Regulatory Affairs Systems & Metrics Analyst, Open to flexible working
Are you a regulatory specialist with a proven background in supporting key regulatory processes to ensure regulatory, legal and pharmacovigilance obligations are met and exceeded? If so, read on...
GSK have a new role for a Regulatory Affairs Systems & Metrics Analyst on a full-time permanent basis.
As the Regulatory Affairs Systems & Metrics Analyst you will manage the regulatory information management (RIM) system for all GSK Consumer Healthcare products worldwide to support key regulatory processes and enable GSK to meet its regulatory, legal and pharmacovigilance obligations.
This role is responsible for the operation of the regulatory systems and processes used to prepare and store regulatory submissions, labelling, planning/tracking and generating KPIs/metrics and compliance reports.
This role will work closely with central, regional and key local regulatory GSK CH teams, and key external regulatory agencies/trade associations to ensure key information is provided to meet internal/external compliance databases (e.g. EU Art 57) and PV systems.
This role will proactively evaluate systems and processes and recommend improvement activities to enhance the speed of innovation delivery and deliver efficient compliance via targeted KPIs.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Identify and drive system or process changes to enhance data quality, user experience and compliance.
- Provide guidance and support for related initiatives, including system upgrades and enhancements in support of regulatory processes and obligations.
- Monitor system performance and ensure that performance or capability issues are resolved effectively.
- Partner with IT colleagues on system implementation and change control activities, including development of iQMS IT quality documentation to support user acceptance, including test scripts and reports.
- Manage the design, validation and delivery of regulatory reports for compliance and dept. KPIs.
- Ensure timely delivery of ad-hoc and regular reports.
- Ensure capture of high data quality regulatory data.
- Identify and communicate data errors and inconsistencies, and drive data remediation initiatives as required.
- Manage the delivery of compliance reports required to support business stakeholders.
User training and support:
- Delivery of effective system user training and system access promoting compliant use of RIMs application.
- Ensure up to date process documentation, training materials and user guides.
- Provide Systems Administration, including management of user access and roles.
- Provide day-to-day support to the users.
- Champion the importance of registration tracking within the organisation through regular communication with global stakeholders.
We are looking for professionals with these required skills to achieve our goals:
- Degree plus in a relevant area (Life Science, Computer Science or other related discipline)
- Experience within pharmaceutical organisation, in particular Regulatory Affairs. Understanding of global regulatory affairs processes.
- Familiarity with the range and types of non-prescription healthcare products, including over-the-counter (OTC) medicines, cosmetics and devices.
- Awareness/experience of EMA EudraVigilance, Medicinal Product Dictionary (EVMPD) requirements.
- Advanced knowledge of Regulatory Information Management.
- Familiarity with database applications, concepts and reporting.
- Experience of project and business analysis.
- Excellent understanding of standard IT applications, including advanced use of Microsoft Excel to manipulate reports and summarise data.
- Knowledge of Veeva Regulatory Vault application.
- Familiarity with systems validation and project quality methodologies (e.g. iQMS).
- Clear and accurate editorial skills to ensure data reported is consistent and meaningful.
- Excellent organisational and coordination skills.
- Excellent analytical and problem-solving skills.
- Good communication skills, focusing on customer requirements
APPLICATION CLOSING DATE - 11th MAY 2021
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best.
When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you are being motivated to do your best work, in a place where you can be you, feel good and keep growing.
Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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.