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
Medical Writer• Writing and reviewing clinical/regulatory documents such as clinical trial protocols, clinical study reports, investigator brochures, informed consent forms, and according to ICH or other guidelines• Other writing jobs and responsibilities assigned time to time• Develop templates for reports and other regulatory documents.• Take initiatives in process improvement areas• Lead and mentor other writers• Ability to work across teams as well as independently• Good communication & coordination with various people involved in the process• Good time management, and meeting deadlines and commitments
COMPLETE REMOTE JOB
MUST HAVE VACCINES OR BIOLOGICS EXPERIENCE
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.