Diane Kalendra

About Diane Kalendra

Expertise in submission planning, medical writing, strategic document authoring, module delivery, and strategy for marketing applications (NDA, MAA) and supplements/variations. Proven matrix leadership and the ability to drive performance on global cross-functional teams including partner companies (3rd party collaborators). Manage, mentor, and oversee external and contract medical writers. Strengths include building relationships, negotiating, influencing key decision makers, adapting to rapidly changing priorities and aggressive timelines, creating risk-based strategies to enable high quality project delivery. Communicate complex technical scenarios clearly using simplified and concise messages to key stakeholders across the business.

Experience

1. Director, Medical Writing

   Immunovant

   Oct 2024 — Present

Education

• North Carolina State University

  Bachelor's Degree, Chemistry

  1999 — 2002

• The University of North Carolina at Chapel Hill

  Master's Degree, Organic Chemistry

  2002 — 2005

Skills

• Product Development
• Regulatory Submissions
• Laboratory
• Drug Development
• Dissolution Testing
• Chromatography
• Clinical Trials
• Organic Chemistry
• Dissolution
• Cmc Regulatory Affairs
• Regulatory Affairs
• High-Performance Liquid Chromatography (Hplc)
• Gmp
• Stability Studies
• Validation
• Science
• Project Management
• U.s. Food and Drug Administration (Fda)
• Pharmaceutical Industry
• Sop
• Fda
• Chemistry
• Impd
• Matrix Leadership
• Cmc
• Hplc
• Good Clinical Practice (Gcp)
• Global Drug Development
• R&D
• Standard Operating Procedure (Sop)
• Analytical Method Validation
• Regulatory Requirements
• Ind
• Analytical Methods Development
• Clinical Study Reports
• Analytical Chemistry