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sales @PT Mitsubishi Motors Kramayudha Indonesia2021 ~ Present
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Administrator, Virtual Assistant, Customer Service
Within one month
indah marketing My name is Indah, I am a dedicated professional with experience in the field of Marketing and Digital Marketing. I have an educational background in Information Systems and have worked in various companies where I have developed strong skills in the World of Marketing. During my career, I have been involved in various projects involving Marketing and have managed to achieve significant results. I am confident in my abilities for Digital Marketing-Web Design -Translation(Eng-Eng) -Image Editing, as well as collaborating with a team to achieve common goals.In addition, I am
Employed
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Ready to interview
Part-time / Interested in working remotely
10-15 years
Institut Teknologi Sepuluh Nopember
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sistem informasi
OPC Chief Engineer @TSMC2020 ~ Present
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AI工程師、機器學習工程師、深度學習工程師、資料科學家、Machine Learning Engineer、Deep Learning Engineer、Data Scientist
Within one month
Chun-Jung Huang [email protected] Chiao-Tung University, Ph.D. - Photonics,2015 ~ 2020 Member of The Phi Tau Phi Scholastic Honor Society of the Republic of China. Work Experience TSMC, OPC Chief Engineer (MarPresent) ◆Introduced image anomaly detection techniques to identify and address defects in photomask manufacturing, significantly improving product quality and reducing turnaround time. ◆Managed large-scale data processing tasks, demonstrating expertise in analyzing and handling datasets of hundreds of millions, to bolster model development and optimization. ◆Excelled in distributed computing, optimizing code execution across thousands of systems to
Employed
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Ready to interview
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4-6 years
National Chiao-Tung University
・
Ph.D. - Clinical Engineering
Senior HR Executive @Cosmic Indonesia2023 ~ Present
・
Human Resources
Within one month
that goes Live Responsible for checking and approving reimbursement and general expenses of Indonesia employees End-to-end recruitment process Maintaining employment contracts of employees (PKWT/PKWTT) Onboarding new joiners (all countries) then preparing Induction Programs (Physical and Vessel Induction) Preparing Townhall presentation for HR updates and doing a translation for Indonesia employees Onboarding employees who merged with our holding companies Responsible for the retaining programs and employee wellness Traveling to our branch office and handling the employee's dispute HR Consultant (3 months contract) Simbadda Group • JanuaryMarch 2023 Responsible for managing and updating company regulations such as SOP
Employed
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4-6 years
Universitas Katolik Soegijapranata
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Bachelor's of Psychology
Staff Software Engineer @全得資通有限公司2019 ~ Present
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Staff software engineer
Within one month
Employed
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Full-time / Interested in working remotely
6-10 years
The University of Auckland
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Computer Science
Sales Control Coordinator @Bosch Taiwan2018 ~ Present
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Operation Specialist/Logistics Specialist
Within one month
Annual team building arrangement Sales Assistant • Eclat Textile Co. AugustMay 2014 | New Taipei city, Taiwan Outdoor brand customers garment orders processing Achieved export delivery in time for special sport events rush orders Trouble shooting for garment dying quality issue Intern • Bluesign Technologies AG JulyAugust 2011 | St. Gallen Switzerland Translation for yearly conference customer data and invitation Department supporting Education • Taiwan Tunghai University 東海大學 Foreign Language and Literature Department bachelor's degreeSkills Computer: Microsoft office Word/Excel/PowerPoint/OneNote ERP: SAP SD and MM module Languages Mandarin: Native English: Fluent level Japanese: Basic
Employed
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10-15 years
Tunghai University
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外國語文學系
Manager of Quality Management @Liberty Resources2024 ~ Present
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DEI Director
Within one month
Pascale Vallee, MPH Manager at Quality Management, Liberty Resources Inc// [email protected] With nearly a decade of proven leadership and program management, and with a background in rhetoric, pedagogy, and public health, my strengths and passions position me to excel in areas such as public speaking; program design, management, implementation, and evaluation; data analysis; knowledge translation; talent development; as well as diversity, equity, and inclusion (DEI) initiatives. https://www.linkedin.com/in/pascale-vallee Work Experience Liberty Resources 2015-present Liberty Resources, Inc. is a
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6-10 years
Drexel University Dornsife School of Public Health
Past
Frontend Software Engineer @foodpanda2022 ~ 2023
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前端工程師、全端工程師
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Unemployed
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Full-time / Remote Only
6-10 years
國立中山大學
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資訊管理Past
Team Leader @TaskUs 美商泰優股份有限公司台灣分公司2018 ~ Present
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Team Leader
Within two months
Unemployed
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4-6 years
淡江大學 Tamkang University
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法文
工程師
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server 規劃建制 Software Engineer，FringeBacker，台北 / Remote 2018 年 6 月年 10 月 - Django 網站功能 refactor - 將商業邏輯進行重構, 移除冗餘的程式碼 - API 文件撰寫 - unit tests - Django translation - 多國語系翻譯 Backend developer，環球誠信，高雄 2017 年 3 月年 4 月 - Django 建立 RESTful API - MySQL 效能調整 index - 網站 API 文件建立 ( use aglio) - 網站功能 refactor - 新舊報
Unemployed
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Full-time / Interested in working remotely
6-10 years
高雄應用科技大學
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電機系
Tutor Prodi PGSD dan Teknologi Pendidikan - Universitas Terbuka @Universitas Terbuka2022 ~ Present
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English Teacher
Within three months
Aji Budi Rinekso English Language Instructor Indonesia An experienced English language instructor for several programs including TOEFL, IELTS, General English, and Grammar-Writing. Additionally, I am open for qualitative data analysis, journal article review, proofreading, translation (English - Indonesia and vice versa), and research project collaboration/assistance. Pengalaman Kerja Tutor Prodi PGSD dan Teknologi Pendidikan - Universitas Terbuka • Universitas Terbuka OktoberPresent Menyusun materi, melaksanakan proses pembelajaran, dan melakukan asesmen pada mata kuliah Teknik Penulisan Karya Ilmiah, Strategi Pembelajaran Sekolah Dasar, dan Karya Ilmiah. TOEFL Instructor - (Online) • TOP ENGLISH AgustusPresent Assisting participants across various backgrounds including university students, lecturers
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4-6 years
Universitas Pendidikan Indonesia
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Senior regulatory affair specilalist
Exfluency
・
2022 ~ Present
Professional Background
Current status
Employed
Job Search Progress
Ready to interview
Professions
Pharmacist, Biotechnology Researcher, Translator
Fields of Employment
Medical Devices
Work experience
4-6 years
Management
Skills
Languages
English
・
Professional
Job search preferences
Positions
法規人員、臨床試驗專員
Job types
Full-time
Locations
Remote
Interested in working remotely
Freelance
Yes, I freelance in my spare time
Educations
School
National Cheng Kung University
Major
Pharmacology
Yu-Ru Chen
With a Bachelor's degree in Pharmacy and a Master's degree in Pharmacology, I have established a robust foundation in regulatory frameworks and essential medical concepts relevant to clinical practices.
Over the course of my career, I acquired significant expertise in clinical studies. As a medical writer for a Contract Research Organization (CRO) for two years, I actively contributed to the design and execution of Bioavailability/Bioequivalence (BA/BE) studies, as well as Phase I and Phase II trials. Following this, I transitioned to the role of a primary clinical reviewer at the Center for Drug Evaluation, where I spent two years critically assessing and reviewing new drug applications. In this capacity, I gained valuable insights into the regulatory landscape, specifically in evaluating clinical trial results encompassing efficacy and safety assessments, as well as conducting thorough risk and benefit evaluations.
Additionally, I played a pivotal role in the translation of technical documents, including Informed Consent Forms (ICF), Comprehensive Study Protocols (CSP), Clinical Study Reports (CSR), and various guidelines pertinent to clinical study projects. This multifaceted experience has equipped me with a comprehensive understanding of the intricacies of drug development, regulatory compliance, and effective communication within the pharmaceutical industry
Working Experience
Senior regulatory affairs specialist • CMIC Holdings Co., Ltd.
Feb 2022 - Present
1. Wrote a customized regulatory gap analysis report on oncological drugs for NDA submission
2. Support writing a BSE report (Oncology drug) and constructing the BSE data for BSE submissions, and getting BSE conditional approval
3. Draft NDA con
3. Completed a NDA submission and get a license in HK
Primary Clinical Reviewer • Center of Drug Evaluation
2020 - 2022
1.Wrote review reports to anaylsis 5-6 NDAs (monoclonal antibody for oncology, anti-diabetic drug, anti- psychotics drug) effcacy and safety for TFDA to make a decision.
2. Wrote evulation reports for 6 post-market surveillance reports for safety issues(oncology).
3. Wrote briefing analysis for each SUSAR and analyzed the investigation drug's safety profile.
4. Wrote anaylsis reports of Risk management plans/reports and provided regulatory perspective comments to the applicants
Medical Writer • Protech Pharmaservices Corporation
2018 - 2020
1. Wrote/Designed 20 the study protocols and reports for bioequivalence studies under various countries' regulatory requirements.
2. Wrote/Designed clinical study reports for Phase I/II oncology trials
3.Prepared/Wrote essential documents for IRB and authorized agency submissions, including study synopses, informed consent forms, and response to reviewers.
4.Translated ICFs/synopsis of CSPs/CSRs for various clinical studies.
Pharmacist • Hanming Christian Hospital
2013 - 2015
1. Dispensed medications by compounding, packaging, and labeling pharmaceuticals.
2. Pharmacy service includes preparing medications, giving pharmacological information to multidisciplinary health care teams, and monitoring patient drug therapies.
3. Provided pharmacological information by answering questions and requests of health care professionals and counseling patients on drug therapy.
Master Degree. 2015 - 2017
National Cheng Kung University
Pharmacology
Bachelor's Degree. 2008 - 2013
China Medical University
Pharmacy
Publication Article
- Chen, Y. R., Li, Y. H., Hsieh, T. C., Wang, C. M., Cheng, K. C., Wang, L., Lin, T. Y., Cheung, C-H et.al., Aging-induced Akt activation involves in aging-related pathologies and Aβ-induced toxicity. (2019) Aging Cell.18, 4.
- Ji XR, Cheng KC, Chen YR, Lin TY, Cheung CHA, Wu CL, Chiang HC. Dysfunction of different cellular degradation pathways contributes to specific β-amyloid42-induced pathologies. (2017) Molecular Neurobiology
Skills
- Documentation abilities
- Pharmacokinetic knowledge
- Regulatory requirements
- Medcial Writing
- Academic English writing
- Exceptional problem solver
Certification
- English :Professional lvel
- Pharmacist of higher examination 2013/09
- Design and Interpretation of Clinical Trials 2020/06
- SDL Trados Studio for Translators_Level 1 2021/11
Yu-Ru Chen
With a Bachelor's degree in Pharmacy and a Master's degree in Pharmacology, I have established a robust foundation in regulatory frameworks and essential medical concepts relevant to clinical practices.
Over the course of my career, I acquired significant expertise in clinical studies. As a medical writer for a Contract Research Organization (CRO) for two years, I actively contributed to the design and execution of Bioavailability/Bioequivalence (BA/BE) studies, as well as Phase I and Phase II trials. Following this, I transitioned to the role of a primary clinical reviewer at the Center for Drug Evaluation, where I spent two years critically assessing and reviewing new drug applications. In this capacity, I gained valuable insights into the regulatory landscape, specifically in evaluating clinical trial results encompassing efficacy and safety assessments, as well as conducting thorough risk and benefit evaluations.
Additionally, I played a pivotal role in the translation of technical documents, including Informed Consent Forms (ICF), Comprehensive Study Protocols (CSP), Clinical Study Reports (CSR), and various guidelines pertinent to clinical study projects. This multifaceted experience has equipped me with a comprehensive understanding of the intricacies of drug development, regulatory compliance, and effective communication within the pharmaceutical industry
Working Experience
Senior regulatory affairs specialist • CMIC Holdings Co., Ltd.
Feb 2022 - Present
1. Wrote a customized regulatory gap analysis report on oncological drugs for NDA submission
2. Support writing a BSE report (Oncology drug) and constructing the BSE data for BSE submissions, and getting BSE conditional approval
3. Draft NDA con
3. Completed a NDA submission and get a license in HK
Primary Clinical Reviewer • Center of Drug Evaluation
2020 - 2022
1.Wrote review reports to anaylsis 5-6 NDAs (monoclonal antibody for oncology, anti-diabetic drug, anti- psychotics drug) effcacy and safety for TFDA to make a decision.
2. Wrote evulation reports for 6 post-market surveillance reports for safety issues(oncology).
3. Wrote briefing analysis for each SUSAR and analyzed the investigation drug's safety profile.
4. Wrote anaylsis reports of Risk management plans/reports and provided regulatory perspective comments to the applicants
Medical Writer • Protech Pharmaservices Corporation
2018 - 2020
1. Wrote/Designed 20 the study protocols and reports for bioequivalence studies under various countries' regulatory requirements.
2. Wrote/Designed clinical study reports for Phase I/II oncology trials
3.Prepared/Wrote essential documents for IRB and authorized agency submissions, including study synopses, informed consent forms, and response to reviewers.
4.Translated ICFs/synopsis of CSPs/CSRs for various clinical studies.
Pharmacist • Hanming Christian Hospital
2013 - 2015
1. Dispensed medications by compounding, packaging, and labeling pharmaceuticals.
2. Pharmacy service includes preparing medications, giving pharmacological information to multidisciplinary health care teams, and monitoring patient drug therapies.
3. Provided pharmacological information by answering questions and requests of health care professionals and counseling patients on drug therapy.
Master Degree. 2015 - 2017
National Cheng Kung University
Pharmacology
Bachelor's Degree. 2008 - 2013
China Medical University
Pharmacy
Publication Article
- Chen, Y. R., Li, Y. H., Hsieh, T. C., Wang, C. M., Cheng, K. C., Wang, L., Lin, T. Y., Cheung, C-H et.al., Aging-induced Akt activation involves in aging-related pathologies and Aβ-induced toxicity. (2019) Aging Cell.18, 4.
- Ji XR, Cheng KC, Chen YR, Lin TY, Cheung CHA, Wu CL, Chiang HC. Dysfunction of different cellular degradation pathways contributes to specific β-amyloid42-induced pathologies. (2017) Molecular Neurobiology
Skills
- Documentation abilities
- Pharmacokinetic knowledge
- Regulatory requirements
- Medcial Writing
- Academic English writing
- Exceptional problem solver
Certification
- English :Professional lvel
- Pharmacist of higher examination 2013/09
- Design and Interpretation of Clinical Trials 2020/06
- SDL Trados Studio for Translators_Level 1 2021/11