Associate Director, Precision Medicine Digital Health

The Associate Director, Precision Medicine Digital Health leads global regulatory strategies to support the development and approval of biomarkers, companion diagnostic tests, digital health solutions, and other devices associated with pharmaceutical products across therapeutic areas.

Requirements

• Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas.
• Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies.
• Co-lead marketing application submission teams for indications that are at regulatory filing stage to develop content strategy for global dossiers.
• Ensure consistent positions are presented in responses to global Health Authority (HA) queries.
• Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input.
• Provide input into the development of protocol synopses and protocols.
• Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.
• Contribute in the developing of target labeling.

Benefits

• Competitive benefits, services and programs
• Flexible work environment
• Opportunities to pursue goals, both at work and in personal lives