Job Details
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Job Id 454445
Title Medical Writer (CER)
Job Type Permanent
City Hyderabad
State Telangana
Zip
Job Description

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

 

 

Medical Writer (CER)

1. A CER writer will have an in-depth knowledge ofmedical writing and will be responsible for developing Clinical EvaluationReports (CERs) and assessing the need for product change CERs.

2. This individual will have demonstrated expertise inpartnering with clinical research, regulatory affairs, quality/reliability,product development, and bio-statisticians to develop schedules and timelyexecute tasks.

3. The individual will have demonstrated the ability todevelop solutions to complex problems and ensures that solutions are consistentwith objectives.

4. The individual will have a broad expertise incollaborating on a number of clinical and regulatory documents.

5.The role includes management of the clinical evidencereport writing process to ensure compliance to regulations and expectations ofRegulatory Bodies.

 

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

•             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

•             Best Biotech Award - US CommerceAssociation

•            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.

 


Qualification
Experience 3-6 Years
Job Category Medical Writer
Posted On 10/8/2020
Expires On 12/8/2020
 
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