Regulatory Affairs Specialist - Seoul - ICON Clinical Research와 관련된 현재 작업
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Regulatory Affairs Associate
3 개월전에
Seoul, 대한민국 Novo Nordisk 풀타임Are you passionate about ensuring regulatory compliance for new products and product amendments? Do you thrive in a fast-paced environment and enjoy working with key stakeholders to navigate regulatory frameworks? If so, we have an exciting opportunity for you to join our team as a Regulatory Affairs Associate at Novo Nordisk Korea. Apply today for a...
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Senior Specialist, Quality
5 개월전에
Seoul, 대한민국 Cardinal Health 풀타임The Company and Business Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a global, integrated healthcare services and products company, providing customized solutions for hospitals, health systems, pharmacies, ambulatory surgery centers, clinical laboratories, and physician offices worldwide. The company provides clinically proven...
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Seoul, 대한민국 Merck KGaA, Darmstadt, Germany 풀타임We are seeking a Regulatory Management Specialist responsible for supporting our export and import regulatory & compliance matters from a pharmaceutical/in-vitro diagnostic perspective.This position will collaborate with Global Regulatory and management stakeholders on various international regulatory compliance projects. The role will support our Life...
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RA Specialist
5 개월전에
Seoul, 대한민국 Ortho Clinical Diagnostics 풀타임The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing...
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P&R Specialist
5 개월전에
Seoul, 대한민국 AstraZeneca 풀타임Role description - Develops and implements pricing and reimbursement strategies for new products reimbursement/ reimbursement scope expansion to secure accelerated market access with optimal pricing - To minimize price erosion or access restriction due to various cost containment measures by the government. Typical Accountabilities - P&R dossier...
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P&R specialist
5 개월전에
Seoul, 대한민국 AstraZeneca 풀타임Role description - Develops and implements pricing and reimbursement strategies for new products reimbursement/ reimbursement scope expansion to secure accelerated market access with optimal pricing - To minimize price erosion or access restriction due to various cost containment measures by the government. Typical Accountabilities - P&R dossier...
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Regional Medical Advisor
1개월전에
Seoul, 대한민국 Novo Nordisk 풀타임Are you passionate about scientific and medical knowledge? Do you thrive in building relationships with key opinion leaders and healthcare professionals? We are looking for a Regional Medical Advisor (1 year contract) to join our team in the Clinical, Medical, Regulatory (CMR) department in Korea. If you are ready to make a difference in the field of...
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Regional Medical Advisor
4 개월전에
Seoul, 대한민국 Novo Nordisk 풀타임Are you passionate about scientific and medical knowledge? Do you thrive in building relationships with key opinion leaders and healthcare professionals? We are looking for a Regional Medical Advisor (1 year contract) to join our team in the Clinical, Medical, Regulatory (CMR) department in Korea. If you are ready to make a difference in the field of...
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Seoul, 대한민국 Novo Nordisk 풀타임Are you passionate about scientific and medical knowledge? Do you thrive in building relationships with key opinion leaders and healthcare professionals? We are looking for a Regional Medical Advisor (1 year contract) to join our team in the Clinical, Medical, Regulatory (CMR) department in Korea. If you are ready to make a difference in the field of...
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Seoul, 대한민국 AstraZeneca 풀타임Job Responsibilities Medical expert on clinical development and local commercialization decision - Be in charge of newly introducing disease area (across CVRM/R&I/V&I/Rare disease/Oncology) which AZ Korea medical affairs do not yet have coverage of the disease area. - Continuously acquire and update necessary scientific knowledge on new therapeutic...
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Seoul, 대한민국 Novo Nordisk 풀타임Are you passionate about driving strategic initiatives and programs in the field of Real World Evidence (RWE)? If so, we have an exciting opportunity for you to join our Clinical, Medical, Regulatory Affairs (CMR) department as a Real World Evidence Associate. Read on to learn more and apply today for a life-changing career. About the departmentThe...
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Seoul, 대한민국 Novo Nordisk 풀타임Are you passionate about driving strategic initiatives and programs in the field of Real World Evidence (RWE)? If so, we have an exciting opportunity for you to join our Clinical, Medical, Regulatory Affairs (CMR) department as a Real World Evidence Associate. Read on to learn more and apply today for a life-changing career. About the departmentThe...
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Seoul, 대한민국 Novo Nordisk 풀타임Would you enjoy helping to move the pharmaceutical industry forward by facilitating the communication of scientific data and the sharing of knowledge among medical experts all over the world? Does interacting with leading Global Medical Doctors and Scientists on new innovative portfolio interest you? If yes, join us on an exciting journey as a Medical...
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Sr QA Specialist, APAC
5 개월전에
Seoul, 대한민국 Boston Scientific 풀타임Additional Locations: N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the...
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Seoul, 대한민국 Kuehne+Nagel 풀타임JOB DESCRIPTION You will be joining our Operational Care Team to add your expertise + skills to the delivery of Operational Excellence. Your Role You will be enabling transport activities by executing bookings, entering orders + generating all required export documentation while liaising with our Customer Care Specialists to ensure all requirements are...
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Seoul, 대한민국 Albemarle 풀타임Description Reporting to the APAC Global Trade Compliance Manager, the Trade Compliance Specialist will manage the compliance activities and efforts in Korea to ensure adherence with import/export laws, improve operational efficiency, develop KPI’s, as well as partner with other Global Trade Compliance Specialists to implement Albemarle’s trade...
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Real World Evidence Manager
5 개월전에
Seoul, 대한민국 Novo Nordisk 풀타임Are you passionate about driving strategic initiatives and programs in the field of Real World Evidence (RWE)? Do you have experience in managing teams and engaging with stakeholders? If so, we have an exciting opportunity for you to join our Clinical, Medical, Regulatory Affairs (CMR) department as a Real World Evidence Manager. Read on to learn more and...
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Seoul, 대한민국 Novo Nordisk 풀타임Are you passionate about driving strategic initiatives and programs in the field of Real World Evidence (RWE)? Do you have experience in managing teams and engaging with stakeholders? If so, we have an exciting opportunity for you to join our Clinical, Medical, Regulatory Affairs (CMR) department as a Real World Evidence Manager. Read on to learn more and...
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Seoul, 대한민국 CSL 풀타임Position Purpose: MSL the Medical Team in providing strategic medical input into all relevant areas at CSL including Medical Affairs, Clinical Research, Regulatory Affairs, Pharmacovigilance, Quality, Sales and Marketing, Public Affairs and Market Access. As a field-based medical expert, the MSL supports CSL Behring’s products and therapeutic areas by...
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(Sr.) Supply Chain Manager
2 개월전에
Seoul, 대한민국 Novo Nordisk 풀타임Are you an experienced Supply Chain professional with a passion for driving operational excellence? Do you thrive in a fast-paced and dynamic environment? We are looking for a Supply Chain Manager to join our team at Novo Nordisk. If you are ready for a new challenge and want to make a difference in the healthcare industry, read on and apply today for a...
Regulatory Affairs Specialist
3 개월전에
At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.
Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.
Regulatory Affairs Specialist
Seoul, Korea
Job Description:
・Participate in regulatory and/or clinical trial project teams as required
・Plan and track designated project activities including financial tracking under supervision
・Initiate research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements
・Effectively contribute to all the aspects of allocated projects in timely manner including tracking (time and resources) , proactive identification of risks, scope change, financial implications and provision of solutions for approval by Managers/Directors
・Be able to solve the problems in pro-active and timely manner by identifying the deficiencies in the existing processes and procedures and providing the possible solutions
・Work closely with Process/Project Management team to identify process and procedure improvements and assist in implementation of continuous improvement measures to ensure department expertise and to meet department goals
・Specific Regulatory Submission team activities include (but are not limited to)
・Input into Preparation, compilation and submission of CT /IND, MAA I NOA, Variations/ lifecycle submissions, DSUR, PSUR, renewals, agency briefing documentation, medical device documentation, Readability testing
・Input into label review, translation requirements, fee requirements, etc.
・Input to the Regulatory Intelligence function
・IMPD I IB Core Doc review, labeling review for clinical trial applications
・Communicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required.
・Peer review, QA and/or checking, as appropriate, of documents prepared by other professionals within GRA/ICON
・Identify issues and address them in a timely manner, including preventive actions. Be solution orientated and own the delivery and commitment on behalf of ICON
・Responsible for timely and accurate completion of assigned projects and for timely identification of issues or the need for change orders
・Be able to liaise and advise clients on the process and timelines, changes to the regulations as required ensuring timely and quality delivery of projects
・Develop and maintain a current awareness of regulatory requirements through publications, seminars and appropriate training courses as deemed necessary
・Maintain an accurate record of the time associated with each activity
・Travel (approximately 10%) domestic and/or international
Qualification s :
・ Bachelor's Degree or higher graduate degree from the Medical/science background and/or discipline
・ At least 2+ years of professional experience for preparation of submission package and regulatory submissions for IND approval with full understanding of IND submission requirements and activities
・Experience in communicating with MFDS as the main contact for initial IND, IND amend and notification preferred but not a must
・Experience in developing Country Informed Consent Forms and following up with Legal as needed in accordance with the protocol.
・Knowledge of local regulatory requirements/guidelines and global standards, mainly for IND application
・Good interpersonal communication skills
・ Excellent written and spoken English and fluency in Korean
・Competent computer skills
Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours. But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
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