Anju Bala

Experience

• 

  ADI Group

  Jul 2007 - Sept 2014

  Worked on various pipeline, generic and formulations drugs and providing clients related R & D services.Data mining and analysis from pharma companies (GSK, Merck, NOvartis, Allergen etc) website sections like pipelines, news, annual reports, quaterly reports, presentations etcDrug database managementDrug development phases I-IV from Clinicaltrial.gov., NCBI etcNovel, generic, reformulations and biosimilar drugsPatent data extraction from EPO and ESPACENET etcDrug structure, CAS and chemical name searchingTracking drug and maintaining its data from Pre clinical to launched stage including IND, BLA, NDA filings of drugs in world's largest drug markets.Drug database maintenance (information related to generic/brand names of drugs, companies developing the drug, preclinical and clinical studies, drug mechanism, chemical name, chemical formula, diseases, route, medium, technology for which drug is being developed.Trained junior editors by giving them good exposure Show less Provided clinical trial intelligence services to clients including data on various ongoing, completed, terminated pre-clinical & clinical (Phase I-IV) trials related to neurological and ophthalmology indications etcUnderstanding of various clinical trial protocols, Clinical study reports, synopsis and other source documents.Preparation of Clinical Trials Disclosures from clinicaltrials.gov, EudraCT etc of various Clinical Trial studies.Communicating with the clients for their feedback and approval of the study disclosures.Reviewing publically disclosed information such as medical publications from primary sources to ensure consistency of information posted.Regular check of clinical trials disclosure documents for maintaining the quality and avoiding the duplicacy of the documents.Quick addition of first hand dataContinuous updation of existing dataTrain juniour editors Show less Clinical research experience including drug development stages (preclinical to marketing)Work profile including conversion of data to information (coverage of all newly developed and under development drugs from pharmaceutical companies and other sources)•Collect, Extract & analyze the information about marketed & under development drugs of Bio-Pharmaceutical companies including clinical trial data, regulatory information (approvals & filings of NDA, BLA etc), Deal-M&A (mergers & acquisitions), patent updates capture for products & companies from various sources like company websites, regulatory sites, SEC filings, annual reports, scientific journals, healthcare conferences, annual meetings (ARVO etc).•Cover a wide variety of public & proprietary data bases: FDA, EMEA, ClinicalTrials.gov, NCI, CTRI, UMIN, Medscape, PubMed, eSpacenet, Science Direct etc.•Acquisition of data from internet, Case Report Forms (CRFs) & Data Clarification Forms (DCFs).•Data Entry and review processing by other Clinical and Data Management personnel worldwide. •Data cleaning, tracking and updating the database. Show less

  • Medical Writer for drug intelligence services

    Jun 2010 - Sept 2014

  • Clinical Research Associate, CNS/Ophthalmology

    Jul 2007 - Sept 2014

  • Trainer

    Jan 2009 - Jun 2010

  • CLINICAL RESEARCH ANALYST

    Jul 2007 - Jun 2010
• 

  I3CGLOBAL

  Aug 2019 - Jan 2022

  Medical Device Consultant

  CER writing, Risk Management, Biological Evaluation, CE marking as per EUMDR

• 

  Celegence

  Jan 2022 - Dec 2022

  Medical Writer

  CER writing with PMS documentation in compliance with EU MDR

• 

  HCLTech

  Jan 2023 - May 2024

  Technical Lead

  Review of clinical documents (CEP, CER, PMSP, PMSR, PMCFP & PMCFR) in complaint with EU MDR