Site Name: Bengaluru Luxor North Tower

　　Posted Date: Dec 1 2023

　　• Compliance check, publishing and finalizing a variety of clinical and regulatory documents, including complex ones (Eg: CSR, IB, clinical overviews and summaries) as per the checklist, SOP and TUG. Ensure finalized/published documents are submission-ready and comply with GCP, HRA, GSK and other applicable international standards. Prepare electronic compilations in accordance with the functional and regulatory requirements on submissions - hyperlinks, bookmarks, pagination, TOCs, validation, eCTD - using appropriate prequalified systems/applications.

　　• Plan and execute collection and compilation of appendices in collaboration with internal stakeholders' as per GCP and GSK standards.

　　• Initiate and develop SANFs for protocols and IBs. Identifying and marking CCI/PPD and redaction, development of BLA AR.

　　• Act as an SME (lead for specific documents) and SPOC for specific documents and activities (per the SME roles and responsibilities). Ensure publishability (per internal and external standards) of document specific templates through appropriate review and approval.

　　• Coordinate and communicate to ensure eTMF compliance and inspection readiness of clinical regulatory documents.

　　• Perform content QC of assigned clinical regulatory documents to Identify inaccuracies (including numeric and stylistic) and inconsistencies in data within the submission document vs respective sources

　　• Check numeric accuracy and consistency of data within the clinical and preclinical documents (internal accuracy; text vs intext tables vs /figures)

　　• Accuracy of empirical data interpretation in the submission documents.

　　• Ensure compliance to internal style guide and other stylistic requirements.

　　• Support the team towards overall implementation of functional trackers, KPIs, and management monitoring.

　　• Collaborate with other functions to gain knowledge on changed requirements and take initiatives in implementing those changes in impacted functions.

　　• Effectively collaborate with FSO/FSP/third party, internal sponsor signatories, investigators and LOCs for timely approval and archival of clinical regulatory documents.

　　Act as a buddy/trainer for the new joiners and junior colleagues. Support associate publishers to resolve QC findings or risks/deviations, as needed. Impart cross functional trainings and awareness programs to GCD (Scientific/Medical Writing, Study Delivery Management), BSP, Clinical R&D, GRA and CT Transparency on assigned topics.

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　　GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

　　Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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