Experience with various document types (CSR, CMC, Nonclinical, CRF) and applications (IND, NDA, ANDA)
Some global application experience (US, EU, etc.)
Expert in publishing, submission tasks.
Good knowledge on FDA, GCPs, ICH guidelines, Life Sciences and Pharmaceutical Industry.

Performs document publishing tasks for authorization of applications, notices and electronic submission forms required by Food and Drug Administration and International Standards Organization regulations.
Experience working on health authority procedures / guidance regarding electronic submissions

Applies knowledge of company and client regulatory publishing process, standard operating procedures, updates to regulatory authority guidelines, and software updates to ensure submission currency and compliance.
Communicates and coordinates effectively with project team members. Ensures timely resolution of publishing issues.
Provides quality and timely deliverables to meet the client s expectation.
May participate in client meetings and lessons learned sessions to address publishing related matters.