Lupin Ltd Released Job Openings On 24/11/2022.Lupin Limited is an Indian multinational pharmaceutical company based in Mumbai, Maharashtra, India. It is one of the largest generic pharmaceutical companies by revenue globally.
Lupin Ltd hiring B.Pharma,M.Sc,M.Tech Graduates with 02-06 years of relevant experience for Research Associate – Medical Writer Position.Complete Details for the Research Associate – Medical Writer as follows.
Important Details :
- No of Vacancies:01
- Details of Salary: NA
- Opening date for online Application: 24/11/2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
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Job Description/Skills Required
- Collate and compile the data from various departments, required for report preparation. Ensure to initiate the writing activity after Protocol Training and Duty Delegation.
- Prepare the draft clinical study report and get it reviewed from respective stake holders and sponsors.
- Evaluate the report with respect to narrative description of events (deviations, Adverse events) and Results & Discussion. Assess [ or completeness and appropriateness of references mentioned in CSR.
- Review of complete study report inclusive of clinic, pharmacokinetic and statistical phase in case of partial/ complete outsourced study.
- To take account of preparation and review of CSR for complex generics. Injectable, Transdermal and Biosimilar products.
- Prepare the bioequivalence summary tables (m2, 2.7.1 , BTIF etc.) as per regulatory agency norm.
- To prepare, compile and submit dossier in eCTD format for regulated market as per the requirements mentioned in cCTD Technical Conformance Guide.
- Keep update oneself on all regulations regarding DCGI , FDA, EU, and GCP/ICH etc.
- Provide technical inputs as per the requirement for different regions in case of dossier review and co-ordinate with Regulatory Team.
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