Medical Lead

3 days ago

bangalore, 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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