Regulatory Submission Associate III - Remote (Part-Time)
(e.g., IND, NDA, MAA, NDS, CTA, DSUR, PSUR, REMS, etc.). Excellent verbal and written communication and presentation...
(e.g., IND, NDA, MAA, NDS, CTA, DSUR, PSUR, REMS, etc.). Excellent verbal and written communication and presentation...
activities related to the practice of pharmacy in accordance with state and federal laws and REMS programs Maintains a safe...
limited distribution agreements, payer contracts, and REMS programs as required. 5. Assist with expanding scope...
o Copay Assistance o Free dispense o Rems data (Good to Have) * Data sources o Veeva Data (CRM, Network, Alignment...
to minimize issues. Conduct follow-up and counseling as required by regulatory agencies such as REMS. Stay updated on pharmacy...
, DUS, effectiveness of REMS and RMMs) in support of clinical development, regulatory filings, and post-marketing...
and coordination with other departments and staff Compliance to all REMS program requirements, as applicable. Compliance...
to all REMS program requirements, as applicable. Compliance to and education for all accreditation programs including VAWD, ACHC...
Assistance o Free dispense o Rems data (Good to Have) * Data sources o Veeva Data (CRM, Network, Alignment) o Specialty...
., PASS, PAES, PMR, DUS, effectiveness of REMS and RMMs) in support of clinical development, regulatory filings, and post...