MakroCare is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, 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 of pertinent developments through review of the biomedical and scientific literature 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 for development of new tissue-based IVD assays.
•Stay informed of regulatory health authorities’ performance evaluation requirements for IVD devices.
?Contribute to multi-functional project teams to support regulatory& NB clearance/approval worldwide as well as IVDR projects:
•Apply scientific expertise in the design of analytical and clinical studies 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 of clinical validation plans that document agreed-upon clinical development strategies.
•Support Scientific validity programs under IVDR regulation for several clients
•Critically evaluate clinical development activities as they occur to ensure quality.
•Review clinical diagnostic protocols, clinical study reports, and other documents that support clinical study planning and interpretation
MakroCare | A MakroGroup Company | www.MakroCare.com
MakroCare is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, 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:
• Best Biopharmaceutical Regulatory Consultancy Firm – Global Health & Pharma
• Best Pharmaceutical Strategic Development Specialist - UK Enterprises
• The Outstanding Consulting Firm - Insights Success
• AI Excellence in Regulatory & Automation Solutions - Acquisition International
• AI Excellence in Best Bio Pharma Development Partner - Acquisition International
• Best Practices Award - Clinical Informatics
• NJ Excellence Award - US Institute for Excellence in Commerce
• Best Biotech Award - US Commerce Association
• Clinical Research Team and Best Technological Development in Clinical Trials Finalists - Scrip Awards
• Circle Of Excellence – MerchantCircle
About MakroGroup | www.MakroGrp.com
Makro Group of Organizations established in 1996, Makro provides a complete range of solutions for every stage of business and information lifecycle.
• MakroCare, DDi, MakroTech and MakroScientific are MakroGroup Companies
• DDi Awarded 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 Prevention Helpdesk, part of Makro CSR Initiative, has counseled over 3000 people.