MaryClare DeLuca

Served as Global Medical Writing Lead for antifungal compounds across all development stages.

Managed creation of specialized documents, including CTD marketing applications and clinical study reports.

Ensured compliance with ICH and local regulatory requirements and internal style guidelines.

Reviewed documents for message consistency and alignment with project strategy.

Led cross-functional initiatives to enhance standards, productivity, and processes.

Served as Global Medical Writing Lead for a variety compounds across all development stages.

Managed creation of specialized documents including CTD marketing applications, INDs, NDAs, and clinical study reports.

Ensured compliance with ICH and local regulatory requirements through thorough document reviews.

Led initiatives to enhance cross-functional standards and productivity in medical writing processes.

Achieved first cycle approval for in-licensed antifungal drug through successful US and EU submissions.

Participated in FDA Advisory Committee meeting, leading briefing document preparation and war room support.

Oversaw document creation in Senior Manager role, ensuring adherence to ICH/FDA standards.

Coordinated consultants for project assignments while providing guidance to four direct reports.

Maintained multiple INDs and NDAs for dermatology, functional dyspepsia, and transplant medications.

Facilitated creation of INDs and NDAs through internal meetings and FDA communications.

Generated daily updates on FDA information by monitoring key websites and industry newsletters.

Reviewed promotional labeling and advertising materials for compliance with FDA regulations.

Evaluated protocols, clinical study reports, and data to ensure accurate product representation.

Advised teams on regulatory requirements impacting R&D programs and future filings.

Researched FDA CFRs and guidelines to aid decision-making in regulatory gray areas.

Represented Astellas at agency meetings to advocate for product interests.

Maintained multiple INDs and NDAs for anti-infectives, anti-virals, and metabolics.

Facilitated creation of INDs and NDAs through internal meetings and FDA communications.

Reviewed protocols, clinical study reports, and data to ensure accurate product representation.

Submitted IND safety reports and post-marketing safety reports in compliance with regulations.

Prepared and updated global regulatory strategic documents for effective submissions.

Advised teams on regulatory requirements impacting R&D programs and product labeling.

Researched FDA CFRs and guidance to clarify ambiguous regulatory decisions.

Represented Abbott in agency meetings to foster collaboration and compliance.