Associate, Regulatory Business Capabilities

Location: Shanghai, China

Company

hirify.global is a pharmaceutical and healthcare company operating with international teams and regulated information systems.

What you will do

• Investigate operational issues and develop written materials communicating solutions and options to stakeholders.
• Execute and coordinate user acceptance testing for system releases and information solutions before deployment.
• Manage critical information and records in GRS-owned repositories in accordance with external regulations, internal processes, and retention schedules.
• Gather usage and support metrics and generate standard reports for GRS systems.
• Update master data and standard configuration data in accordance with standard operating procedures.
• Participate in system release activities and collaborate with international and cross-functional teams.

Requirements

• Bachelor's degree or equivalent work experience.
• Basic knowledge of healthcare and/or pharmaceutical drug development environments and regulations.
• Customer relationship skills, team collaboration, and the ability to work in a cross-functional environment.
• Strong verbal, written communication, and presentation skills.
• Ability to interact professionally and build collaborative relationships with internal hirify.global teams.
• Ability to work with international colleagues and understand the potential impact of system and process changes on sites and affiliates outside the home country or region.
• Strong project management and organizational skills.
• Training or equivalent experience in current information management concepts and practices.
• Knowledge of application system management and change control processes, application validation, and implementation in a GxP environment.
• Knowledge of healthcare and/or pharmaceutical metadata and standards.

Nice to have

• Experience with query tools and data extraction techniques such as SQL, PL/SQL, Brio, or MS Access.

Culture & Benefits

• Full-time employment.
• Collaboration with international colleagues and internal hirify.global teams.
• Work in a regulated healthcare and pharmaceutical environment.