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.
- Import license application(시험용 의료기기 확인서) 및 변경/보고 관리
- Tracker 및 데이터베이스 관리 및 팀 회의 조율 등의 Team support 업무
- 경력자 또는 신입 고려 가능
- Chemistry, Biology, Pharmacy 혹은 그 외 유관 전공 학사 이상
- 오피스/재택 근무 병행
Key Accountabilities:
Project Administration:
- Under supervision provide basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumization, pagination, and formatting of reports and simple submissions.
- Provide basic regulatory affairs services including preparing submission packages Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
Document Management:
- Under supervision perform basic document management tasks including file transfer, storage, tracking, and archival of Regulatory Guidelines
- Develop a familiarity with current global regulatory submission standards.
Standard Operating Procedures:
- Develop a familiarity with departmental standard operating procedures and work instructions.
Product Support:
- (Regulatory Affairs only) Under supervision provide support to currently marketed products.
Skills:
Project Execution:
- Works effectively within a team environment.
- Works within broad project guidelines as directed by the project Technical Lead or Project Manager.
- With the guidance of the project Technical Lead or Project Manager, demonstrates the ability to prioritize work to achieve specified project outcomes.
- Capitalizes on opportunities to improve performance and seeks feedback from the project Team Lead and colleagues.
- Applies information provided by the project Team Lead or senior colleagues to complete assigned project activities.
- Produces quality work that meets the expectations of Project Lead and the client.
Relationship Management:
- Completes assigned activities within project scope and objectives under the direction of the Project Lead.
- Identifies project and internal issues to senior colleagues and Project Lead.
- Interacts professionally at all working levels within a client organization and within Parexel.
- Identifies project and/or client needs to the Project Lead.
Parexel-Related Responsibilities:
- Meets established metrics as specified in scorecard on an annual basis.
- Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management.
- Defines self-development activities with the support of management to keep current within the industry.
Knowledge and Experience:
- 0-2 years’ experience in an industry-related environment.
Education:
- Bachelor’s Degree in a Scientific or Technical Discipline.
Top Skills
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
