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
Labeling Analyst
• Scientific contribution to the Labeling group and work in concentration with Clinical, PV, DRA and Medical Affairs globally. Collaborate closely with cross functional teams on labeling projects to deliver per mutually understood timelines.
• Creating updating labels per regulations and company policies.
• Preparing responses for Health Authority queries.
• Achieve consistency in labeling and Regulatory labeling process through regulatory standards, cross functional collaboration and interactions with health authorities where appropriate. Maintaining Pharma/ Device updates related to labeling guidelines and regulations as they pertain to the development/maintenance of IFU, CCDS, US, EU and ROW labeling .
• Focus on details of the scientific/medical documentation required to ensure accurate and complete label development, evaluations, reviews, and approvals.
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.