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.
Vacancy Details:
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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