Job title: Regulatory Specialist I – RIM

Company: GlaxoSmithKline

Job description: Job Description : Site Name: Bengaluru Luxor North Tower Posted Date: May 11 2022 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 Cons

Job Description : Site Name: Bengaluru Luxor North Tower Posted Date: May 11 2022 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. Job Purpose: Ensures that GSK portfolio of product regulatory information is maintained to a standard appropriate to support critical regulated processes including Pharmacovigilance and GMP-compliant product supply. This data also supports the efficient operational management of the Regulatory function, worldwide. The role provides operational support to RIMS end-users. Key Responsibilities: The information (data and documents) managed by Regulatory Information Management is critical to patient safety, regulatory compliance and effective business operations. The post holder is accountable for the quality and accuracy of their own work and for the support of the large number of other users across GSK. The role provides operational support to Regulatory Information Management Systems (RIMS) end-users. Responsibilities of this role are: Supervise and support and monitor quality of the work of junior colleagues Advise, train and support users of the global Regulatory Information Management (RIM) systems and procedures Accurate completion of more complex or non-routine data maintenance tasks to agreed schedule Ensure own work and that of junior colleagues is compliant with data standards and defined procedures Ensure defined quality control procedures are followed and appropriate actions taken following any issues identified during routine quality monitoring activities. Trouble shoot problems when required and propose appropriate solutions Identify areas for improvements/efficiencies in existing processes and contributes to the Regulatory Information Management Systems (RIMS) Change Control Process Maintain knowledge of GSK standards and procedures associated with registration data management and contribute to the definition of new and revised procedures to improve quality and effectiveness Routine/ ad-hoc extraction and transformation of raw data from various Regulatory Information Management Systems (RIMS) for KPI generation in the context of data quality improvement and performance monitoring Knowledge/ Education / Previous Experience Required: 1. Minimum Level of Education – Poland: Bachelor’s degree or higher India & Mexico: Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment Area of Specialization – IT, Chemistry, pharmacy or other related science or regulatory affairs. Project Management, Communication Why is this Level of Education Required – Working in complex technical environment within a scientific organization 2. Preferred Level of Education – Poland: Bachelor Degree or higher India & Mexico: Masters degree or higher in biological or healthcare science Area of Specialization – IT, Chemistry, pharmacy or other related science or regulatory affairs. Project Management, Communication Why is this Level of Education Preferred- The ability to interact confidently with highly-educated staff, customers and partners in a complex technical environment will be a significant advantage in this role B. Job-Related Experience – Minimum Level of Job-Related Experience required : Minimum 4-5 years of experience in data and/or record management, handling user requests consistent and accurate completion of a significant number of data management tasks, including a broad range of regulatory procedures Demonstrated ability to proactively manage workload, timelines and identify priorities. Build relationships with relevant internal functions. Proven ability to work on multiple projects simultaneously. Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines Excellent written and verbal communication skills and ability to present information in a clear and concise manner Direct or indirect experience of regulatory processes associated with gaining and maintaining product registrations (for both Investigational and Marketed Products) and Regulatory Information Management Systems Ability to present and actively communicate Regulatory Archives requirements and policies and champion change. Why is this Level of Experience Required- Competency in the use of regulatory information management tools and sound understanding of the procedures and standards is required to work independently, quality check others’ work and supervise junior staff. C. Other Job-Related Skills/Background: Excellent attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines. Demonstrated ability to think flexibly in order to meet constantly shifting priorities and timelines. Strong interpersonal skills, service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment. Excel macro/pivot table skills is a plus Knowledge of records retention procedures and relevant regulations and business practices regarding regulatory document management. Demonstrates the following behaviors: Customer focus Enable and drive change Service orientation, customer-focused Ability to work carefully under time constraints and prioritize accordingly Good team worker Awareness of Regulatory Information Management Systems and their criticality to legislative requirements Application of Knowledge: Knowledge of the systems and related procedures used is required to efficiently complete tasks meeting requirements. Experience is used to advise users and to supervise, mentor and instruct junior staff Problem Solving & Innovation: Needs to be able to analyze inputs received to ensure they meet data standards prior to entry need to know when to question the requestor and ask questions about the data. Needs to recognize new situations which require revised procedure and contribute to its definition. Interaction: Will need to interface with requestors (who may be in any part of the organization) to gain clarity of work requested. Multi-cultural responsibilities that the role requires : Will interact regularly with colleagues and customers at the main GRC centers in US, UK, Poland, Belgium, Mexico, Cairo and India Role will interface with requestors globally. Impact: The information managed is critical to patient safety, regulatory compliance and effective business operations. The post holder is accountable for the quality and accuracy of their own work and for the support of the large number of other users across GSK. 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. 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Expected salary:

Location: Bangalore, Karnataka

Job date: Sat, 14 May 2022 22:27:04 GMT

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