Lupin Ltd Pharma Medical Writer Vacancy – Apply Online
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Job Title: Medical Writer
Location: Lupin Pune, Maharashtra, India
Eligbility Criteria/Experience:
- M.Pharm/ Ph.D/ M.Tech in with minimum of 3 years of hands-on experience in Medical Writing.
- Relevant experience in narrative writing, protocol, clinical study reports.
- Demonstrated problem solving skills and strategic planning ability
- Demonstrated ability to effectively communicate to external and internal clients.
- Good communication and presentation skills.
- Ability to manage concurrent projects.
Skills: Medical Writing, Narrative Writing, Clinical Study Protocol.
About the team:
In this role, you will be a part of the Medical Writing team. Collectively, the team is responsible for developing various medical report activities for Lupin Bioresearch Centre. An experienced individual with relevant and extensive experience in Medical Writing.
Come join them and be a part of this exciting, fast-paced, and goal-oriented team
Your Role
You will be responsible for:
- 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 the 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.
Apply Online Via LinkedIn
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