Specialist Clinical eSubmission

1 month ago

Bengaluru, India GSK Full time
Standort: Bengaluru Luxor North Tower
Datum: 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.

Unser Ziel ist es, eines der innovativsten, leistungsfähigsten und vertrauenswürdigsten Gesundheitsunternehmen der Welt zu werden. Wir sind davon überzeugt, dass jeder von uns einen einzigartigen Beitrag zu GSK leistet. Wenn wir unser Wissen, unsere Erfahrungen und besonderen Talente vereinen, werden wir ein unglaubliches Ergebnis erzielen. Kommen Sie zu GSK und finden Sie einen inspirierenden Arbeitsplatz, an dem Sie Ihr Bestes für unsere Patienten und Verbraucher geben. Ein Ort, an dem Sie ganz Sie selbst sein, sich wohlfühlen und weiterentwickeln können.

  

Wichtiger Hinweis für Arbeitsvermittlungsunternehmen/‑agenturen

GSK akzeptiert keine Empfehlungen von Arbeitsvermittlungsunternehmen und/oder Arbeitsvermittlungsagenturen für die auf dieser Website ausgeschriebenen freien Stellen. Alle Arbeitsvermittlungsunternehmen/‑agenturen müssen sich an die Abteilung für gewerbliche und allgemeine Beschaffung/Personalabteilung von GSK wenden, um die schriftliche Einwilligung einzuholen, bevor sie GSK Bewerber empfehlen. Der Erhalt einer schriftlichen Einwilligung  ist Voraussetzung für jegliche Vereinbarung (sowohl mündlich als auch schriftlich) zwischen dem Arbeitsvermittlungsunternehmen/der Arbeitsvermittlungsagentur und GSK. Falls diese Genehmigung nicht erteilt wurde, wird davon ausgegangen, dass sämtliche Handlungen des Arbeitsvermittlungsunternehmens/der Arbeitsvermittlungsagentur ohne die Zustimmung von GSK oder ohne eine vertragliche Vereinbarung mit GSK unternommen wurden. Aus diesem Grund haftet GSK nicht für irgendwelche Gebühren, die aus solchen Handlungen oder aus Empfehlungen von Arbeitsvermittlungsunternehmen/‑agenturen für die auf dieser Website ausgeschriebenen freien Stellen entstehen.

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