Senior/ Regulatory Affairs Associate
求人ID R0000031452 Category Regulatory / ConsultingAbout this Role
Qualification
- Knowledge and Experience:
- A Senior Associate must have an understanding and experience of consulting models and methodologies
- A Senior Associate must have good knowledge of regulatory requirements of IND/CTA/NDA and have experience of filing clinical trial application or import license application successfully to health authorities.
- A Senior Associate shall have experience of taking a Technical SME for ensuring that client work is performed, and delivered on time, meeting the quality expectations of the client.
- A Senior Associate may act in a client facing role. When serving as a Project Lead or Work Stream Lead, a Senior Associate assures the work of the entire team or work stream is delivered on time and that it meets client’s and Parexel's quality expectations.
- More than 3 years of experience in regulatory affairs or SSU for clinical trials
- Education:
- Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline. BPharm degree is a plus.
Key Accountabilities:
Project Execution-
- Works effectively within a team environment but may work independently delivering services within their area of competence
- Works within broad project guidelines as directed by the project lead and/or technical SMEs
- Takes initiative to prioritize work to achieve specified project outcomes while confirming alignment with project lead and line manager
- May serve as a Project Lead or a Work Stream Lead. PL shall be responsible for project planning and set-up, till all project close-out activities are completed, which could include project delivery of scoped work, project financials, forecasts, training compliance, risk identification/issue escalation with solutions, etc.
Consulting Activities and Relationship Management
- Follows and implements the organization’s consulting models and methodologies under the guidance of the project lead and/or Technical SME
- Delivers consulting services within personal area of expertise under the guidance of the project lead and/or Technical SME
- Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability under the direction of the Project Lead and/or Technical SME
- Identifies project and internal issues to senior colleagues and Project Lead and/or technical SME and provides proposed solutions
Business Development
- Communicates potential new business leads to consulting management and account managers
- May participate in project scoping calls and/or proposal preparation with the support of senior colleagues
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