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Senior Expert - Device Project Leader - Combination Product Portfolio 3(m/w/x)

Schaftenau
from 65,605.54 / year
Full-timeWith Home OfficeSenior
Apply now

Representing GDPD in CMC sub-teams, managing device and packaging issues for drug-device combination products in the pharmaceutical sector. Master/PhD in science/engineering, with regulatory guidelines for drug-device combination products essential. Childcare facilities available.

Requirements

  • Master or PhD in natural science, engineering, pharmaceutical field, or equivalent
  • Minimum 2-4 years of experience in the pharmaceutical industry, preferably in drug-device combination product technical development
  • Ability to work and lead a cross-functional team in a matrix environment
  • Proven knowledge and track record in project and program planning and execution
  • Understanding and awareness of regulatory guidelines for drug-device combination products, including relevant ISOs and cGMP
  • Collaborative spirit, self-driven attitude, high level of learning agility, good listening skills, strategic thinker
  • Fluency in English (oral and writing), German is beneficial

Tasks

  • Represent GDPD in CMC sub-teams
  • Lead device-related discussions and secure project strategy endorsements
  • Act as the single point of contact for device and packaging issues
  • Plan and manage project resources, schedules, and budgets
  • Assess and negotiate internal and external resource needs
  • Establish and maintain a high-quality Design History File
  • Ensure compliance with internal processes and regulations
  • Contribute to process and delivery technology improvements
  • Evaluate device technology for different project phases
  • Support internal and external audits on packaging and medical devices
  • Assist in preparing regulatory dossiers for medical device registration
  • Respond to health authority queries

Work Experience

  • 2 - 4 years

Education

  • Master's degree

Languages

  • English – Business Fluent
  • German – Basic

Benefits

Competitive Pay

  • Market-competitive base salary

Bonuses & Incentives

  • Attractive incentive program

Retirement Plans

  • Modern company pension scheme

Childcare

  • Childcare facilities

Learning & Development

  • Learning and development opportunities

Career Advancement

  • Worldwide career possibilities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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