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

PMS Writer

• Writing coherent, convincing SSPs by organizingand evaluating scientific/clinical/medical data.

• Managing SSP writing by planning, identifying,appraising and analyzing clinical/safety data then writing the SSP including conclusionsbased on expert knowledge.

• Ensuring quality by following internal andexternal SOPs, Work Instructions and Forms/Templates for successful preparationof robust SSPs and other documents.

• Assisting with other clinical, regulatory,quality and engineering projects as assigned.

• Responsible to acquire, interpret, analyze anddraw conclusions from technical documents, clinical data from clinical trials,literature and experiences for a wide variety of medical devices.

• Responsible to communicate scientific content ina clear, concise manner.

• Other duties as assigned.

   

  MakroCare | AMakroGroup 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 Awardedas:

  •             Best Biopharmaceutical Regulatory ConsultancyFirm – 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 Prevention Helpdesk, part of Makro CSRInitiative, has counseled over 3000 people.