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

PMS Writer
• Writing a summary of safety and performance (SSP) for Class C and D IVDs
• Writing 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 & 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.