Nilima Jaiswal

About Nilima Jaiswal

Experienced Medical Writing Document Specialist & Regulatory Affairs Submission Publisher with a demonstrated history of working in the pharmaceuticals/CRO industry for 10+ years. Skilled in Regulatory Affairs, Quality Assurance, Project Management, Team Leadership, and Project Planning. Strong legal professional with a Bachelor\'s in Pharmacy & a PGDM - MBA focused on Project Operations, from Welingkar Institute of Management, Mumbai University.

Experience

1. Assistant Manager, Regulatory Publishing

   Syneos Health

   Nov 2022 — Present

   Perform Assembler tasks within the document publishing system, creating publications, modifying outline, assigning and transforming documents, and adding cross references, compliance checking, Hyper-linking, bookmarking, rendering multiple documents to PDF, creation of external links, completion of Modules 1-5 in eCTD format, compilation of NeeS, compilation of paper submission, publishing and validation. • Performs Publishing tasks within the electronic publishing system, including, but not limited to, adding special sheets, applying rules, preparing for publishing, and publishing. • Performs QC tasks within the electronic publishing system and QC of the published output, including internal QC and QC of client documentation. • Creates, keys, and assembles client deliverable documents and submissions using standard word processing or publishing systems and utilities (Extedo’s eCTDManager and eSUBmanager, CoreDossier, ISI Toolbox, ISI Publisher, eCTDXpress, eValidator, Acrobat and others). • Takes lead role in preparing full application submission builds. • Line manage staff members. For direct and indirect reports, participate in and manage activities related to department operations such as interviewing, selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, overtime. • Troubleshoots issues with eCTD builds and provide guidance to the entry level publishers. • Reviews documents for accuracy. • Logs and tracks regulatory documents, publications, and other relevant materials. • Receive, deliver client information/documents. • Prepares, assembles applications (INDs, NDAs, ANDAs, DMFs, variations, routine reports, renewals etc.) for submission to global regulatory authorities.

Education

• Welingkar Institute of Management

  PGDM - MBA, Specilaization - Operations

  2014 — 2016

• HVB Global Academy, Mumbai

  Ideal College of Pharmacy and Reasearch, Kalyan, B.Pharmacy, Mumbai University

  2008 — 2012

• St. Xavier's College

  HSC, FYJC and SYJC Science

  2007 — 2008