Specialist Clinical eSubmission

1 month ago

Bengaluru, India GSK Full time
Nom du site: Bengaluru Luxor North Tower
Data de publication: Mar 4 2024

·       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.

Notre objectif est d'être l’une des entreprises les plus innovantes, les plus performantes et dignes de confiance de l'industrie pharmaceutique. Nous pensons que nous apportons quelque chose d'unique chez GSK et lorsque nous associons nos connaissances, nos expériences et nos styles, l'impact est incroyable. Venez rejoindre notre aventure chez GSK où vous trouverez l'inspiration pour faire au mieux votre travail pour nos patients et pour nos clients. Un endroit où vous pouvez vous recentrer, vous sentir bien et aller de l'avant.

  

Avis important à l'attention des sociétés de recrutement/agences pour l'emploi

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