Country Approval Specialist (SSU)

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

Country Approval Specialist (SSU)

• Work condition: (1) Fully Remote (2) Hybrid (3) Fully Office - Gangnam, Seoul
• Type: Regular (정규직)
• Team: Country Approval Team

What will you do?

• Participates in the management and preparation, review and coordination of Country Submissions in line with global submission strategy.
• Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
• Provides project specific local SIA services and coordination of these projects.
• May have contact with investigators for submission related activities.
• Key-contact at country level for either Ethical or Regulatory submission-related activities.
• Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
• Achieves PPD’s target cycle times for site.
• May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
• May develop country specific Patient Information Sheet/Informed Consent form documents.
• May assist with grant budgets(s) and payment schedules negotiations with sites.
• Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
• Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
• Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
• Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Qualifications

• Over 1+ years of study start up experience.
• IRB Submission experience.
• Covering Initial study experience are preferred.
• Bachelor's degree or above
• Academic background in Life Science, Nursing, Biology, Pharmaceutical Science are preferred.

기타사항

• 지원 과정에서 아래 사항에는 해당이 될 경우에만 Yes로 체크해주시기 바랍니다. -(1) 써모피셔 사이언티픽 과거 또는 현재 재직여부 (2) 합병 관계사 재직여부 (3) 장애여부(disabled) (4) 보훈대상여부(veteran) (5) VISA Sponsorship 지원 필요 여부 (6) U.S. 연방정부 기관 근무 여부 (7) 고용 및 이직에 제한사항 여부
• 고유식별정보(주민등록번호, 여권번호 등) 민감정보(종교, 정치 등)는 기재하지 마세요.
• 보훈, 장애 대상자는 관련 서류 제출 시 관계법에 따라 우대합니다.
• 영문이름은 여권상의 이름과 동일하게 기재하십시오.
• 입사지원서 내용에 허위 사실이 판명될 경우, 입사가 취소될 수 있습니다.

For more Thermo Fisher Scientific Korea

•YouTube

•Learn more about us here

•Official Recruiting Blog (Korean)

• Our 4i Values:

Integrity – Innovation – Intensity – Involvement

• Our Mission:

Our Mission is to enable our customers to make the world healthier, cleaner and safer.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.