GlaxoSmithKline Pharmaceuticals is looking to hire Consultant-NCE Submission Coordinator .Interested and eligible candidates can send their resume…GlaxoSmithKline is one of the world’s leading pharmaceutical and healthcare companies, with statisticians and programmers working at UK and US R&D sites, and worldwide. In recognition of the developing sophistication and technical requirements of the programming role, the Clinical Programming department was formed as a standalone department within the broader Clinical Statistics group 18 months ago, covering all phases of clinical drug development and commercialization in a wide range of therapeutic areas. In addition to the group’s activities supporting GSK’s pipeline of drugs, key accountabilities include driving CDISC implementation for the reporting of clinical trials, and identifying and implementing technology solutions to offer further benefit and efficiency for the group’s activities.
…The eligibility criteria as follows.
Vacancy details :
|Company Name||: GlaxoSmithKline Pharmaceuticals|
|Designation||: Consultant-NCE Submission Coordinator|
|No. of Vacancies :||:04|
|Salary||: Not Disclosed|
- With management oversight, accountable to deliver to Project Lead or GRL/ Regional Rep/ C&EP lead for delivery of assigned submissions to agreed timeframes and appropriate content
- Will require to have technical expertise for EU and EMAP markets guidelines
- Beginning to understand internal/external CMC Regulatory environment
- Begin to build organisational networks.
- Regular communication with line manager or technical lead to help identify any technical issues with business impact.
- Manages routine project assignments with some level of support from manager
- With management oversight, ensures quality of both own and submission team work and compliance with regulatory guidelines and process as they apply to the role.
- Works with staff from other functions and should be capable of working to senior levels in development functions in provision of advice, interpretation of relevant guidance’s, researching topics and resolving issues.
- May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities.
- May be responsible for the life cycle maintenance activities associated with an approved product, including product renewals, label harmonization, PBRER submissions etc
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