Lead in GQP QA operational activities for the business for company products. Ensure effective compliance, continuous improvement activities, and overall quality processes. Client Details * Global Pharmaceutical company specializing in generics, biosimiilars, APIs, and new products
Take lead in CMC RA activities for the business in regulatory strategy/maintenance to obtain and maintain regulatory approval. Contribute and support the CMC RA organization both domestically and overseas members Client Details * Global Pharmaceutical company
* Lead and project management of the following studies: - CSS (Company-led research) - IIS (Doctor-led research) - Collaborative study - Including oversight of external CRO Client Details * Leading global CRO business, with rich project
Take lead in medical writing activities in authoring clinical/regulatory documents as well as submission requirements to obtain product approval. Align with global business strategies for local requirements Client Details * One of the top global biopharmaceutical
