Ruchita Nadkarni

Freelance Report Writer & Proofreader

Location:Plainsboro, New Jersey, United States
2 Skills
15 Heather Ct
Plainsboro, NJ 08536
Home: 609 785 5085
Cell: 973 953 7393

To work for a Pharmaceutical company or a Contract Research Organization (CRO), working in areas related to clinical field trials of new drugs, efficiently and effectively utilizing my skills, experience and knowledge, thereby contributing to the eradication of diseases in various therapeutic areas. I would like to work in a challenging work environment that facilitates the opportunity to grow.

• Masters Degree in Medical Microbiology.

• Excellent verbal & written communication skills and work well independently or as part of a team.
• Detail and multi-task oriented with strong organizational skills.
• Good scientific background and knowledge of Immunology.

• Total No. of Years Experience: 12+ years
Pfizer September 2011 - September 2012
Senior Medical Writer (contract)
• Using appropriate templates and analyzing statistical tables and listings for preparing detailed clinical study reports for Phase 1 or 2 studies as per FDA formats as well as sFDA (China) formats.
• Preparing interim clinical study reports as required for various studies.
• Responsible for preparing pediatric web synopses for legacy Wyeth studies.
• Knowledge of different global document management systems (GDMS; EDMS)
• Working on multiple projects within defined timelines and across different teams.
• Trained in client SOPs.

Freelance Contractor February 2008 - September 2011
Senior Medical Writer
• As Senior Medical Writer support different pharmaceutical clients and manage projects and project timelines and work with cross-functional teams.
• Responsible for preparing detailed clinical study reports for Phase I-IV trials by analyzing and interpreting statistical tables and figures using company defined templates.
• Responsible for preparing Integrated clinical summaries (ISS and ISE) or other modules of a CTD.
• Also responsible for writing safety narratives based on defined templates.
• Preparing and updating IND Annual Reports
• Responsible for the development and update of Investigator Brochure's.
• Working knowledge of document management systems (Documentum, eDMS)
• Trained in client SOPs.

Sanofi Pasteur, Newark, New Jersey, USA September 2006 – February 2008
Senior Medical Writer (contract)
• As Senior Medical Writer support pharmaceutical client Sanofi Pasteur in their post marketing studies of vaccine trials.
• Responsible for interpreting statistical tables and figures to prepare detailed integrated clinical study reports in Documentum for clinical trials Phase I-IV.
• Responsible for preparing Protocols and Amendments to Protocols and updating IND annual reports.

Eisai Medical Research Inc., New Jersey, USA February 2003 – September 2006
Senior Medical Writer (June 2005 – September 2006)
Medical Writer (February 2003 – June 2005)
• Responsible for interpreting statistical tables and figures to prepare detailed clinical study reports for mainly the CNS therapeutic area and other therapeutic areas.
• Responsible for the preparation of Clinical Protocols, using defined templates for the Sepsis, GI, CNS, Oncology and other therapeutic areas.
• Responsible for development or update of Investigator Brochures (IBs).
• Involved in the word processing required during the preparation of the different clinical documents.
• Involved in the electronic Document Management System (eDMS) pilot study and authored/coordinated a Clinical Study Protocol and Clinical Study Report in eDMS.
• Performed QC and peer review on the various clinical documents.
• Interact with Study Directors, Regulatory and Biometrics (as needed) in the preparation of Clinical Study Reports, Protocols and IBs.
• Mentoring other Medical Writers.
• Clinical Data Management Centre India (CDMCI)

GlaxoSmithKline Pharmaceuticals (India) Ltd., Bangalore, India March 1999 – January 2002
Clinical Data Management Centre India
Scientific Writer
Associate Scientific Writer

• Interpretation of statistically analyzed clinical research data to prepare detailed clinical study reports (interim, final, annex) for vaccine studies.
• Interact with cross functional teams across the globe.
• Draft all sections of clinical reports and other clinical documents like protocols and Investigator Brochures following defined templates.
• Writing and updating SOPs, Working Procedures and Corporate Policies.
• Trained new Scientific Writers to work independently.


• Masters Degree in Medical Microbiology
Kasturba Medical College, Manipal, India 1995-1998

• Bachelors Degree in Science
Bangalore University, Bangalore, India 1992-1995
Skills (2) Rating
Report Writing