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Job Id 564437
Title Sr. Analyst (Diagnostics)
Job Type Permanent
City Hyderabad
State Telangana
Zip
Job Description

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.


Qualification
Experience 3-6 Years
Job Category Medical Writer
Posted On 10/8/2020
Expires On 12/8/2020
 
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