Description

The Product Manager (Business Development)'s primary responsibility is to bring projects sourced with external partners by Business Development onboard into Clinigen's Japan business. The incumbent has a background in launching pharmaceutical or medical device products, with some experience in supply chain planning and/or quality and/or regulatory affairs.

Key Accountabilities:

• Project and Process Management
• Partner Management
• Product Management
• Data Analytics and Reporting
• Knowledge and Compliance
• Administration

Major Tasks & Activities:

• Work with Business Development and internal/external partners to plan and deliver the due diligence (ensuring risk/benefit analysis) of projects for bringing new products or services to the Japan business.
• Work with key internal and external stakeholders to bring projects from green light through launch into the Japan market.
• Continually monitor processes through a feedback loop such as PDCA to enable organizational learning
• Act as the key counterpart for the project manager or equivalent in the partner company, including managing communications.
• Manage and track working group meetings and subsequent actions to enable realization of the launch and the future growth strategy of the project
• Facilitate meetings and keep meeting records
• Maintain, update and report the project risk register
• Exhibit a proactive and collaborative approach in coordinating with other internal functions as required to ensure timely resolution of supply issues
• Ensure all activities are carried out according to GDP, GMP, or other relevant industry, regulatory and ethical standards, including through agreement and management of SOPs, SLAs or KPIs internally and with external vendors or CMOs
• Manage the due diligence and onboarding task force that usually comprises Regulatory Affairs, Quality Assurance and Pharmacovigilance IT Data Migration.
• Attend and run project meetings as applicable.
• Support Business Development (where applicable) with partner company business plan development
• Ensure internal reporting and regulatory filing and documentation are completed on time and within budget and compliant with standard processes and formats.
• Liaise with Business Development to ensure projects are conducted efficiently
• Maintain a current and comprehensive knowledge of the regulatory environment, including specific regulations and associated guidelines, apply this knowledge in day-to-day activities.
• Maintain a current and comprehensive knowledge of Clinigen and its standard operating procedures and best practices
• Maintain a current and comprehensive knowledge of the external environment that affects Clinigen's business, particularly competitors and the local healthcare environment

Requirements

MUST HAVE/BE:

• Project management experience in the pharmaceutical or medical device industry - especially in the areas of supply chain planning and/or quality and/or regulatory affairs
• Data-driven and analytical, with a logical approach to planning to identify and mitigate risks, and leverage opportunities
• Highly articulate, with excellent verbal and written communication skills and strong presenting ability
• Proactive and solutions-driven, with a high level of accountability and ownership for driving results; entrepreneurial mindset
• Ability to build strong working relationships with internal and external stakeholders to collaborate effectively on projects with mutually beneficial outcomes
• Ability to create, coordinate, and maintain integrated plans and control or respond to changes in strategy and scope
• Ability to work collaboratively as a team member across various functions
• Ability to prioritize and work independently in an ambiguous, constantly changing environment
• Ability to read, write and actively participate in meetings in English and Japanese

NICE TO HAVE/BE:

• Adept in working group management, task management, and risk tracking
• Ability to manage up, down and across, track performance against objectives, use meeting management tools and techniques, make decisions, and resolve conflict

Benefits

• Competitive base salary
• Annual performance bonus
• Ongoing professional development
• Flexible working arrangements
• Supportive team environment