This role provides Gastroenterology medical/scientific expertise in Medical Affairs and leads the overall medical strategy , including execution of tactics in alignment with respective Medical Plan for the development and/or acquisition of additional products, expansion of current indications, and pre-launch, launch and post-launch of products.
The Associate Director, MSL Therapeutic Lead and Training will lead a team of Medical Science Liaisons (MSL) in their related therapeutic area and will identify, develop and maintain all MSL training materials as they relate to company's marketed products, pipeline agents and competitors.
Work according to political, safety and quality regulations / guidelines. Contribute to and facilitate the translation of basis research results from external collaborations into more applied company research portfolio projects.
Perform activities related to QA oversight of manufacturing, packaging/labeling, inspection, QC laboratory, and plant maintenance / engineering to maintain acceptable GMP regulatory compliance and quality performance.
Responsible for an area of responsibility such as; reporting KPIs and problem solving. Process, Laboratory and Hygienic Utilities equipment root cause analysis. Reporting out the effectiveness verifications for first time occurences and also to visit recurring issues.
Building and leading a small team of idea-generators and experimentalists, charged with formulating new project proposals, and establishing the feasibility of new project ideas through design and execution of critical experiments.
Responsible for patent portfolios and their management, including: Portfolio strategy, patentability and validity assessments and drafting and worldwide patent prosecution in the areas of responsibility.
Translate assessment data into appropriate and effective education strategies and plans. Oversee the modification of content and approach based on best in class practices.
Create and execute ROI for learning programs and their effectiveness.