Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Senior Regulatory Affairs Associate
Job ID R0000037342 Taipei, Taiwan, TaiwanKey Accountabilities:
Act as primary RA representative for local Commercial and medical team: adopt a business perspective, explore opportunities and translate this thinking into actionable plans that fit with strategy.
Assess and mitigate impact of changes with local team
Project Execution
Support post-approval regulatory activities, including submission and management of post-market variations to ensure ongoing compliance of marketed products.
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
Capitalizes on opportunities to improve one’s own performance and seeks feedback from the project lead and colleagues
Applies information provided by the project lead or senior colleagues to complete assigned project activities
Produces quality work that meets the expectations of project lead and the client
May serve as a Project Lead for small scale projects or a Work Stream Lead on larger projects, and would be 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 with the support of senior colleagues
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 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
Recently Viewed Jobs
You have not recently viewed any jobs
View all jobs