Posted Date: Dec 5 2019
Are you looking for an opportunity to support a regulatory environment where you will be a part of Global labelling initiatives and Timely maintenance of Global and regional/country Product Information (PI), including information for healthcare professionals and patients. Provides expertise and support to LOCs with respect to Global PI processes and responses to Regulatory Agency questions about PI.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Efficient management of updates to Global PI including: leading the functional experts to generate content, authoring identified sections of the Global PI, presentation of items at Global Labelling Committee, and ensuring compliance with associated timelines.
- Efficient maintenance of country/regional labelling in compliance with GSK Labelling processes and external requirements such as management of the International PI document, US PI and EU PI (for Centralised, Mutual Recognition and Decentralised procedure submissions)
- Act as subject matter expert in GSK Global Labelling process and/or US/EU product information requirements.
- Support the LOCs in the implementation of Global PI text into country PI.
- Author responses to Regulatory Agency questions about PI.
- Authoring documentation to support the Global Labelling Committee Secretariat, as required.
- Effective planning, prioritization, communication and delivery of quality labelling documents according to company timelines and submission requirements.
- Train/coach others, as required.
- Participation in other projects and activities, such as leading implementation of changes to labelling processes.
We are looking for professionals with these required skills to achieve our goals:
- 7-9 years relevant experience (in Global labeling at pharmaceutical industry ).
- Successfully performed within a regulated or quality-critical environment such as pharmaceutical industry research or regulatory).
- Attention to detail, excellent organization and time management skills.
- Excellent written and verbal communication skills and ability to present information in a clear and concise manner
- Ability to think flexibly in order to meet constantly shifting priorities and timelines and to independently provide solutions to issues.
- Well-developed understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
- Well-developed understanding of labelling (e.g. significant experience in managing local labelling documents/submissions and/or management of global labelling documents).
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
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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 GlaxoSmithKilne (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 firstname.lastname@example.org, so that we can confirm to you if the job is genuine.