한국로슈 Clinical Operations Lead 정규직 채용

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.