Subhasis Banerjee Email and Phone Number

-Provide strategic direction and leadership for end to end process delivery and improvements in the area of regulated and policy driven clinical disclosures and data sharing.-Accountable for operational delivery of the therapy area data disclosure plans. Lead and manage the Data Disclosure team to ensure timely, consistent and accurate delivery of data disclosure artefacts (e.g. protocol and result summaries, full protocols, reporting and analysis plans and clinical study reports) to… Show more -Provide strategic direction and leadership for end to end process delivery and improvements in the area of regulated and policy driven clinical disclosures and data sharing.-Accountable for operational delivery of the therapy area data disclosure plans. Lead and manage the Data Disclosure team to ensure timely, consistent and accurate delivery of data disclosure artefacts (e.g. protocol and result summaries, full protocols, reporting and analysis plans and clinical study reports) to external registers e.g. ClinicalTrials.gov, EU Clinical Trials Register and GSK Study Register, and to other national registers, as required-Have accountability for line leadership of a team of recognized subject matter experts/leaders who are also effective in influencing and engaging across multiple lines and regions. Manage outsourced resources to ensure resources to address workload beyond FTE capabilities-Maintain awareness of changes in the disclosure, transparency and data sharing landscape, including new legal, regulatory requirements and industry trends and translates into GSK’s Clinical Trial Disclosure and Transparency strategy. Oversight for maintenance and improvement of processes for disclosure function according to evolving requirements-Maintain GSK initiatives of building trust at the highest standards by continuous adaptation of the internal process to be aligned with the external evolving requirements. Provide medical governance advice in the field of clinical trial disclosure to stakeholders in therapy area-Maintain and leverage effective relationships with GMLT, Therapy area heads and other key stakeholders regarding progress and performance, and to ensure oversight of activities related to trial disclosure-Provide leadership in external working groups to develop common principles and standards to support clinical data transparency and data sharing and be a leader for GSK with industry-leading strategies in data transparency Show less

•Initiate project start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission. Coordinate and communicate with all the members in the study team for the development of clinical documents•To write, review and edit clinical documents that are part of regulatory submissions including but not limited to Clinical study report, Clinical study protocol, Clinical trial registry summary, Protocol summary, FDAAA/EudraCT Results… Show more •Initiate project start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission. Coordinate and communicate with all the members in the study team for the development of clinical documents•To write, review and edit clinical documents that are part of regulatory submissions including but not limited to Clinical study report, Clinical study protocol, Clinical trial registry summary, Protocol summary, FDAAA/EudraCT Results Disclosure, Safety narratives, and Clinical module of Common technical document of various therapeutic areas•Ensure uniformity and consistency in the scientific content of the regulatory documents by peer-review•To prepare, review and submit manuscript of early and late phase of clinical studies as per author’s guidelines of Journal/ICMJE guidelines/CONSORT•Adept in identifying the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines•Facilitated consistency in regulatory documentation and strategies by critically reviewing documentation and integrating regulatory trends•To give training to less experienced medical writers/new medical writers•Expertise in writing, executing, interpreting, and evaluating documents in terms of acceptability to industry standards, procedures, and regulatory requirements•A keen communicator with honed problem solving and analytical abilities•To participate in departmental process improvement and to take up training initiatives for team Show less

•Working towards implementation of CTDs (Common Technical Document) as well as NeES (Non-eCTD electronic submission) specifications & ensuring successful registrations of numerous ANDA for the US, Europe, Canada, Brazil and ROW markets•Conducting preparation and technical review of CSRs, study protocols, CRFs, ICF and IRB documents for pilot and pivotal bio-studies conducted by the company as well as various CROs for submission to regulatory agencies•Involved in generating more than 300… Show more •Working towards implementation of CTDs (Common Technical Document) as well as NeES (Non-eCTD electronic submission) specifications & ensuring successful registrations of numerous ANDA for the US, Europe, Canada, Brazil and ROW markets•Conducting preparation and technical review of CSRs, study protocols, CRFs, ICF and IRB documents for pilot and pivotal bio-studies conducted by the company as well as various CROs for submission to regulatory agencies•Involved in generating more than 300 bio-study reports conducted by the company as well as various CROs for timely submission to regulatory agencies as per current regulatory requirements•Completing the required documentation for global submissions and negotiating for the delivery of approved technical source documents in accordance with project timelines•Ensuring 505b(2) dossier preparation and submitted it to USFDA for their successful approval•Giving scientifically rational responses to queries raised by the various regulatory agencies regarding the bioequivalence studies•Liaising with various cross functional teams for generation of BA/BE study reports conducted by the company as well as various CROs for timely submission to regulatory agencies (USFDA, WHO, Europe, Canada, ANVISA, Australia, Malaysia and DCGI)•Providing periodic safety update of adverse drug reaction during and after the studies conducted by the company•Generating method validation reports and its addendums•Involved in identifying content, quality and/or timeliness issues with source documents, as early as possible•Playing a major role in defining the global regulatory strategy, identifying the critical issues and sharing lessons learned; updating the team about any potential issues which may affect the quality of the documentation or submission timelines•Facilitating consistency in regulatory documentation and strategies by critically reviewing documentation and integrating regulatory trends Show less

•Generated study reports of bioequivalence studies conducted by Ranbaxy for submission to various Regulatory Agencies•Developed method validation reports and other related technical documents for regulatory submission