Associate Director, Regulatory Affairs
2 weeks ago
About the job
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Key Responsibilities
- Clinical Trial Regulatory Submissions : Over 15 years of relevant experience in clinical trial regulatory submissions.
- Regulatory Leadership : Experience in managing clinical trial studies, serving as Regulatory Lead for global trials, with exposure to the European market.
- Database Expertise : Proficiency in handling the CTIS database and submitting EU CTR and CDSCO is desirable.
- Project Profitability : Monitor the profitability of multiple projects/programs through active involvement with project leads in preparing project plans and managing project budgets.
- Revenue Recognition : Proactively avoid and resolve issues with revenue recognition.
- Team Collaboration : Work within a team environment or individually based on project needs.
- Mentorship : Provide guidance to project team members and act as a mentor to staff.
- Issue Resolution : Work within broad project guidelines and lead issue and conflict resolutions.
- Workload Management : Prioritize own workload and the workload of the project team to achieve project scope and objectives.
- Efficiency Improvement : Capitalize on opportunities to improve project efficiency, results, or team performance and proactively take action.
- Performance Management : Actively manage performance, including typical HR activities for direct reports (e.g., performance management forms, salary actions, bonuses, scorecards).
- Staff Support : Provide input on staff to appropriate PC Members and support direct reports with the management of their staff.
- Guidance and Accountability : Provide applicable guidance and support to staff to succeed and achieve key metrics; hold staff accountable to key metrics.
- Staff Development : Facilitate staff development plans and coordinate with Strategic Resourcing staffing to ensure staff is utilized completely and appropriately to increase their expertise.
- Skill Expansion : Collaborate with strategic resourcing to provide staff with opportunities to expand skill sets.
- Recognition and Reward : Reward staff appropriately as needed.
- Leadership and Mentoring : Provide leadership, coaching, mentoring, feedback, and role modeling to managers and extended staff to ensure quality and accuracy of services as well as achievement of key metrics.
- Vision and Values Communication : Communicate and champion organizational vision and values.
- Effective Communication : Regularly communicate with staff to assure effective two-way information flow (e.g., business updates, staff interests, issues, and/or concerns).
- Consulting Services : Provide a full range of technical and/or business consulting services mainly in areas where policy or precedent is clear.
- Self-Development : Define self-development activities to keep current within the industry (e.g., maintain membership in a relevant industry and/or scientific/technical association).
- Project Efficiency : Capitalize on opportunities to improve project efficiency, results, or team performance and proactively take action.
- Information Leverage : Leverage information from previous projects or other client work to efficiently complete assigned project activities and facilitate business decisions.
- Quality Work : Produce quality work that meets the expectations of the client. Review the work of colleagues for content and quality to ensure client and PC expectations are met.
- Strategy Development : Assess project issues and develop strategies to meet productivity, quality, and project goals and objectives.
- Performance Management : Actively manage performance, including typical HR activities for direct reports (e.g., performance management reviews, salary actions, bonuses, scorecards)
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