Priti Kaushik Email & Phone Number

Pune, Mh, In

India

Principal 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.

India

Gurgaon, India (Home Based)

Mumbai (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)

Writing, 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

Responsibilities 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.

Job 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

Mumbai

Worked 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

M.Pharm, Pharmacy

Activities and Societies: Active Member in managing the event "One day seminar on Atomic Energy for the Development of the nation" on Jan.

B.Pharm, Pharmacy