Job title: Regulatory Specialist II – RIM
Company: GlaxoSmithKline Pte Ltd
Job description: Job Description : Site Name: Field Worker – CHN Posted Date: Mar 16 2022 Key Responsibilities The information (data and documents) managed by Regulatory Information Management is critical to patient safety, regulatory compliance and effective busine
Job Description : Site Name: Field Worker – CHN Posted Date: Mar 16 2022 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. 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: Accurate completion of routine data maintenance tasks to agreed schedule Ensure own work 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. Capable of performing routine data extraction from RIMS to support KPI generation Maintain knowledge of GSK standards and procedures associated with RIMS and contribute to the definition of new and revised procedures to improve quality and effectiveness Indexing, abstracting and quality assurance of English and non english submissions and associated correspondence into established regulatory information management system(s). Supporting Legal and Business Development project work for document discovery, in-licensing, and out-licensing initiatives. Support customer requests, as needed, by conducting specific searches for proprietary regulatory information using on-line databases. Working on Special projects as required in response to internal and external customer requests. Support for IT related activities. Breadth/ Scope of Accountability* Provide details of any scope data relevant to the role e.g. the net sales that the role supports / generates or budget responsibility. .Minimum Level of Education Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment. Area of Specialization* Chemistry, pharmacy or other related science or regulatory affairs. Project Management, Communication. Job-Related Experience* 0-3 years’ experience in delivering business operational support (in pharmaceutical industry, life sciences research or regulatory). Have worked on regulatory submission, have fair knowledge on the CAPA and audit reports 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 written and verbal communication skills and ability to present information in a clear and concise manner Ability to think flexibly in order to meet constantly shifting priorities and timelines. Has worked successfully with a complex computer system Interacts with customers to ensure compliance with regulatory records and data management requirements 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. 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Location: Bangalore, Karnataka
Job date: Fri, 18 Mar 2022 23:36:29 GMT
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