GSK - Associate - Regulatory Publishing (3-5 yrs)
- Responsible for the publishing of centrally supported regulatory dossiers for regulatory affairs category teams, either for direct submission to regulatory authorities, or for submission via local regulatory teams.
- Responsible for the publishing of R&D clinical study reports for the medical operations team.
- Participate in publishing activities and resource management of all assigned submissions/reports/documents in compliance with internal and external publishing quality standards. Works in a collaborative effort with regulatory associates from central function and LOC to ensure assigned submission work is accomplished to agreed timings.
- Prioritize publishing work on dossiers and study reports in order to meet agreed regulatory targets. Work may be self-prioritized or may come from a more senior-level person in the group as part of a larger work plan.
- Develops good working relationships with internal and external customers to facilitate effective communication and to ensure that customers adhere to publishing quality expectations and timelines with respect to the submission assembly and publication process.
- Supports regulatory & medical customers to resolve publishing related issues, with support from senior management as required.
- Provides advice and guidance on the production and publishing of regulatory submissions to R&D project teams, and regulatory affairs directly, to agree approaches and timelines for the supply of submission documents and data for submission preparation.
- Contributes (as per assigned goals) to the evolution of publishing capability, including system enhancements, best-practice process improvements and regulatory intelligence.
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