trial: To provide adminstrative assistant to Clinical research team for Phase 3 trial. To prepare database of investigators, and communicate financial and study aspect with shortlisted investigators. - Clinical data management: having experience in start up phase to Closed out via Oracle Clinical for Phase 3 trial. - Software testing (Manual testing) for our in-house study. - I'm good at advance MS Excel (Pivot table,H-lookup, H-lookup), MS Word, PowerPoint - Typing speed: 40 WPM.

Skills & Expertise

Administrative AssistantData ManagementDatabase DevelopmentEnglish LanguageFinancial AnalysisLead GenerationMedicalMicrosoftMicrosoft ExcelModule DesignOracle DevelopmentReportsRequirements AnalysisResearchReview WritingSkillSoftware DevelopmentSummarizingTeam ManagementTyping

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