Amareswara Reddy Gangula

Novartis

03.2023 - Current

Prepare/Review of regulatory documents [such as, Clinical Study Protocols/Amendments, Clinical Study Reports (CSRs), Investigator Brochure (IB)/Updates, Informed Consent Forms (ICFs) and contribute to CTD summaries
Review/Check of the source documents received and prior intimation for any additional requirement of the documents
Strict adherence to templates, style guides and addressing comments at each draft stage
Provide training and mentoring to new regulatory writers and associates as required

MMS Holdings

12.2020 - 02.2023

Independently authored high quality regulatory documents including Clinical Study Reports (Phase 1 to 3, FDA & EMA submissions), Clinical Study Protocols, Summary documents (SCS, SCE, CO and Synopses of Individual studies), IB, Summary of changes (protocols and IB) and various other regulatory documents as per request
Coordination of inputs from contributors, comment incorporation, facilitation of QC and document finalization within set timelines
Efficient in understanding MS word toolbars and styles of writing for various document types
Proficient with client templates and style guides
Addresses client comments during document life cycles and provides value added suggestions, comment resolution logs as needed, communicates important decisions to team and manages revisions
Assumes responsibility for quality and integrity of documents
Conducts thorough self-review of deliverables prior to release to client

Accenture Services Private Limited

10.2015 - 04.2020

Drafting and review of Clinical Study Reports, Protocols, SASUSAR/ INV SASUSAR reports, Summary documents, Investigator’s Brochures, narratives for CSRs, and other regulatory documents.
Data validation and checking the accuracy of data required for analysis
Review and identify the literature that is selected for inclusion in the regulatory document
Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields
Addressing the health authority requests as per the timeliness
Submission of the final reports as per the timeliness provided by the client
Ensures all the study related groundwork is done for the writers to draft narratives (CSR)
Preparation of narrative track sheet (NTS) and monitor the progress of study
QC of narratives post drafting, providing feedback and quality scoring
Master list compilation for client submission
Ensures that team functions are aligned to meet service level timelines and deliverable

Summary