Clinical Lead Job in Sun Pharmaceutical Industries Ltd
Clinical Lead
Sun Pharmaceutical Industries Ltd
4+ weeks ago
- Mumbai, Maharashtra
- Not Disclosed
- Full-time
Job Summary
Act as medical lead for assigned programs Develop study related medical/scientific documents (protocol, IB, CSR, medical monitoring plan etc.) Conduct/oversee medical monitoring activities for assigned clinical studies including protocol/therapeutic area training of study team, training of sites at IM/SIVs, addressing medical queries from sites, IRBs and regulatory agencies, ongoing review of data pertaining to efficacy/safety, subject eligibility, protocol deviation, and other medically relevant data. Review of Statistical Analysis Plan, Data Management Plan, Case report Form, CRF-Edit Check Documents and other relevant documents as applicable Review of clinical study results, TLF, CSR etc. Draft/review clinical sections of IND/NDA documents Developing Clinical Development Plan (CDP) and clinical strategy for company products in the assigned therapeutic area e.g. dermatology, rheumatology, GI etc. Includes developing Lifecycle management/extension plans for approved compounds. Engage with KOL/advisory board members in the relevant therapeutic area, leveraging the interactions for developing most efficient clinical study design Draft/review clinical sections of IND/NDA documents Determine and draft the questions pertaining to clinical plan for which regulatory agency (FDA/EMA) advice is needed and develop company position for regulatory briefing package Support in preparation of regulatory agency interactions by carefully analysing regulatory (FDA/EMEA) comments and drafting potential responses to support company position Prepare slide decks, spreadsheets and documents for presentation of study updates in cross functional and project review meetings Contribute to development of SOP, systems, processes Interact efficiently with cross functional teams for smooth management of assigned activates Fluency in use of tools like sharepoint, excel, power point & word Basic understanding of drug development process, biostatistics, GCP and other clinical research aspects. Familiarity with websites where trial results/protocols are posted and ability to do independent literature search. Ability to collate and analyse competitive intelligence in order to support CDP /clinical strategy and protocol writing
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