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Novartis
last mo.

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

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

Description

As a Senior Expert - Device Project Leader, you will guide cross-functional teams in managing the drug-device combination product portfolio, ensuring compliance and supporting regulatory processes while driving project success.

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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

Education

Master's degree
OR
Doctoral / PhD

Work Experience

2 - 4 years

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

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
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