Arijeet Dutta

Work Experience

- Compilation, publishing, and technical troubleshooting for US market (BIOLOGICS) using eCTDxpress and Docubridge tool.

- Assignment of task among the team and guide them for better planning.

- Trained the junior associate for publishing activities.

- Working as a Qcer for checking quality of publishing output before dispatch.

- Co-ordination & Publishing of Advertising & Promotional Submissions end to end ( Form creation ) And IND Serious Adverse Event(SAE) submissions.

- Compilation, Validation and Submission of eCTD for IND, NDA, BLA for US Market.

- Bookmarking, hyper-linking and other PDF properties per Health Authority (HA) guidelines.

- Technical quality control of published output before release to the HAs.

- Working on major biological submissions as Initial submissions and also worked on Dataset submissions.

-Well Versed with the Dispatch Activity through different types of dispatch format like Gateway & Email to US MARKET.

- Working on US submissions ( biologics) as a Publishing Associate.

- Publishing, technical troubleshooting for US market using eCTDxpress and Docubridge tool.

- Bookmarking, Hyperlink and other PDF properties as per Health Authority.

- Working on Complex submissions like CSR, Annual Report etc

- Working as IND SAE coordinator.