Regulatory Affairs Consultant - Core Team

Experience in Quality Documentation and CMC (Composition, Manufacturing and Control of Investigational Medicinal Products) could be a plus.

Key Accountabilities:

Project Execution

• Typically works within a team environment but may work independently delivering services within their technical area of expertise
• Works within broad project guidelines but liaises closely with more senior colleagues to discuss issues and resolve conflicts
• Demonstrates ability to prioritize work and define steps needed to achieve specified project outcomes
• Capitalizes on opportunities to improve one’s own performance and may provide suggestions for improving project efficiencies and results to the project technical lead
• Seeks out information from previous projects, other client work or from colleagues to complete assigned project activities
• Produces quality work that meets the expectations of project Team Lead and the client
• May serve as a Project Lead for small scale projects or a Work Stream
• Lead on larger projects When serving as a Project Lead
• 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
• Provides technical and/or business consulting services within personal area of expertise
• Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability
• Collaborates with colleagues and client to identify and resolve technical and process issues
• Leverages senior colleagues to discuss and propose resolutions to possible problems or conflicts. Seeks guidance periodically on appropriate methods of executing project activities
• Interacts professionally at multiple levels within a client organization and within Parexel
• Proactively assesses client needs and develops processes and solutions to address issues
• Delivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided
• Interactions result in clients expressing satisfaction with service provided
• May prepare and/ or deliver presentation with the support of senior colleagues
• May deliver training
• Mentor of junior staff
• 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 senior 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 or asa mentor 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
• Consulting 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:

• Several years of experience in an industry-related environment

Education:

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