Job Title

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