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
• Prepare and provide functional / Clinical area inputsin preparation of clinical documents (Protocols, Studies, Study reports),Labeling, and other clinical study reports for both Drugs and medical devices
• Aid in preparation of documents & responses tohealth authorities in addition to documents such as clinical overviews andsummaries, etc.
• Be accountable for quality and adherence to timelinesat different stages of all projects
• Perform detailed literature search utilizing bothpublic and private databases and show apt while synthesizing the results
• Coordinate with other cross-functional teams in thedata review, analysis and reporting of clinical studies.
• Be responsible as Author and sometimes in conjunction withanother medical writer, for overall content and accuracy of study report beforeforwarding for final sign-off.
Assist with internal and external dissemination ofresults to Development Team, Investigators etc.
• Provide mentoring, and training for other team members
• Work with multinational project teams and coordinateactivities on multiple projects • Function independently with initiative andminimal guidance
• Have attention to detail and focus on quality
• Work effectively in a team setting, take overadditional responsibilities
• Travel to client locations involved for some projectsas needed.
• Other responsibilities as assigned by company
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
• AI Excellencein 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.