Regulatory Affairs Consultant
Parexel · Taipei
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 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 as a 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