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Job Opening details:-
Company Name :- Makrocare
Position Name :- PMS Writer
Company Location :- Hyderabad, Telangana
Job Category :- Jobs in Hyderabad
Full Job Description :-
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
Writing a summary of safety and performance (SSP) for Class C and D IVDsWriting comprehensive SSPs by organizing and evaluating scientific/clinical/medical data.Managing SSP writing by planning, identifying, appraising and analyzing clinical/safety data then writing the SSP including conclusions based on expert knowledge.Ensuring quality by following internal and external SOPs, Work Instructions and Forms/Templates for successful preparation of robust SSPs and other documents.Assisting with other clinical, regulatory, quality and engineering projects as assigned.Responsible to acquire, interpret, analyze and draw conclusions from technical documents, clinical data from clinical trials, literature and experiences for a wide variety of medical devices.Responsible to communicate scientific content in a clear, concise manner.Other duties as assigned.
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 & PharmaBest Pharmaceutical Strategic Development Specialist – UK EnterprisesThe Outstanding Consulting Firm – Insights SuccessAI Excellence in Regulatory & Automation Solutions – Acquisition InternationalAI Excellence in Best Bio Pharma Development Partner – Acquisition InternationalBest Practices Award – Clinical Informatics
NJ Excellence Award – US Institute for Excellence in CommerceBest Biotech Award – US Commerce AssociationClinical 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 & SCRIPMakroTech is Awarded 3-time FAST 500 (Deloitte), 3-time INC 5000 company & TOP 100 diversity business in NJMakroFoundation is a Suicide Prevention Helpdesk, part of Makro CSR Initiative, has counseled over 3000 people.
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