Medical Lead

3 weeks ago

Yelahanka, India Biocon Biologics Full time

JOB DESCRIPTION - Effectively support the Clinical strategy from TPP till submission of the dossier to regulatories like (FDA, EMEA, DCGI,…) in the - Prepares/Reviews CDP, IB, study protocols, ICF, briefing book for scientific advices, TLFs and CSRs - Actively work towards approaches for faster completion of trials and having a patient centric approach.. - Provides/Reviews medical inputs for study conduct as per applicable GCP, SOP and regulatory requirements. - Provides inputs on study level data including GCP-issues report. - Attends regular meetings with CRO and/or other vendors. - Supports and oversees activities of study conduct e.G. site selection, interaction with investigators and other service providers. - Accountable for accuracy of trial information in all trial Registries such as Clinical Trials Registry – India (CTRI), Clinicaltrials.Gov etc. - Contributes to medical aspects and take part in study initiation and investigator meetings. - Provides inputs in to protocol deviation decision. - Medical monitoring which includes data reviews, EDC reviews. - Oversees CRO and conducts study specific medical monitoring which includes review of daily lab alerts and SAEs to communicate with CRO regarding follow-up. - Supports audits and inspections. - Monitors safety of subjects participating in clinical trials. - Supports pharmacovigilance department in preparing safety documents. - Supports statistics team in the conduct of Data Safety Monitoring Board interim analysis meetings. - Prepares/Reviews IND / IMPD medical documents, annual updates, MAA/CTD and other regulatory - Supports in DBL (provide inputs on Tables, Listings and Figures, actively participate DBL meetings). - Prepares/Reviews Protocol Synopsis, Safety forms etc. - Prepare/ Reviews study documents e.G. SAP, DMP, SMP, DSMB charter, MMP, Imaging charter. - Provides inputs on final TLFs, works with medical writer to review & revise CSR document, draft discussion and conclusions, participate in comment resolution meetings. - Support Regulatory scientific meetings and MAA approvals (USFDA/EMA/PMDA/CDSCO and other regulatory authorities across different regions and countries) for clinical aspects. - Supports in Handling of Regulatory, Marketing or any other molecule-related queries - Supports department activities like SOP preparation and review / external potential partner scientific discussions / consultant interaction. - Supports in the dissemination of important scientific information through articles or presentations or training. - Performs other related duties as assigned. - Provide scientific /Medical rationale or justification on specific products or therapy area

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