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Project Lead Combination Product Development
看过: 171
更新日: 07-10-2024
水平: Mid-Senior level
工作类型: Full-time
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工作内容
Our CompanyAt Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.Tasks & Responsibilities- As a Lead of a device team, you are accountable for the development of a Combination Product.
- You apply excellence in project management along the BI internal design control process to achieve development and submission in the target timeframe, in compliance with global budget requirements.
- You plan and execute drug-delivery technology development projects in cooperation with external suppliers in time and budget.
- Utilizing your expertise, you provide technical and project related presentations to internal and external project teams and steering committees.
- You are part of contract negotiations with external partners for drug delivery technologies and together with subject matter experts you manage internal and external technology developments.
- Together with subject matter experts, you ensure the compliance to internal and external regulations (US, EU) for drug delivery devices/combination products. You support and represent drug-delivery technology strategies in meetings with regulatory authorities when required.
- If necessary, you author, contribute, review and approve relevant design control, risk management and usability engineering documentation.
- You contribute with your experience to further improve and strengthen all structures and processes underlying a state-of-the-art drug delivery technology development, manufacturing and life-cycle management.
- You are part of an agile team, always striving for excellence in project management and combination product development.
- You provide scientifically sound and compliant proposals, concepts and results for the integration of combination product development in the overall project strategy, with the aim of a successful submission and approval of the Combination product.
- You provide strategic concepts for Combination Product and device platform development to decision making committees.
- Master´s degree or PhD in Life Science, Pharmacy or Engineering
- Comprehensive knowledge of internal quality procedures in pharma industry
- Sound knowledge of Medical Device, Combination Product regulatory or development function
- Strong project management skills for pharmaceutical development programs with a focus on Combination Products incl. management of complex teams and topics
- Highly self-organized, solution oriented and proactively communication skills with a strong decision- making mentality
- Fluent in English (both written and spoken)
- Proven experience in Medical Device or Combination Product regulatory or development function
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最后期限: 21-11-2024
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