Provide medical, legal, and verbatim transcription services; provide editing and archiving services.

-Act as regulatory point for AdPromo PRC/MLR process, liaising with OPDP as needed. Led team through 3 label updates including removal of boxed warning and launch of a new indication.-Provide review of material and strategic regulatory advice to cross matrix team-Actively participate in the creation and maintenance of global regulatory documents including ex-US regulatory filings (specifically labeling components); acted as lead labeling point during EMA filing and approval-Participate in the review of abstracts, manuscripts, and posters for medical publication -Provide regulatory review of Medical Affairs materials including slide decks and medical response letters-Act as lead for PRC processes and systems; updated PRC Process (including creation of SOP and several Jobaids) and Veeva PromoMats system

-Acted as lead AdPromo reviewer for several launches including in: 3 in different lines and types of lung cancer, mesothelioma, juvenile idopathic arthiritis.-Provided review of material and strategic regulatory advice to cross matrix team-Acted as lead for multi-channel communications hub, working to create standards for promotional material, and channels, across the company

Collaborate with commercial/marketing, legal, and medical to provide regulatory advice on promotional material for two oncology products to ensure consistency with applicable FDA regulations and guidances, internal policies, PhRMA guidelines, and FTC guidelines-Review advertising/promotional materials for several marketed products (including oncology, immunology and now immuno-oncology), as well as press, educational, and training materials-Provide training on FDA regulations for advertising and promotion to internal and external agents- 4+ years experience with Subpart H product/submissions

Provided the review and approval for promotional labeling docuements for active and mature brands ensuring alignment with PLR format and labeling regulations.

I crochet and knit for a hobby. I've started selling the items that I have completed.

Scius, LLC (formerly DiMedix) is a CME company. Position was a Senior Project Coordinator where I worked with HCPs to create and present enduring materials as well as live symposia.

Phoenix Marketing Solutions is a medical marketing company owned by Phoenix Group Holdings. Phoenix Group also owns DiMedix (a medical education/CME company), and Augenix (an audience generation company).My role as Scientific Resource Associate is in the Scientific/Editorial Department. I support the department by ordering and keeping references and permissions, doing necessary research, putting together reference binders, processing invoices, acquiring temporary help for the department, and copyediting documents.