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Medical Lead (15h Left)

Medical Lead (15h Left)

Biocon BiologicsIndia
11 hours ago
Job description

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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15H Left • India

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