Medical Affairs Manager

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