We are excited to present a job opening at GSK for the position of Specialist Clinical e-submission & Technical Compliance located in Bengaluru, India. As a global leader in the pharmaceutical industry, GSK is committed to improving the health and well-being of people around the world. In this role, you will play a crucial part in ensuring regulatory compliance and quality assurance in the realm of clinical submissions. Your expertise will be focused on two key activity verticals: Clinical Publishing and Submission Delivery, as well as Document Quality Review and Standards. Apply now for the job opening at GSK
Job role : Specialist Clinical e-submission & Technical Compliance
Location : Bengaluru, India
Categories : Regulatory
Req ID : 375009
Site Name : Bengaluru Luxor North Tower] Education : Bachelor’s Degree, Science (Pharmacy, life science, biology, chemistry, biochemistry, biotechnology, pharmacology) OR master’s degree (Preferred)
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.
o 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.
Knowledge & Application needed for the job opening at GSK:
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.
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About the company : GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so that the company can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and the company aims to positively impact the health of 2.5 billion people by the end of 2030.
Here are some interview questions and answers to excel the job opening at GSK for the role of Specialist Clinical e-submission & Technical Compliance:
1. Can you describe your experience with clinical publishing and submission delivery processes?
Answer: In my previous role, I have been responsible for handling the electronic submission of clinical documents. I have prepared and published various types of regulatory documents, including clinical trial applications, investigator brochures, and protocols. I am familiar with e-submission systems and processes and have a good understanding of the industry standards and regulatory requirements.
2. How do you ensure compliance with regulatory guidelines and standards when reviewing documents for quality and accuracy?
Answer: When reviewing documents, I pay close attention to regulatory guidelines and standards. I verify that the documents are complete, accurate, and adhere to the necessary guidelines. I have developed a strong understanding of regulatory requirements through my experience, and I consistently apply this knowledge to ensure compliance during the document review process.
3. Can you provide an example of a complex clinical document you have published and explain the steps you took to make it submission-ready?
Answer: In my previous role, I worked on a complex Clinical Study Report (CSR). To make it submission-ready, I followed a checklist and standard operating procedures (SOPs). I ensured that all the necessary sections and appendices were included, and I formatted the document according to the functional and regulatory requirements. I also added hyperlinks, bookmarks, pagination, and table of contents (TOCs) to enhance the document’s navigability and compliance with eCTD standards.
4. How do you handle discrepancies or inaccuracies in clinical and preclinical documents during content quality checks?
Answer: During content quality checks, I carefully review the documents for discrepancies or inaccuracies. I cross-reference the data within the submission document with the respective sources to identify any inconsistencies. I also check for numeric accuracy and consistency within the document, ensuring that the data is accurately represented. If I identify any inaccuracies, I follow the necessary procedures to address and rectify them, collaborating with the relevant stakeholders as needed.Can you describe your experience in coordinating and ensuring eTMF compliance and inspection readiness of clinical regulatory documents?
5. Can you describe your experience in coordinating and ensuring eTMF compliance and inspection readiness of clinical regulatory documents?
Answer: In my previous role, I have been actively involved in coordinating and ensuring eTMF compliance for clinical regulatory documents. I have worked closely with internal stakeholders to gather the necessary documents and ensure they are appropriately archived in the electronic trial master file (eTMF). I have also participated in inspection readiness activities, ensuring that the documents are organized, complete, and readily accessible for regulatory inspections.
6. How do you stay updated with changing regulatory requirements and implement those changes in your work?
Answer: Staying updated with changing regulatory requirements is crucial in this role. I actively engage in continuous learning by attending relevant training programs, workshops, and industry conferences. I also regularly review regulatory guidelines and follow reputable sources for industry updates. When there are changes in regulatory requirements, I proactively implement them in my work by updating processes, checklists, and templates to ensure compliance
ALL THE BEST !
