GSK BSc, MSc Life Sciences, Biotech, Biochem & Biology Job Opening, Apply Online

GSK Hiring MSc Biochemistry, Biotech, Biology & Life Science- Apply Online

GlaxoSmithKline (or GSK) is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together. GSK is currently seeking a qualified professional for the position of Specialist Clinical e-submission & Technical Compliance. GSK Hiring MSc Biochemistry, Biotech & Life Science- Eligible and interested candidates check out the details below and Apply Online

Job Title: Specialist Clinical e-submission & Technical Compliance

Job ID: 375009

Job Category: Regulatory

Job Type: Full Time

Job Location: Bengaluru, India

Job Description:

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.

Job Purpose:

• 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.

Key Responsibilities:

Technical (80%)

• 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.

APPLY ONLINE

Here are a few Possible interview questions and answers that you might encounter for the Specialist Clinical e-submission & Technical Compliance Role:

1. Can you provide an overview of your experience in clinical e-submission and technical compliance? Answer: In my previous role, I have been responsible for performing compliance checks, publishing, and finalizing a variety of clinical and regulatory documents, including complex ones like CSRs, IBs, and clinical overviews. I have extensive experience in ensuring submission readiness and compliance with GCP, HRA, and international standards. I am also proficient in preparing electronic compilations, establishing hyperlinks, bookmarks, pagination, TOCs, and validating documents according to eCTD requirements.

2. How do you ensure technical and procedural compliance with business and regulatory requirements? Answer: I ensure technical and procedural compliance by closely following standard operating procedures (SOPs) and checklists provided by the organization. I stay updated with the latest regulatory requirements, including those stipulated by GCP, HRAs, and internal guidelines. Additionally, I regularly collaborate with internal stakeholders and subject matter experts to align document standards and formats. Continuous professional development and training help me stay abreast of changes and implement best practices in my work.

3. How do you perform compliance checks and content quality control of clinical and preclinical submission documents? Answer: When performing compliance checks, I meticulously review documents against checklists, SOPs, and regulatory guidelines to ensure all requirements are met. I pay attention to details, such as accurate data interpretation, numeric accuracy, stylistic consistency, and adherence to internal style guides. For content quality control, I cross-reference data within the submission document with the respective sources to identify inaccuracies and inconsistencies. I also check for internal accuracy, coherence between text and intext tables/figures, and the overall quality of empirical data interpretation.

4. Can you describe your experience in establishing a collaborative service model and effectively utilizing available capabilities? Answer: In my previous role, I actively contributed to establishing a collaborative service model by fostering open communication and teamwork. I believe in optimizing available capabilities by understanding the strengths and expertise of team members. I encourage knowledge sharing, provide training, and act as a mentor for new joiners and junior colleagues. I also collaborate with other functions to gain insights into changed requirements and initiate necessary changes within the team.

5. How do you ensure eTMF compliance and inspection readiness of clinical regulatory documents? Answer: To ensure eTMF compliance and inspection readiness, I closely coordinate and communicate with internal stakeholders, including FSO/FSP/third-party personnel, sponsor signatories, investigators, and LOCs. I ensure timely approval and archival of clinical regulatory documents according to established procedures. I stay updated with the latest regulatory requirements regarding document management and ensure our processes align with industry best practices to maintain inspection readiness.

Editor’s Note: GSK Hiring MSc Biochemistry, Biotech, Biology & Life Science- Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook and Instagram.