GSK

Regulatory Information Management Administrator

Employer
GSK
Location
Research Triangle Park, North Carolina; Cambridge, Massachusetts; Collegeville, Pennsylvania
Salary
Competitive
Posted
July 22 2021
Ref
298730
Organization Type
Pharma
Site Name: Belgium-Wavre, UK - London - Brentford, USA - Massachusetts - Cambridge, USA - Pennsylvania - Upper Providence, USA - North Carolina - Research Triangle Park Posted Date: Jul 22 2021 The role of the Regulatory Information Management (RIM) team is to establish and embed a fully harmonised global team supporting the GSK portfolio of products, enabling the delivery and support of Regulatory Information Management (RIM).This includes: • Enabling the execution of the various regulatory processes (including maintaining awareness of external environment) • Ensuring the timely update of compliant data and record keeping requirements is adhered to • Delivering data quality and integrity whilst continuously seeking innovative opportunities to improve ways of working, business efficiency and drive automation. 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. Position Holder (PH) will continuously educate customers on best practice with regards to GRA systems and processes and (on a continuous basis) will feed back suggestions for improvement. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: • Coordinate data collection and reporting process for compliance with timelines for delivery of labelling updates with partners at global, regional, and local levels • Manage data collection, report dissemination, and follow-up for flagged events within an agreed schedule • Support the building of a tool and process for setting up baseline data, resource tracking, and forecasting • Work with Global Labelling teams to improve visibility and access to performance data • Assist the management team with reports to address performance queries (related to source data) and work with functional group to identify root causes of deviations, or ingredients of success • Support the system administration of the labelling systems, including training of global and local users, in accordance with GSK policies and procedures • Work closely with IT Business System Owners to coordinate solutions delivery and support, such as User Acceptance Testing • Support development and maintenance of labelling websites, Team sites, and other communication channels • Participate in other projects and activities that support other labelling functions, such as contributing to the implementation of changes to processes within Global Regulatory Affairs (GRA) • Escalate risks and variances from plan or target when appropriate Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in Life Sciences or Engineering discipline 1 year experience in Regulatory Information Management Systems and Processes in-use within Global Regulatory Affairs, requiring a deep understanding of the Regulatory Vault data model and legacy RIM systems 1 year experience supporting end users of RIM systems and processes to enable efficient ways of working including: provide basic guidance, adhoc training, attendance at group meetings, provision of appropriate Reports etc 1 year experience streamlining regulatory information communication to Manufacturing and/or QA Release stakeholders to facilitate Supply Chain and QA Release operations•Ensuring appropriate procedures are followed in the maintenance of System Reference Data Preferred Qualifications: If you have the following characteristics, it would be a plus: Master's degree Excellent verbal and written communications skills Ability to work carefully under time constraints and prioritize accordingly Adaptable to fast-paced environments with changing circumstances, direction, and strategy Exposure to work within a regulated environment, ideally in drug development Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 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. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

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