RA Specialist at Top Global CRO Start-up

Be part of a top 10 Global CRO that's entering the Japan market as a first member. Lead in RA activities to submit clinical trial documents to obtain approval.

Client Details

• Top 10 global CRO specializing in phase II-III clinical trials for oncology, infectious diseases, IBD, hematology, rare diseases, etc.
• Global footprint in 60 countries around the globe
• International working environment with lean organisational structure
• Partnering with some of the top pharmaceutical clients in the industry
• Looking to enter the Japan market as a focus

Description

• Develop key RA development strategies for clinical trials/studies locally
• Evaluate study feasibility from a regulatory/business point of view
• Prepare clinical trial submissions to local health authorities
• Communicate with health authorities (PMDA), external stakeholders, etc. on regulatory processes
• Review translational materials and documents in regards to clinical trial submissions
• Track regulatory submission activity time lines
• Manage any changes, amendments, etc. on clinical research
• Deliver any necessary training from a regulatory point of view

Job Offer

• Competitive salaries and benefits
• Great work life balance
• International working environment
• Be one of the first member for the business in Japan
• Amazing career progression
• Work with industry leaders who are solving various unmet medical needs

Page Group Japan is acting as an Employment Agency in relation to this vacancy.

• University degree in scientific or related field
• Extensive RA submission for clinical trials experience to local health authorities
• Knowledge of local regulations for clinical research
• High fluency in English and Japanese (non-native level speakers will not be selected)
• Leadership and people management capability