Senior Regulatory Affairs Associate

A Senior Associate must have an understanding of the organization’s basic consulting models and methodologies, as well as basic knowledge of what services PC provides. He/she must be technically competent and continually developing the skills as defined in the key accountabilities section of this document. Also, under the general direction of a Project Lead and/or Technical SME, takes responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of PC and the client. This role may act in a client facing role with support from line management. 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 PC’s quality expectations.

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 PL and LM.
• Capitalizes on opportunities to improve one’s own performance and seeks feedback from the PL and colleagues.
• Applies information provided by the PL or Sr. colleagues to complete assigned project activities.
• May serve as a Project Lead for small scale projects or a Work Stream Lead on larger projects.
• Responsible for project planning and set-up and routinely interacts with the assigned Project Specialist (PS) or Project Manager (PM) to appropriately control the project (e.g. project set-up, forecasting and financial entries, invoicing, etc.).
• Functions as the main client contact and ensures accurate project reporting is in place. Ensures that the project team delivers to meet the client expectations for quality and timeliness.
• Ensures that appropriate risk identification and issue-escalation procedures are in place.
• Ensures project specific training compliance of the project team.
• Ensures and/or manages project financials including provision of accurate revenue forecasts.
• Ensures that the project team understand and work to the scope of the contract.
• Identifies new opportunities through Change In Scope or add-on business from existing work.
• Ensures timely project close-out activities are completed.

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.
• Interacts professionally at all working levels within a client organization and within PAREXEL.
• Identifies project and/or client needs to the Project Lead and or Technical SME and collaborates with senior staff to define a proposed solution.
• Interactions result in clients expressing satisfaction with service provided.
• May assist in preparing and/ or delivering a presentation.
• Identifies and alerts PC management to opportunities for follow-on business or necessary changes in project scope.

Business Development:

• Continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experience.
• Communicates potential new business leads to PC management and account managers.
• May participate in project scoping calls and/or proposal preparation with the support of Sr. colleagues.

PAREXEL-related Activities:

• Meets established metrics as specified in scorecard on an annual basis.
• Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, training compliance, project deliverable archiving, participation in internal initiatives/projects as requested by management.
• 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).

Skills:

• Project management knowledge.
• Client-focused approach to work.
• Results orientation.
• Teamwork and collaboration skills.
• Excellent interpersonal and intercultural communication skills, both written and verbal.
• Critical thinking and problem-solving skills.
• Proficiency in local language and extensive working knowledge of the English language.

Knowledge and Experience:

• Few years of experience in an industry-related environment

Education:

• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline