Clinical Transparency Lead
2 weeks ago
Key Responsibilities :
Active contributor to cross functional and global projects impacting the process. Maintain awareness of the external environment and ensure GSK contributes to external discussions around any changes. Build relationships and trust with the people in the business who are accountable for delivering the documents for the regulatory process. Work closely with System Support and IT, ensuring that for all systems required to support the process issues/upgrades/enhancements and management of system bugs are addressed in a timely manner, with minimal impact to the users. Maintain any process documentation and training materials for the relevant process. Ensure appropriate user training exists for the related systems, initiating training reviews and updates as required. Check that staff contributing to the process have received the appropriate training. Participate in both internal and external audits with respect to the process and respond to any findings Develop reports and alerts to ensure relevant managers are aware of compliance to quality and timelines. Ensure that external partners who provide support the transactional parts of the processes are suitably trained and deliver to the required policy.Education Requirements
Bachelors degree in Life Sciences or related discipline; postgraduate degree preferred- a minimum 6 years clinical developmentexperienceJob Related Experience
Good understanding of R&D and the clinical development process Good negotiation and influencing skills Good team-working skills with ability to work with a high degree of independence when required Demonstrable ability to provide first rate customer service Ability to effectively manage conflicting demands in a high pressure, constantly changing environment Excellent verbal and written communication skills Experience of providing informal or formal support to a diverse user community Knowledge/awareness of GSK systems impacting the regulatory processes Experience in a regulatory requirements is an advantage Experience of interfacing with GSK senior managers Hands-on experience of one or more regulatory processes at GSK and using the systems supporting the processWhy 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.
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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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