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Affiliate: Roche Pharma Korea
Cluster: PDG Korea
Work location: Seoul, South Korea
Your key responsibilities
Portfolio Delivery is the responsibility and accountability of all members of PDG and is necessary for the success of PDG (Roche). It encompasses how you actively partner and influence stakeholders, and foster collaborative relationships that enable us to drive impactful results. Through your commitment to streamlined processes and effective partnerships, you contribute to Roche's overall success and the advancement of patient care.
Compliance: all PDG roles are expected to know their respective compliance requirements, including training, as well as execute all work in a compliant manner
Office presence in line with local guidelines
Financial Stewardship of our spending and resources
Key accountabilities (but are not limited to)
Review and preparation of document packages for IND submission, including both protocol and CMC(IMPD summary translation)
Overall IND submissions to MFDS (new protocol with new molecule, new protocol, protocol amendment, CMC amendment)
Access internal, external communications related to clinical trial regulations.
Maintain up to date knowledge, ensure adherence and compliance with local regulatory requirements
Actively communicate with global/ government/ industry bodies to set strategy
Provide appropriate country IND submission strategies, being agile to updated guidelines.
Input into label review
Build positive networking with relevant authorities/bodies to collaborate for further enhance clinical trial process, government policies/ laws, through innovative approaches
Who you are:
You believe in the principles of Customer-Centricity, Human-Centricity, Growth Mindset, and Enterprise View.
You thrive in environments of ambiguity and collaboration where authority is distributed between all of the people involved and where advice seeking is foundational.
You apply your organizing and problem-solving skills to plan and run efficient operational and enabling aspects of Clinical Operation¡¯s programs, studies, and/or enabling projects.
You are an effective communicator that shares information transparently and strategically. You are comfortable working out loud and are an active listener.
You have established in career with at least 4 years of relevant experience and have working knowledge of Drug Development and Clinical Operations or related areas of expertise.
Minimum 1 years of experience in IND initial submission and approval will be preferred.
Submission:
English and Korean resume and self-introduction in 1 MS Word file or PDF file.
Please include your current salary and expected salary information in resume.
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Next Step:
1. Job application screening ¼·ù ÀüÇü
2. Interview ¸éÁ¢ ÀüÇü
- Interview will be informed to the candidate who passes the resume screen test.
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3. Overall assessment Á¾ÇÕ ½É»ç
4. Final notification via job offer letter ÃÖÁ¾ ÇÕ°Ý ÅëÁö
* The finalist is selected after the comprehensive assessment which includes candidates¡¯ reference check, background check on employment history, education, etc and medical check-up.
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At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we¡¯ve become one of the world¡¯s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.