Leads risk alignment committee meetings (departmental multidisciplinary team), facilitates therapeutic team participation as appropriate, facilitates informed decision-making and dissemination of scientifically balanced and quality risk information regarding products.
June 04, 2022
Provide scientific input into project regulatory strategy(ies) by ensuring robust assessment of scientific content and critical evaluation of supporting regulatory documentation to confirm acceptability and identification of potential risks.
January 23, 2023
Participates in the development of other technical contributors by facilitating training and providing feedback and guidance.
March 15, 2023
Develop standard operating procedures, evaluate emerging regulations and changing regulatory landscape for impacts, provide strategic advice, and communicate with stakeholders which may include recommending applicable education and training to personnel for assurance of regulatory compliance.
April 17, 2023
Assists in the preparation of document output that meets requirements for publishing documents that interact appropriately with sponsor and/or regulatory agency software systems/program The Contractor shall ensure that all final electronic deliverables meet current regulatory electronic document requirements and guidance.
April 22, 2023