Senior Strategic Technical Leader

1 mese fa

Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno
Job Summary

We are seeking a highly experienced Senior Strategic Technical Leader to join our Global Product Team at Chiesi Group. As a key member of our team, you will be responsible for representing the Product(s) Technical/GTD expertise and acting as the single project representative within your function.

Main Responsibilities
  • Contribute to shaping and optimizing the Global project strategy in collaboration with GPL, DL, and the rest of the Core Team, acting as SME for the reference functional area.
  • Act as the single Functional Area voice and reference within the Core Team and the single project representative within your function.
  • Ensure GTD strategy definition with proper alignment and integration of pharmaceutical development and R&D development plan.
  • Act as champion and advocate of the project within your function.
  • Guarantee proper and full understanding of Functional area related activities to fulfill the Project needs.
  • Foresee, anticipate, and highlight risks/criticalities/impact on other functions following your function's proposals/results.
  • Actively contribute to cross-functional project decisions with all CTMs.
  • Build and lead the (cross or extended) team with the right competences to deliver the functional plan and/or work packages supporting the product(s) strategy agreed with the project team.
  • Ensure leadership of Extended Technical team for the assigned project(s).
  • Help all GTD services/disciplines to understand projects plans and related strategies, to guarantee proper and full understanding of development and GTD related activities to fulfill the needs.
Experience Required

At least 8 years in R&D GTD of a pharma company and/or CRO/CDMO. Highly experienced in leading and managing internal and external activities and stakeholders, experience from regulatory interactions with EMA and FDA, as well as other regulatory authorities.

Education

Scientific Master Degree.

Languages

English fluent.

Technical Skills
  • Robust knowledge of pharmaceutical product development process.
  • Knowledge of ICH/GMP requirements.
  • Knowledge of principles, approaches, and planning tools.
  • In-depth understanding of the regulatory requirements for product development and industry standard.
  • Direct experience from regulatory interactions related to CMC preferably with EMA and FDA.
  • Proven experience with CMOs and CROs.
  • Good knowledge regarding GMP compliance.
  • Awareness of sustainability impact of development activities.
Soft Skills
  • Communication skills.
  • Leadership and social influence.
  • Strategic thinking.
  • Planning and organizational skills.

We offer a dynamic, fast-growing, challenging, and friendly environment. We invest in continuous training, learning, and development. We strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being. We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues, and many other people-care services.

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