Priti Kaushik Email and Phone Number
Registered pharmacist with 17+ years of medical writing experience in the pharmaceutical industry. I have experience in writing and managing the common technical documents (CTD) for submissions & publications for pharmaceuticals & research organizations. I have managed and mentored a team of medical writers. I also have extensive experience in the writing, quality control and peer review as per the International Council for Harmonisation standards of the following:• Clinical Study Reports (Phase 1-4): synoptic, abbreviated, full, and non-interventional;• Clinical Evaluation Reports;• Individual patient narratives;• Protocols, including amendments;• Expanded access protocol;• Investigator brochures (IBs);• Patient information sheets; • Informed consent forms (ICFs), including amendments;• INDs-clinical and nonclinical writing; • NDAs and BLAs;• Global value dossiers; • Plain language summaries;• Brand building material. Experienced in writing drug application dossiers, global value dossiers, case narratives, research papers, journal articles, scientific reviews, short communications, detailing aids, conference & educational materials, and SOPs.Serves as primary author who writes and provides input on commercial and branding documents which includes continuing medical education (CMEs) for physicians, gap analysis, electronic detail aid for physicians, product education material for marketing team, product brand campaign development. • United Kingdom (UK) and United States (US) contracts working experience Therapeutic Areas (No Limitations): Oncology, Immuno-oncology, Anti-infectives, Cardiovascular, Neuroscience, Dermatology, Diabetes, Endocrinology, Musculoskeletal, Ophthalmology, and Respiratory Medicine, Orphan drug, Biologicals, Vaccines. Priti KaushikPrincipal Medical Writer priti.zonap@gmail.com; preet4u11@gmail.com
Contracting/Freelancing
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Independent Consultant - Principal Medical Writer And EditorContracting/FreelancingPune, Mh, In
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Independent Consultant - Principal Medical Writer & EditorContracting/Freelancing Apr 2020 - PresentIndiaPrincipal Medical Writer• Provides high-quality medical and scientific writing from planning through delivery of final drafts to internal and external clients. Establishes and develops client relationships; independently initiates and leads interactions with clients.• Serves as primary author who writes and provides input on commercial and branding documents which includes continuing medical education (CMEs) for physicians, electronic detail aid for physicians, product education material for marketing team, product brand campaign development. • United Kingdom (UK) contracts working experience through UK based recruitment agency.• Serves as primary author who writes and provides input on complex clinical and scientific and program level documents, including IBs, DSUR, INDs-clinical and nonclinical modules, and MAAs. Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies.• Provides advice on document development strategy, regulations, and industry best practices• Provides subject matter and therapeutic area expertise. • Client contracts and medical writing activities management.
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Executive DirectorZonap Engineering Aug 2016 - PresentIndia
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Principal Medical WriterPpd Apr 2019 - Apr 2020Gurgaon, India (Home Based) -
Senior Medical WriterPpd Aug 2013 - Mar 2019Mumbai (Home Based)Working as Lead Medical Writer on assigned projects including managing the operating budgets and serve a lead resource to work on complex projects.Interacting with Sponsors to discuss project details and their preferences in deliverables. Mentoring new medical writers across APAC countries and serve as resource leads for development of local business opportunities for the company.Writing, reviewing, and editing medical writing deliverables.Regulatory medical writing deliverables include: clinical study protocols and clinical protocol amendments, clinical study reports, clinical overviews, efficacy and safety summaries, investigator’s brochure-new and update, briefing package for regulatory authorities, safety narratives, regulatory response, risk profile, IND summaries, ISS, RMP, PSUR, and DSUR.Commercial medical writing deliverables include: Manuscripts-primary and secondary, abstracts, posters, response to physicians, and slide sets. Ensuring quality and consistency within scientific documents. Participating in project timelines development, standards, budgets, forecasts, and contract modifications.Collaborating with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.Providing technical consultation and substantive advice on strategy, regulations, and industry best practices and maintaining familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.Training received: Professional Skills Program – EDGE (Engage, Develop, Grow, Excel)
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Senior Medical WriterInventiv Health Clinical, Pharmanet/I3 Jan 2012 - Jul 2013Writing, reviewing, and editing medical writing deliverables:• Clinical study protocols and clinical protocol amendments• Clinical study reports• Safety Narratives• ISS and ISEs• Appendix 16• Manuscripts• Regulatory responseReviewing statistical analysis plans and table/listing/figure specifications for appropriate contentQuality control reviews of IBs, protocols, CSRs, subject narratives, ASRs, ISSs, and ISEs Interacting with staff members in medical affairs, data management, biostatistics, and regulatory affairs to ensure all medical writing deliverables are ICH/GCP compliant -
Medical WriterInc Research Dec 2009 - Dec 2011Responsibilities include: Writing, reviewing, and editing medical writing deliverables: Clinical study protocols and clinical protocol amendments, clinical study reports, safety narratives, Appendix 16.Reviewing statistical analysis plans and table/listing/figure specifications for appropriate content.Quality control reviews of IBs, protocols, CSRs, subject narratives, ASRs, ISSs, and ISEs.Interacting with staff members in medical affairs, data management, biostatistics, and regulatory affairs to ensure all medical writing deliverables are ICH/GCP compliant. -
Medical Writing AnalystKinapse Jan 2008 - Dec 2009 -
AnalystKinapse Ltd Jan 2008 - Dec 2009Job Responsibility : Kinapse provide services to top global pharma companies information processing, Business Transformation Consulting and Asset Value Consulting. Kinapse Ltd. has three main offices at Gurgaon, U.K and US. It deals majorly with top 10 global pharma companies and most of my projects are for Top 5 global pharmaceuticals only. Job profile: Overall I have hands of experience on many projects which involves extensive literature review of the documents provided by the client and also through authentic websites.Experienced in Clinical Study Reports (Full CSR, Abbreviated CSRs, Synopsis CSR, Pharma Web Synopsis, Brief Textual Summary)Investigator's BrochureSafety NarrativesClinical OverviewsTherapeutic Area Initiatives: Extensive literature search and power-point presentation preparation of major key therapeutic areas for new business development purpose.Detail Aid presentation referencing and editing for regulatory submission.Literature reviewsBusiness Development InitiativesManuscript Writing
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Trainee ScientistIpca Labs Jul 2007 - Dec 2007MumbaiWorked in BA/BE department for 6 months.Job Responsibility : Writing, reviewing, and editing of various Bioavailability/Bioequivalence documents:•Standard operating procedure•Clinical trial protocol•Feasibility report •CRO Database Preparation–CROs in India for BA/BE studies•Literature review and manuscript preparation from a clinical study report
Priti Kaushik Education Details
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KnmiperPharmacy
Frequently Asked Questions about Priti Kaushik
What company does Priti Kaushik work for?
Priti Kaushik works for Contracting/freelancing
What is Priti Kaushik's role at the current company?
Priti Kaushik's current role is Independent Consultant - Principal Medical Writer and Editor.
What schools did Priti Kaushik attend?
Priti Kaushik attended Birla Institute Of Technology And Science, Knmiper.
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Priti Kaushik
Deputy Manager - Procurement -Gls Films Industries Handing Granules And Solvent //Ex-Emp. Jindal Group/Mandovi River Pellets//Aero Plast //Packaging IndiaBilaspur -
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