Clinical DD&BD Manager, Raniganj
Clinical DD&BD Manager, Raniganj
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Raniganj, India
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Posted: less than a week ago
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Description
Your Key Responsibilities Your responsibilities include, but not limited to: Evaluate appropriateness of clinical development programs or dossiers offered by partner companies (due diligence = DD): evaluate and review available clinical data (including bioanalytical data, in-vitro studies and dissolution data), prepare dossier assessment summaries for BD and regulatory team including project related risks and proposed risk mitigation strategiesProvide scientific and regulatory advice to BD and partner companies as needed to correct the gaps or minimize the risks identified Provide inputs to BD with budget planning and contract negotiations for in-licensing deals Collaborate and interface with BD and regulatory teams to support responses on deficiency letters during regulatory proceduresDevelop clinical strategies for countries in scope and keep overview of ongoing and planned clinical activities Support local clinical teams with scientific inputs and guidance for execution of clinical studies for BD products Collaboration with wider clinical development community. Collaboration on global clinical initiatives. Responsibility for personal and professional developmentOther tasks determined during the annual objectives setting process and by KPIs. Other tasks as assigned by the supervisor, and tasks based on a specific appointment Essential Requirements What you'll bring to the role: Qualification: University degree (BSc) in pharmacy, medicine or other related natural scienceLanguages: Fluent in English; Knowledge of Microsoft Office Work Experience: 3 years of experience in clinical development or associated fields Language English.
Highlights
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Company namesandoz india
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Job positionClinical DD&BD Manager
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