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)