Job title: Associate – Clinical eSubmission and Technical Compliance Delivery

Company: GlaxoSmithKline

Job description: Job Description : Site Name: Bengaluru Luxor North Tower Posted Date: May 6 2022 Proposed Job Title – Associate, Clinical Submission and Technical Compliance Delivery Ready to help shape the future of healthcare? At GSK, we have already delivered un

Job Description : Site Name: Bengaluru Luxor North Tower Posted Date: May 6 2022 Proposed Job Title – Associate, Clinical Submission and Technical Compliance Delivery Ready to help shape the future of healthcare At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact stronger and more sustainable shareholder returns and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster accountable for impact – with clear ownership of goals and support to succeed and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. Rationale for Review : To accommodate increased scope of the team and role and to focus on delivering timely and quality deliverable in 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 support 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. Key Responsibilities: Technical (90%): Independently or with supervision perform the following tasks: Perform compliance check, publish and finalize less complex (Eg: SAP, mICF, SPM, protocol) clinical and regulatory documents, initiate and develop SANFs, BLA ARs, PLS graphics as per the checklist, SOP and TUG. Ensure finalized/published documents are submission-ready and comply with GCP, HRA, GSK and or other applicable international standards. Prepare electronic compilations (specifically Module 2 and Module 5 of eCTD) in accordance with the functional and regulatory requirements on submissions – hyperlinks, bookmarks, pagination, TOCs, validation – using appropriate prequalified systems/applications. Activities may include document level publishing, archival of documents, general PDF navigation, supporting conversion of paper documents to electronic format, and paper submissions. Plan and execute collection and compilation of appendices in collaboration with internal stakeholders’ as per GCP and GSK standards. Compilation of documents for IND, CTA, NDA submission for FDA/EMA/and other HRAs and link the published/finalized documents to the dossier area for relevant regulatory submissions. Perform redaction as per POL 70 and internal SOPs. Contribute in preparation of high-quality registrations and postings to ensure timely disclosure of accurate, consistent, and complete information of clinical trials on public databases (e.g. clinicaltrial.gov, Eudra CT). Perform marking and redactions of CCI and PPD information within clinical regulatory documents (e.g., protocols, SAP, CSRs, IBs). Act as a backup SME for specific documents (per the defined SME roles and responsibilities). Support performing content QC of assigned clinical regulatory documents 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 Keep electronic document management system (EDMS) up to date and compliant with internal processes and archiving requirements. Coordinate and communicate to ensure eTMF compliance and inspection readiness of clinical regulatory documents. Operational and People (10%): Support internal stakeholders in appropriately using document templates. Liaise with the study teams to gather information on applicable study file documentation and delivery timelines. Conduct or participate in meetings with specialists/managers, stakeholders to resolve compliance check findings or risks/deviations, wherever required. Contribute to effectively implement management monitoring system by complying with the accurate and timely updating the departmental trackers. Knowledge/Education Required: Minimum Level of Education Required – Bachelor’s Degree Area of Specialization – Science (Pharmacy, life science, biology, chemistry, biochemistry, biotechnology, pharmacology) Why is it required – To perform the responsibilities with a scientific approach and understanding of the pharmaceutical regulatory environment Preferred Level of Education – Master’s Degree Area of Specialization – Science (Pharmacy, life science, biology, chemistry, biochemistry, biotechnology, pharmacology) Why is it required – To keep up with the highly dynamic and ever-changing landscape of the pharmaceutical regulatory environment Previous Experience Required – Minimum Level of Job-Related Experience Required- 0-5 years Why is this level of experience required- To support delivery of high-quality regulatory documents intended for global submissions with or without supervision Knowledge & Application – 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 Problem Solving & Innovation – Basic to mid-level of problem solving skills, because the associate works with some degree of supervision Example: managing delays, communicating processes and quality expectations to stakeholders Interaction – Ability to communicate effectively to the stakeholders locally & globally, with some degree of supervision. Example: seeking reviews and approvals, managing assigned work Multi-Cultural Requirements – Mid level of awareness on cultural sensitivity and be able to accept and work accordingly in a global set up. Example: working closely with stakeholders that may be either co-located or remote. Be socially responsible and demonstrate respect and condor. Impact- Mid-level of multiple-area personal impact is required to perform and deliver quality work and timeliness. Example: Trainings to stakeholders, cross functions, etc At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution. .LI-GSK Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. 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Expected salary:

Location: Bangalore, Karnataka

Job date: Mon, 09 May 2022 22:17:11 GMT

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