Summary

Location: Basel, Switzerland,
Type: Hybrid Working #LI-Hybrid, Temporary for two years

With the increasing diversity of Novartis' portfolio, the need for drug-device combination product documentation packages is increasing. As such, we are searching for an Associate Director with combination product development experience to lead the creation of strong documentation-packages.

Job Description
As a member of the device sub team for your project(s) you will be the main contact & coordinator for all project-specific documentation tasks related to data driven, innovative documentation approaches with a focus on challenging projects and platforms.

About the Role

Your responsibilities include but are not limited to:

• Leading documentation strategies for highly complex, pioneering Drug-Device combination products including pilot documents fulfilling the current Health Authority (FDA, EMA) expectations.
• Leading data driven improvements enabling the conversion of regulatory expectations to solid source documentation using existing systems such as Polarion
• Building the link between technical development and Regulatory Affairs to enhance the mutual understanding
• Leading timely evaluation and implementation of design changes
• Contributing to technical development and regulatory relevant decisions
• Authoring pilot documents that fulfil the current Health Authority expectations
• Leading x-functional overarching initiatives; mentoring (senior) experts
• Contributing to and reviewing regulatory documents, supporting product registrations, presenting to Health Authorities.

• Master or PhD in engineering or functional/chemical/bio analytics or equivalent and minimum 20 years' experience in pharmaceutical industry, including drug-device combination product development
• Demonstrated experience of technical development of medical devices/device constituent parts of combination products (e.g. autoinjectors)
• Demonstrated experience of current Health Authority expectations for combination products (contributing to and reviewing of submission relevant documentation)
• Strong knowledge of and working experience with EU Medical Device Regulations, ISO 13485 and US regulations 21 CFR Part 4 and 21 CFR Part 820
• Strong experience and interest in driving improvements of development/documentation approaches and/or Quality Mgmt System (e.g. design control)
• Leading and influencing in global matrix organization; strong communicator & listener, actively reaching out, able to understand and connect across functions
• Collaborative spirit, self-driven attitude, high level of learning agility • Fluent in English (oral and writing)