Regulatory Document Migration RIM Sr Specialist - #7835169

The purpose of this hybrid role is to support planning, execution and verification of document migration for different taxonomies (e.g., Clinical, Nonclinical, Quality and Regulatory) from SharePoint, shared drives or Veeva Vault to GSK’s Regulatory Vault associated to acquisitions, in-licensing or divestments for investigational and marketed assets (Pharmaceuticals and Vaccines) from other companies.

Your Responsibilities: This role gives YOU the opportunity to lead key activities to progress YOUR career, the main of these are:

• Manage and support the different stages for document migration from SharePoint, shared drives or Veeva Vault to GSK repositories (Veeva RIM, Corporate Archive). Activities may include: analysis, data mapping, risk identification, ingestion, reporting, and document authoring (i.e., Data Migration Plan, Data Migration Report).

• 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 and/or record maintenance tasks to agreed schedule, including document migrations. Leading external document integrations into the appropriate libraries and taxonomies (Clinical, Nonclinical, Quality, Regulatory, etc.)
• Ensure own work and that of junior colleagues is compliant with data standards and defined procedures
• Ensure defined quality control procedures are followed.
• 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 RIMS 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
• Coordinate the indexing and abstracting of all types of FDA submissions and associated correspondence into established regulatory document management system(s). Ensure the ability to retrieve, view and print archival documents. Work independently with very little mentoring support required from other experts or managers.
• Manage existing document management systems and databases used to track and/or archive submissions to the FDA, correspondence from the FDA and associated internal memos and communications, in both paper and electronic format.
• Manage and lead legal document discovery by assisting with file integrity checks and assuring the provision of copies of documents in compliance with FDA regulations and established policies and procedures.

Why you?

Basic Qualifications: We are looking for professionals with these characteristics to achieve our goals:

• Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment
• Minimum 4 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
• ETL experience: Data Exporting, Transforming, Loading within a pharmaceutical organization (Clinical, Nonclinical, Quality, Regulatory mapping)
• Ability to adapt transformation of document metadata based upon the available information into VeevaRIM libraries and metadata taxonomies
• 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
• Advanced English Level.
• Excellent organizational 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 in English and ability to present information in a clear and concise manner

Preferred Qualifications: However, if you have the following, it would be a plus:

• Excel savvy with Power Query knowledge
• Veeva RIM
• Master’s degree or higher in biological or healthcare science

If you feel this is your next career move, please apply up to July 15th, 2024.

Why GSK?

Uniting science, technology and talent to get ahead of disease together GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we 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 we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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.

Our inclusive workplace makes our employees feel engaged by the contribution they make, by affording them equal treatment regardless of actual or perceived characteristics. As so, when you apply for a job at GSK, it is not necessary to include on your resume information such as: race, color, ethnicity, age, gender, sexual orientation, marital status, religion, origin, photographs or any other personal characteristics.