Manager, Regulatory Affairs

September 15

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+

💰 Venture Round on 1990-01

Description

Requirements

• 10+ yrs relevant experience in Clinical Trial Regulatory Submissions. • Experience in managing clinical trial studies, playing Regulatory Leads for Global trials, and exposure to the European market. • Expertise in handling the CTIS database and submitting EU CTR is desirable. • Provides guidance to project team members. • Works within broad project guidelines and facilitates issue and conflict resolutions. • Prioritizes own workload and may prioritize the workload of the project team in order to achieve the project scope and objectives. • Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action. • Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions. • Produces quality work that meets the expectations and the client. • Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC are met. • Assesses project issues and develops strategies to meet productivity, quality and project goals and objectives. • Actively manages performance including typical HR activities for direct reports (i.e. performance management reviews, salary actions, bonuses, scorecards). • Assures PAREXEL policies and procedures are communicated to line personnel in alignment with their staff’s local country. • Provides a full range of technical and/or business consulting services mainly in areas where policy or precedent is clear. • Defines self-development activities in order to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association).