Medical Writer Hiring at Quantys Clinical

Opportunity for Medical Writers | Gandhidham, Gujarat

Are you a skilled Medical Writer looking for a rewarding career opportunity? A reputed organization is hiring for Medical Writers in Gandhidham, Gujarat. If you have 2-5 years of experience and hold a B. Pharm, M. Pharm, BDS, or MBBS degree, this could be your next big career move!

Job Details

• Position: Medical Writer
• Location: Gandhidham, Gujarat
• Experience: 2-5 years
• Qualifications: B. Pharm, M. Pharm, BDS, MBBS

Roles & Responsibilities

As a Medical Writer, you will play a crucial role in clinical trial documentation, safety reporting, and regulatory submissions. Your key responsibilities will include:

• Inception, Trial designing, review and finalization of Clinical trial documents (Synopsis, Protocol, ICF, CRF, IB, etc.), Annual Study status report, Periodic Safety update reports, Final Trial report, Clinical Technical Document, SAE narratives.
• Review and study of received Safety Literature, Product complaints and Callbacks.
• Writing of narrative for Individual Case report and SUSARs for US-FDA.
• Filling of MedWatch form along with MedDRA coding and submission to US-FDA in stipulated timeline.
• Management of Clinical Trials with co-ordination and timely documents retrieval from Clinical Trial Site, PI, CRO and SMO.
•  Medical Writing of Clinical trial documents and submission to EC and RA.
•  Communication and management of CRO, SMOs and vendors.
• Initiation and maintenance of TMF.
• Management and enhancement of Trial recruitment.
• Investigational Product management, including labeling, blinding, randomization, dispatch, callbacks, and final reconsolidation.
• Monitoring, Medical monitoring, Site Initiation, Site Audit, Site close-out visits.
• Communication with trial sites, Ethics committees, etc.
• CTRI registration of clinical trials.
• Inception and Implementation of Standard Operating Procedures (SOP) and Work Instructions (WI) for the process

How to Apply?

Interested candidates can send their updated CVs to hr@quantysclinical.com

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