Medical Writer - BA/BE Studies

1 - 6 years

7 - 14 Lacs

Posted:2 months ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Role & responsibilities

*Feasibility assessment/ new product evaluation

*Literature review and BA/BE study designing

*BE Study Monitoring

*Preparation of documents for regulatory submission (i.e BENOC, Import license application etc.)

*Establishment and maintenance of study documents

*Document preparation for dossier submission (i.e clinical overview, non-clinical overview, summery tables etc.)

*Review of BE study documents i.e protocol, reports, ICF etc.

*Preparation/review of medical write up

* Coordination for serious adverse event reporting and safety update to Regulatory agency

Preferred candidate profile

M.Pharm (Pharmacology) with 1-5 Yrs with relevant experience

vilshashah@torrentpharma.com&meghamaheshwari@torrentpharma.com

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Torrent Pharmaceuticals logo
Torrent Pharmaceuticals

Pharmaceutical Manufacturing

Ahmedabad Gujarat

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