MakroCare is an Expert Strategic Development andCommercialization Global Partner for Pharmaceutical, Biotechnology and MedicalDevice industries. Our Experience, Programs and Processes bring a New Dimensionto Development Strategy, Regulatory/Risk Planning & Management, ClinicalResearch, Medical/Scientific Support and Emerging Region Expansion
Sr. Analyst (Diagnostics)
The successful candidate will: •Assess the medical value of novel in vitro diagnostic (IVD) assays in the context of the proposed intended use: •Stay abreast ofpertinent developments through review of the biomedical and scientificliterature and conference attendance. •Maintain broad medical, clinical, and scientific knowledge of cancer diagnostics technologies and applications.•Analyze and document the clinical, biological, and scientific rationale fordevelopment of new tissue-based IVD assays. •Stay informed of regulatory healthauthorities’ performance evaluation requirements for IVD devices.?Contribute to multi-functional project teams to support regulatory& NB clearance/approval worldwide as well as IVDRprojects: •Apply scientific expertise in the design of analytical and clinicalstudies to the creation of development strategies for validating the clinical utility and performance of new IVD assays in the context of their intended uses. •Assume primary responsibility for preparation ofclinical validation plans that document agreed-upon clinical developmentstrategies. •Support Scientific validity programs under IVDR regulation forseveral clients •Critically evaluate clinical development activities as theyoccur to ensure quality. •Review clinical diagnostic protocols, clinical study reports, and other documents that support clinical study planningand interpretation
MakroCare | A MakroGroup Company | www.MakroCare.com
MakroCare is an Expert Strategic Development andCommercialization Global Partner for Pharmaceutical, Biotechnology and MedicalDevice industries. Our Experience, Programs and Processes bring a New Dimensionto Development Strategy, Regulatory/Risk Planning & Management, ClinicalResearch, Medical/Scientific Support and Emerging Region Expansion.
MakroCare is Certified ISO 9001 (QMS), ISO 27001 (ISMS),ISO 20000 (ITSM), ISO 14155 (Medical Device Clinical Investigations)
MakroCare Awarded as:
• BestBiopharmaceutical Regulatory Consultancy Firm – Global Health & Pharma
• BestPharmaceutical Strategic Development Specialist - UK Enterprises
• TheOutstanding Consulting Firm - Insights Success
• AIExcellence in Regulatory & Automation Solutions - Acquisition International
• AIExcellence in Best Bio Pharma Development Partner - Acquisition International
• BestPractices Award - Clinical Informatics
• NJExcellence Award - US Institute for Excellence in Commerce
• BestBiotech Award - US Commerce Association
• Clinical Research Team and Best Technological Development in ClinicalTrials Finalists - Scrip Awards
• Circle Of Excellence – MerchantCircle
About MakroGroup | www.MakroGrp.com
Makro Group of Organizations established in 1996, Makroprovides a complete range of solutions for every stage of business andinformation lifecycle.
• MakroCare, DDi, MakroTech and MakroScientific are MakroGroup Companies
• DDiAwarded by Insights Success, CIO, Corporate LiveWire, Pharma Tech Outlook,Clinical Informatics & SCRIP
• MakroTech is Awarded 3-time FAST 500 (Deloitte), 3-time INC 5000 company& TOP 100 diversity business in NJ
• MakroFoundation is a Suicide PreventionHelpdesk, part of Makro CSR Initiative, has counseled over 3000 people.