Manager Microsoft Office

NITASHA R. PHATAK, M.D, PH.D.

**** ******** ****** # ****, **** WORTH, TX 76107 817-***-**** acvsu0@r.postjobfree.com https://www.linkedin.com/in/nitasharphatak

SUMMARY

As a team member of Global Regulatory Affair-Labeling (Safety Updates), reviewed various product labels for safety updates in Catalyst. Additionally, assisted in the development of Core Company Data Sheet (CCDS) supporting documentation, Basic Patient Leaflet (BPL) and Quality Control, Compliance in iMedidata and Catalyst. Comprehensive ophthalmic surgical as well as clinical experience of 8 years with research experience in Visual sciences. Experience in clinical research trials as an Intern. Proven ability to be a detail-oriented and communicate in research and medical fields professionals. Analytical and detail- oriented with writing skills in manuscript publications, abstracts. A team player, able to multi-task and prioritize work assignments with organization. Key areas of expertise:

1. Global regulatory affairs (Pharmacology) 2. Safety labeling and Quality Control, Compliance 3. Catalyst, iMedidata and DCM (Documentum Compliance Manager Efficiency 4. Ophthalmic procedures and surgeries 5. Pharmacology and Medical terminology

EDUCATION AND RESEARCH

DOCTOR OF PHILOSOPHY, BIOMEDICAL SCIENCES: 2009-2015 University of North Texas Health Science Center, Fort Worth TX Visual Sciences (Ophthalmology)

DIPLOMA IN OPHTHALMIC MEDICINE AND SURGERY: 1999-2001 University of Mumbai, Mumbai, India

BACHELOR OF MEDICINE AND BACHELOR OF SURGERY: 1992-1998 University of Mumbai, Mumbai, India

PROFESSIONAL AND RESARCH EXPERIENCE

Global Regulatory Labeling Reviewer (Safety Updates), Feb 2016- Present Alcon, a Novartis Company, Fort Worth, TX

Provided detailed review of product labels and documents summarizing label changes for required safety updates to existing Novartis-Alcon labeling

Performed an in-depth research on cSLT, SmPC, BPL, and country specific regulatory requirements for Alcon’s products

Strong working knowledge of SharePoint, catalyst, iMedidata, and Documentum

Assisted for quality control and compliance (Product labels) in iMedidata and Catalyst

Assisted in the development of CCDS supporting documents, PIL (Patient Information Leaflet) to BPL (Basic Patient Leaflet) conversions in Documentum Compliance Manager (DCM) Intern - Clinical Research – Office of Clinical Trials, Sept 2015- Jan 2016 UNT Health Science Center, Fort Worth, TX

Worked closely with principal investigators, clinical research coordinators, and study staffs to ensure trials are completed in compliance with standard operating procedures (SOPs), FDA regulations and good clinical practice (GCP) guidelines.

CITI training

NITASHA R. PHATAK, M.D, PH.D.

3221 DONNELLY CIRCLE # 1805, FORT WORTH, TX 76107 817-***-**** acvsu0@r.postjobfree.com https://www.linkedin.com/in/nitasharphatak

Introduction to Federal regulations and good clinical practices (GCP) guidelines Research Assistant – UNT Health Science Center, Fort Worth, TX 2009-2015

Creatively designed and conducted innovative scientific experiments in individual and team settings leading to quality, reproducible data

Conveyed findings via detailed reports to both expert and lay audiences as seen by my publication and presentation history below

Designed and produced publication qualify images for manuscripts and presentations

Simultaneously, developed, organized and managed multiple experiments/tasks at various stages of completion including mentoring several undergraduate student research project Consulting Ophthalmic Surgeon

Samta Hospital, Dombivli, Mumbai, India 2001-09

Manav Kalyan Kendra’s CHARITABLE Hospital 2003-09

Gurukul Preparatory School 2004-08

Laxmi Eye Institute, Mumbai 2007-09

Kalyan-Dombivli Municipal (COUNTY) Hospital, Maharashatra, India 2003-06 Work Experience and responsibilities as an Ophthalmic Surgeon:

Responsible for County and Private Ophthalmic Outpatient Department (Profit and non-profit organizations) with various teams with diverse educational background and an average of more than 50 patients daily

Assessed and managed patients with neurological disorders like idiopathic optic neuropathies, optic atrophy, and optic nerve injuries

Assessed and managed patients with refractive errors, contact lenses, dry eyes, red eye conditions, injury patients, infectious and allergic eye conditions, with systemic diseases like diabetes mellitus, hypertension, rheumatoid arthritis, uveitis, post-operative patients, glaucoma, squint, optic nerve disorders

Anterior and posterior segment examinations of eye: vision tests, retinoscopy, direct and indirect ophthalmoscopy, slit-lamp examination, Fluorescent angiography, gonioscopy, applantation tonometry, Yag-laser capsulotomy, B-scan.

Operated on more than 1000 (annualized) Cataract surgery with Phacoemulsification, IOL implantation, Trabeculectomy, Penetrating Keratoplasty, Lacrimal sac surgeries, Enucleation, IntraVitreal injections, Vitrectomy, Lensectomy, Pterygium exicision and Chalazion Excision.

Assisted renowned retinal surgeon from Mumbai for retinal detachment surgery with laser application and vitrecotmy with silicone oil injections and insertion of retinal band

Performed A-scan and Keratometry

Conducted and managed Optometry and Contact lens Clinic

National Pulse Polio Program – Team leader with a staff of five PROFICIENCIES AND TECHNICAL SKILLS

Software: Catalyst, iMedidata, Documentum Compliance Manager (DCM), Microsoft Office Suite (Word, PowerPoint, Excel), OneNote, Endnote, Adobe Photoshop NITASHA R. PHATAK, M.D, PH.D.

3221 DONNELLY CIRCLE # 1805, FORT WORTH, TX 76107 817-***-**** acvsu0@r.postjobfree.com https://www.linkedin.com/in/nitasharphatak

a) Highly motivated person who can work independently or in a team environment b) Ability to communicate effectively orally as well as in writing c) Ability to handle pressure and meet deadlines

MANUSCRIPTS AND PUBLICATIONS

Nitasha R . Phatak, Do r o t a L . Stankowska, Raghu R . Krishnamoorthy. Transcription f a c t o r B r n -3b overexpression enhances neurite outgrowth in PC12 cells under condition of hypoxia. Cell and Mol Neurobiol. 2015 Aug; 35 (6):769-83. doi: 10.1007/s10571-015-0171-0 Alena Z. Minton, Nitasha R. Phatak, Dorota L. Stankowska, Shaoqing He, Hai-Ying Ma, Brett H. Muller, Ming Jiang, Robert Leudtke, Shaohua Yang, Colby Brownlee, Raghu R. Krishnamoorthy. Endothelin B Receptors Contribute to Retinal Ganglion Cell Loss in a Rat Model of Glaucoma. PLoS ONE 2012; 7(8):e43199. doi:10.1371/journal.pone.0043199

Dorota L. Stankowska, Alena Z. Minton, Margaret A. Rutledge, Brett H. Muller, Nitasha R. Phatak, Shaoqing He, Hai-Ying Ma, Micheal J. Foster, Thomas Yorio and Raghu R. Krishnamoorthy. Neuroprotective effects of transcription factor Brn3b in an ocular hypertension rat model of glaucoma. 2015 Jan 13; 56(2):893-907. doi: 10.1167/iovs.14-15008

MANUSCRIPTS SUBMITTED

Nitasha R. Phatak, Dorota L. Stankowska, Raghu R. Krishnamoorthy. Changes in the expression of Bcl-2 family proteins after overexpression transcription factor Brn3b in ocular hypertension model of glaucoma. POSTER PRESENTATIONS

Nitasha R. Phatak, Dorota L. Stankowska, Raghu R. Krishnamoorthy, Overexpression of the POU Domain Transcription Factor Brn3b leads to Upregulation of the Prosurvival Factor Bcl2 in Rat Retinal Ganglion Cells. Denver, CO (ARVO 2015)

Nitasha R. Phatak, Dorota L. Stankowska, Raghu R. Krishnamoorthy, Overexpression of the POU Domain Transcription Factor Brn3b causes Neurite Outgrowth in Cultured PC12 cells Under Condition of Oxygen Glucose Deprivation. Orlando, FL (ARVO 2014)

Nitasha R. Phatak, Dorota L. Stankowska, Raghu R. Krishnamoorthy, Overexpression of the POU Domain Transcription Factor Brn3b causes Neurite Outgrowth in Cultured PC12 cells Under Condition of Oxygen Glucose Deprivation. Research Appreciation Day, UNTHSC, Fort Worth 2014 Nitasha R. Phatak, Dorota L. Stankowska, Raghu R. Krishnamoorthy, Overexpression of POU Domain Transcription Factor Brn3b causes Neurite Outgrowth in Cultured PC12 cells. Seattle, WA (ARVO 2013) Nitasha R. Phatak, Dorota L. Stankowska, Raghu R. Krishnamoorthy, Brn3b Overexpression Promotes Axon Outgrowth in 661W Neuronal Cell Line. Fort Lauderdale, Florida, (ARVO 2011) Nitasha R. Phatak, Dorota L. Stankowska, Raghu R. Krishnamoorthy, Brn3b Overexpression Promotes Axon NITASHA R. PHATAK, M.D, PH.D.

3221 DONNELLY CIRCLE # 1805, FORT WORTH, TX 76107 817-***-**** acvsu0@r.postjobfree.com https://www.linkedin.com/in/nitasharphatak

Outgrowth in 661W Neuronal Cell Line. UNTHSC, Fort-Worth, (AOPT 2011)

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