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Medical Industrial Training

Location:
Littleton, Colorado, United States
Posted:
October 22, 2018

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Resume:

Rajani Pobba, PhD, M. Pharmacy

*** * ******** ******, **** 1117, Highlands Ranch, Colorado-80129

Mobile: +1-720-***-****

Email: ac7gcc@r.postjobfree.com

Summary

Pharmaceutical medical writing professional with 9 years of regulatory medical writing experience, written summary documents for United States Food & Drug Administration (USFDA), and European Medicines Agency (EMA) submissions

Good subject knowledge and working experience in various medical writing deliverables (clinical study reports (CSRs), patient narratives, briefing documents, Investigator Brochures (IBs), Common Technical Document (CTD), clinical trial protocols, Integrated Summary of Efficacy (ISE), Integrated Summary of Safety (ISS), Summary of Clinical Safety (SCS), disclosure forms, publications etc.)

Strong understanding of pharmaceutical development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, project management and medical terminology

Good time and project management skills

Self-confidence, strong critical and logical thinking with ability to analyze problems, identify alternative solutions and implement recommendations for resolution

A self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment

Professional Experience

Organization: Novartis

From: July 2017 – July 2018

Position: Senior Medical Writer

Key Responsibilities and Experience Gained:

Authored and contributed to critical USFDA submission documents such as CSRs (mainly Phase III), clinical overview (CO) and SCS

Participated, and contributed in the planning of analysis and data presentation to be used in clinical study reports

Acted as a member of clinical trial teams following protocol finalization

Acted as project medical writer in clinical development and ensured medical writing resources within these programs

Contributed to process improvement initiatives

Responsible for writing regulatory documents for dermatology, neuroscience, cardiovascular and respiratory therapeutic areas (ISS, ISE, risk management plan (RMP), DSUR, briefing documents, and CTD summaries etc.)

Co-authored development safety update report (DSUR)

Organization: MMS Holdings

From: Jul 2014– January 2016

Position: Subject Matter Expert

From: August 2011-Jun 2014

Position: Senior Team Lead

Key Responsibilities and Experience Gained:

Wrote submission CSRs for drugs and biologicals and contributed to IB updating, 120 Day safety update reports, ISS, ISE, SCS, briefing documents, narratives, and publications

Generated high quality narratives for various studies

Handled QC for CSRs, protocols, ISS, ISE, SCS, CO, RMP, response to health authority questions, and narratives

Trained and mentored new team members

Participated in the protocol development

Authored publications

Organization: Cognizant Technology Solutions

From: March 2011 – August 2011

Position: Analyst – Medical Writer

Key Responsibilities and Experience Gained:

Performed medical writing activities on assigned protocols

Prepared CSRs and narratives, and effectively coordinated with study teams to produce high quality documents

Generated queries to clarify and improve the quality of the data

Performed quality control checks/peer reviews

Authored web synopsis and CTD narratives

Organization: Makrocare Clinical Research

From: October 2009 – February 2011

Position: (Medical Writer)

Key Responsibilities and Experience Gained:

Participated in literature search and protocol development for vaccine trials for a leading pharma client

Authored CSRs, narratives and summary documents (SCS and SCE) and coordinated medical writing activities

Performed peer reviews to improve the quality of various medical writing deliverables

Wrote manuscripts for Investigator-initiated trials

Organization: Clinical Research and Biosciences

From: October 2007 – October 2009

Position: Research Associate (Medical Writer)

Key Responsibilities and Experience Gained:

Prepared protocols and amendments for pharmacokinetic studies

Authored clinical study reports as per ICH E3 Guidelines

Developed SOPs and Work instructions

Contributed to informed consent forms (ICFs), CRFs (Case Report Form), and other related documents required to submit for Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approval

Educational Qualification

PhD in Pharmacology at Jawaharlal Nehru Technological University (JNTUA)

Masters in Pharmacy (Pharmacology) at Annamalai University

Bachelors in Pharmacy at Sri Padmavathi Mahila University

Industrial Training and Project

Industrial Training:

Underwent Industrial Training at Hetero Drugs Limited

Project (M.Pharmacy):

The project titled “Evaluation of Anti-inflammatory and Analgesic activities of Smilax chinensis” was carried out at Annamalai University.

Project (PhD):

Evaluation of anticancer activity of Orthosiphon aristatus and Cipadessa baccifera. In vitro and in vivo studies were conducted to assess the antioxidant and cytotoxic activities of alcoholic extracts of O. aristatus and C. baccifera. In-vivo antioxidant and anticancer activities were also tested in appropriate rodent models.

Publications

Evaluation of Antioxidant and Anticancer Activities of Cipadessa baccifera

http://innovareacademics.in/journals/index.php/ajpcr/article/view/7700 September 2015

Phytochemical Characterization and GC-MS Analysis of Methanolic Extracts of Cipadessa baccifera and Orthosiphon aristatus

http://jpc.stfindia.com/isuue9_2.html April 2015

Evaluation of anticancer activity of Orthosiphon aristatus

http://pharmascope.org/ijrps/index.php/announce/viewarticle/519 2015

Evaluation of antioxidant and anticancer activities of Orthosiphon aristatus (Blume)

http://pharmascope.org/ijrps/index.php/announce/review/v/6/i/2/ 2015

Anti- inflammatory and analgesic activity of Smilax chinensis http://www.rjpbcs.com/2010_1.2.html

Personal Traits

Flexible attitude and a quick learner

Sincerity and honesty towards the objectives

Excellent verbal and written communication skills

Ability to work hard and to volunteer responsibilities in line with organizational goals

Computer Skills

Advanced working knowledge in

MS-Windows

MS-Office

MS-Visio (for drawing flowcharts)



Contact this candidate