Job Description

Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.

We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC and South Africa. Clinigen has grown rapidly since we began, we are the leader in Managed Access programs and positioned well for an exciting future of continued expansion.

To support our growth, we are seeking a motivated and results-driven Business Development Manager to join our dynamic team. In this role, you will be responsible for driving new business development opportunities and managing client relationships to promote our range of services.

This is an exciting opportunity for someone looking to contribute to a leading business in the pharmaceutical and life sciences sector, with the potential for longer-term career advancement.

The Business Development Manager provides analytical support to the BD Head for lead identification, business case preparation, and project negotiation with external partners. After deal signing, the BD manager will oversee the onboarding of new products into Clinigen's Japan business. A background in project management for pharmaceutical or medical device launches, along with experience in supply chain planning and/or quality and/or regulatory affairs, is required.

Key Responsibilities:

• Work with Business Development and internal/external partners to identify potential leads, 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 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

• 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
• Ability to smoothly work through internal debates and resolve differences of opinion, identifying the best way forwards for the business

This is a fantastic opportunity to join Clinigen, a leader in pharmaceutical services, and play an essential role in driving our business forward. We are looking for individuals who are passionate about making a difference and eager to advance within a thriving organization.

Interested? We would love to hear from you, please apply today for consideration.

Benefits

• Competitive base salary
• Annual Performance Bonus
• Annual Remuneration Review
• Ongoing professional development
• Supportive team environment

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