Regulatory Specialist, Regulatory Information Management
1 miesiąc temu
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.
In this role you will….
Be responsible for accurate completion of more complex or non-routine data maintenance tasks to agreed schedule
Supervise, 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
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
Why you?
BASIC REQUIREMENTS:
Min Bachelor’s degree from preferably: IT, chemistry, pharmacy or other related science or regulatory affairs, Project Management, Communication area
Minimum 2-3 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
Competency in the use of regulatory information management tools
Proven ability to work on multiple projects simultaneously and demonstrated organisational skills
Excellent written and verbal communication skills in English and Polish, and ability to present information in a clear and concise manner
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 would be a plus
Knowledge of records retention procedures and relevant regulations and business practices regarding regulatory document management.
Customer Focus, Enable and drive change, Service orientation, customer-focused
Awareness of Regulatory Information Management Systems and their criticality to legislative requirements
We also offer a wide range of additional benefits:
Career at one of the leading global healthcare companies
2/3 days per week form the office
Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
Life insurance and pension plan
Private medical package with additional preventive healthcare services for employees and their eligible.
Sports cards (Multisport)
Possibilities of development within the role and company’s structure.
Personalized learning approach (mentoring, online training’ platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)
Supportive community and integration events
Modern office with creative rooms, fresh fruits every day
Inclusion and diversity at GSK are key for our success. Here, you will thrive through bringing your unique experiences to both our company and the recruitment process. We want you to be you, feel good and keep growing your career.
GSK is an Equal Opportunity and Affirmative Action Employer. Applicants will travel through a transparent recruitment journey that adheres to all required employment standards and regulations. Beyond this, we commit to our values of integrity and respect towards every applicant.
We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team ( ) to further discuss this today.
We will request equal opportunities information from you and whilst disclosure is optional, we encourage you to be open, enabling us to monitor the inclusivity of our recruitment practices for the benefit of everyone. Your data will remain confidential, is never shared with our Hiring Managers and never affects the status of your application. *Local restrictions/legal requirements
#LI-GSK
#LI-Hybrid
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.
GSK is an Equal Opportunity/Affirmative Action Employer. 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.
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