Rusan is a research driven pharmaceutical company having its Manufacturing Units in India and Worldwide Marketing of Pharmaceutical Formulation, Active Pharmaceutical Ingredients and Intermediates. The company has its own Research & Development centre at Kandivli (west), Mumbai, state of the art, Bulk Manufacturing Plant at Ankleshwar and Formulation plant at Dehradun and SEZ, Kandla having approval of MHRA (UK), MCC (SA) and other International Health Authorities. March 2008 – 82 Crs., Expected by March 2009 €“ 150 Crs.
Rusan Pharma Recruiting For Following:
- Qualification:B. Pharm, M. Pharm, BDS, MBBS
- Experience :03-07+years
- Role: Medical Writer
- Job Location: Gandhidham,Gujarat
If you are passionate about medical writing and meet the above requirements, please submit your resume at rasika.mashalkar@rusanpharma.com and corporatehr@rusanpharma.com .
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Job Responsibilities:
RUSAN PHARMA IS HIRING FOR MEDICAL WRITER FOR ITS CRO QUANTYS CLINICAL PVT. LTD.
Organisation: QUANTYS CLINICAL PVT. LTD. (CRO services of Rusan Pharma Ltd)
Location : Gandhidham, Gujarat.
Qualifications : B. Pharm, M. Pharm, BDS and MBBS
Experience : 3-7 yrs. in Clinical research
Roles and Responsibilities:
1. 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.
2. Review and study of received Safety Literature, Product complaints and Callbacks.
3. Writing of narrative for Individual Case report and SUSARs for US-FDA.
4. Filling of MedWatch form along with MedDRA coding and submission to US-FDA in stipulated timeline.
5. Management of Clinical Trials with co-ordination and timely documents retrieval from Clinical Trial Site, PI, CRO and SMO.
6. Medical Writing of Clinical trial documents and submission to EC and RA.
7. Communication and management of CRO, SMOs and vendors.
8. Initiation and maintenance of TMF.
9. Management and enhancement of Trial recruitment.
10. Investigational Product management including labeling, blinding, randomization, dispatch, call backs, and final reconsolidation.
11. Monitoring, Medical monitoring, Site Initiation, Site Audit, Site close-out visits.
12. Communication with trial sites, Ethics committees, etc.
13. CTRI registration of clinical trials.
14. Inception and Implementation of Standard Operating Procedures (SOP) and Work Instructions (WI) for the process.
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