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Technical Expert
2 weeks ago
About Our Client
a United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries.
Through its innovative business model, it partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations.
Job DescriptionIn Licensing
:
Provide technical insights to the scientific team for identifying and prioritizing candidates for in-licensing.
Participate in feasibility studies and provide technical assessments of the products considered for in-licensing:
evaluation of manufacturing capacity, good manufacturing practices, regulatory steps etc.
Assist the patent team in evaluating the patent landscape of the candidates for in licensing.
Provide technical insights to license negotiations and agreement finalizations.
Out Licensing
:
Assist the team in the Expression of Interest process for selecting generic manufacturers.
Proactively engage with sublicensees to identify areas of concern and development bottlenecks; provide technical support and suggest solutions to accelerate development and marketing of the product.
Alliance Management and Other Activities:
Track development activities and regulatory filing processes and monitor compliance with the license agreement.
Work closely with the Alliance Management team to ensure effective management of relationships with both sublicensees and originator companies.
Attend quarterly review meetings (QRMs) and collaborate cross-functionally where technical insight is required to support the mission.
Perform other duties as assigned by the by the Head of Business Development and Head of Alliance Management
The Successful Applicant
EssentialA University degree life sciences, Pharmacy, or other relevant discipline, with a strong scientific/technical background.
Approximately 15 years of experience in the pharmaceutical industry, specifically in product development.
A deep understanding of the generic drug development process and regulatory requirementsExcellent project management skills, with the ability to manage multiple projects / accounts at the same time.
Native proficiency in written and spoken English.DesirableKnowledge of different product categories and dosage forms, including small molecules and biologics.
Proficiency in additional areas of product development such as regulatory affairs, patents, manufacturing, and quality assurance.
Ability to apply industry knowledge to the projects, with a strong inclination towards learning and innovation in diverse areas related to pharmaceuticals, public health, and voluntary licensing.
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