GSK Hiring MSc Biochemistry, Biotech, Biology & Life Science- Apply Online
Job Title: Specialist Clinical e-submission & Technical Compliance
Job ID: 375009
Job Type: Full Time
Job Location: Bengaluru, India
To accommodate increased scope of the team and role; and to focus and provide subject matter expertise to 2 activity verticals (Clinical Publishing and Submission Delivery AND Document Quality Review and Standards) by creating value through mass and transversal application of resources and knowledge.
- To contribute towards the technical & procedural aspects (like, electronic submission requirements, compliance check, publishing, redactions, archival in EDMS, linking documents for submission, development of BLA AR and SANF, PLS graphics) in generation of high quality clinical/regulatory documents by GCD (Scientific/Medical Writing, Study Delivery Management), BSP, Clinical R&D, GRA and Public disclosure. Ensure technical & procedural compliance with business and regulatory requirements on standards (stipulated by GCP, HRAs, Internal), formats, systems and timeliness to produce quality functional deliverables.
- Independently perform compliance check and content QC of clinical and preclinical submission documents, including, but not limited to overviews and summaries, CSRs, IBs etc.
- Support in establishing a high performing and collaborative service model with optimum utilization of available capabilities, continuous development of people, processes and systems for assigned document types.
- Independently perform the following:
- 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, and PLS graphics.
- 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.
People and operations (20%)
- 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.
Educational Qualification: Bachelor’s Degree, Science (Pharmacy, life science, biology, chemistry, biochemistry, biotechnology, pharmacology) OR master’s degree (Preferred)
Knowledge & Application:
- 4-7 years of experience with science background & regulatory understanding would help in performing the assigned jobs more effectively and consistently.
- Example: compiling documentation for publishing, publishing documents as per specific HRA requirements, gathering information from protocol/CSR for data disclosure.