GSK
Website:
gsk.com
Job details:
Job Purpose
The information (data and documents) managed by Regulatory Information Management & Data Office is critical to patient
safety, regulatory compliance and effective business operations. Regulatory Information Management & Data Office are
responsible for the accurate encoding of GSK product (Pharmaceuticals and Vaccines) registration information and maintaining
regulatory records to a high 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: Describe the key deliverables to be achieved by the post holder and the ongoing
responsibilities of the role.
- 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
- 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
- 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 Health Authority (HA) submissions and associated correspondence into
established regulatory document management system(s).
- Support customer requests, as needed, by conducting specific searches for proprietary regulatory information using on-line
databases.
- 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
- Working on projects as required in response to internal and external customer requests.
- Trouble shoot problems when required and propose appropriate solutions
- Supporting Legal and Business Development project work for document discovery, in-licensing, and out-licensing initiatives.
- GQA Activities (where applicable)
- 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
- Ensure CQA and PVQA data is entered accurately into the audit management system and within the required
timelines working on Special projects as required in response to internal and external customer requests.
Skills
Communication, Digital Fluency, Pharmaceutical Regulatory Compliance, Regulatory Strategies, Stakeholder Management
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Inclusion at GSK:
As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.
Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.
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.
It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.
GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.
If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.
Click on Apply to know more.