Utilize scientific concepts and broad technical expertise in a wide variety of methods, techniques and procedures.
Review and evaluate manufacturers and sponsors data and results, method of synthesis and proposed manufacturing and testing procedures.
Request and evaluate analytical method validations and determines methods suitability for regulatory purposes
Evaluate scientific submissions which pertain to chemistry, manufacturing processes, controls, stability, technical aspects of labeling and other related scientific specialty area related to hemostasis products.
Develop policy and determines approvability of applications related to all aspects of manufacturing and controls, testing formulation and specifications for blood coagulation products.
Resolve scientific and technical complex problems surrounding the products reviewed.
Prepare written correspondence to outside organizations requesting additional information used to make regulatory determinations.
Write guidance documents and standard operating procedures on review and regulatory processes.
Prepare memorandums and reports summarizing analysis results and inspectional activities and observations.
Prepare and present formal/informal remarks at briefings, training sessions, consumer industry workshops.
Act as agency liaison to industry committees and organizes public workshops.
Provide consulting functions of technical and regulatory nature to various agency offices.
Train and mentor other staff on scientific and regulatory matters. Bottom of Form