i am an enthusiastic, young Medical Writer with a master’s degree in molecular Medical Microbiology.
i develop narratives and lead narrative writing projects, mostly for Phase 2 and 3 Clinical trials. i assist in drafting regulatory documents such as Clinical study reports, Informed Consent forms and Investigator’s brochures for different sponsors, in collaboration with stakeholders across the globe. i also review these documents and assist in Training new writers in narrative writing processes.
through my academic background in Research and professional experience as a writer, i have built strong Project Management and Analytical Skills. my abilities also focus around structuring complex tasks and executing multiple ongoing projects in challenging timelines.
i have a keen eye for detail and i deliver on promises, with an unyielding focus on quality at all times.
“never hope for it more than you work for it” are some words i live by.
Medical Writer Bangalore, Karnataka, IndiaOctober 2014 --- May 2016
roles and responsibilities
- regulatory writing
- lead author for narrative writing projects
- developed narratives and Informed Consent forms
- assisted in drafting Investigator's brochures and Clinical Trial protocols
- performed internal review of Clinical Trial reports, protocols and annual nda reports
- ensured all documents complied with internal standard operating procedures and ICH guidelines
- project coordination, narrative writing
- developed internal timelines
- sourced style guides, listings, source documents and other project essentials from the client
- prepared project specific template
- guided teams of 6-8 writers
- matched team members’ strengths to specific task requirements on a matrix
- outlined clear expectations for the team
- brought each team Member up to speed with project scope
- assisted in Training new writers in narrative writing processes
- conducted final reviews to ensure reports’ adherence to client expectations
- communication proficiency
- possess highly developed Communication Skills
- maintained constant communication channels across departments (medical reviewers, biostatisticians and Pharmacovigilance teams) to ensure production of high quality deliverables
- participated in meetings with internal and external stakeholders
- Time Management and organisational skills
- successfully managed multiple ongoing projects
- strategized and executed projects in strict timelines
- knowledge of Therapeutic Areas
- possess sound knowledge of various Therapeutic Areas like oncology (non-small Cell lung, hepatocellular, colorectal and ovarian Cancer, adenocarcinoma, melanoma and mesothelioma), Endocrinology (type 2 Diabetes mellitus), Psychiatry (schizophrenia), allergy (allergic rhinitis), Ophthalmology and musculoskeletal disorders (rheumatoid arthritis and chronic low back pain)
AdaptabilityAnalytical thinkingAssertivenessAttention to detailCharmCommunicativeCreative thinkingCoordinationDependabilityDiligenceApproachabilityEfficiencyFlexibilityIndependenceInterest in knowledgeKindnessOptimismProactivityResiliencyResponsibilitySelf-disciplineTrustSociabilityStriving
Biostatistics Cell biology Diabetes Labtechnician Scientific writingAdverse Events (AE)AntibodiesBacteriologyBiological Drug DevelopmentBiologyBiotechnologyCancerClinical researchClinical study reportsClinical Study DesignClinical trialsCommunication SkillsCRFDeveloping Clinical Trial ProtocolsDiabetesDrug development processDrug Safety and PharmacovigilanceeCRFeCTDEnglishEpidemiologyFDAGood Clinical Practice (GCP)Healthcare industryICH guidelinesInfectious diseasesLabtechnicianLeadershipLife SciencesMedical writingMedical DevicesMicrobiological TechniquesMicrobiologyMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft WordNew Drug Application (NDA)oncologyOutlookPharmaceutical IndustrypharmacologyPhase IIPhase IIIPhase IVPhases of clinical development (phase I to IV)PowerPointPre-clinical researchPresentation SkillsProblem SolvingProject CoordinationQuality Control (QC)Report WritingResearchScientific CommunicationsScientific WritingSearch literature on clinical trialsSocial MediaSocial SkillsStandard Operating Procedure (SOP)StatisticsTeamworkTeam ManagementTime ManagementVirologyWriting Study Procedures and SOPs
Skills and Expertise
Analyze data Develop clinical trial protocols Develop protocols Guide students Search literature on clinical trials Write papers Write protocolsCommunicate effectively on different company levelsCommunicate with sponsorConduct literature searchesCoordinationCreate clinical documentsCreate study documentsDetermine needsDirect co-workersInteract with regulatory stakeholdersInteract with statisticiansInterpret dataInterpret scientific dataLiaise with professionals in other divisions of the company as requiredlifescienceMaintain strong relationshipsmanaging a small teamOral presentationOrganise meetingsPlan work to meet objectives and deadlinesPrepare investigator brochuresPrepare regulatory documentsproject managementProvide trainingPublication of articlesQuality control processRead medical literatureSearch literature on clinical trialsUnderstand protocolsWork cross-functionallyWork collaboratively with the other members of the clinical research team Work under specific instructionswrite and maintain clinical evaluation reportsWrite combined statistical and medical reportsWrite papersWriting regulatory documentsWrite documentsWritten presentation
Master in Microbiology from University of Nottingham in 2013
Bachelor in Microbiology from St. Joseph's College in 2012
Training and Certification
Theory and Practice of Biostatistics and Epidemiology in 2014 Certification
Expert has 1 publications (Will be avalible with full profile)