Summary

Over **+ years of industry experience in Medical writing & Quality Assurance

in clinical research

Experienced in researching, writing, reviewing and editing study protocols,

CSRs, ICFs, CRFs, safety narratives, CMEs, review articles, publication

articles, drug monographs, abstracts

Review of clinical trial data and medical coding (MedDRA and WHODD)

Project Management for CDM projects

Preparation and review of standard operating procedures, Operational

documents, process documents, flow charts and scheduling and conduct of

internal audits.

International exposure - Process Consultant at Stuttgart, Germany

Certified ISO internal auditor as per ISO 9001:2000

Academic Details

Year University / College Qualifications

1998-1999 Rajiv Gandhi University, Govt. Master of Pharmacy -

College of Pharmacy, Bangalore Pharmachemistry

1996 Mysore University, JSS College Bachelor of Pharmacy - Third

of Pharmacy, Mysore rank holder to the University

1996 All India Level competitive Qualified Graduate Aptitude Test

examination of Engineering (GATE)

Currently pursuing

2013 Alison courses Diploma in Project Management

2013 Inquill Medical communications Regulatory writing in US

Professional Experience

Organization, Responsibilities

Designation

Sprim Global Responsible for Medical writing projects especially

Investments Pvt. Ltd. publication writing assignments of APAC region

Impact factor analysis and suggestion of Journal for

01/01/2014 - publication for clients

15/03/2014 Responsible for writing clinical trial protocol, CSR,

Consultant - Medical ICF, CRF design, and other clinical trial documents.

writing operations

(APAC region)

Quartesian LLC Co-ordination of QA activities with functional heads of

Senior Manager - other locations (US/UK/Ukraine) and with external

Quality Assurance customer representatives.

Project Manager Responsible for planning and conduct of internal audits

14/09/2009 -

04/10/2013 Maintain and tracking of CAPA database

Involved in preparation of client proposals and

questionnaires/RFI from potential clients

Internal review of all deliverables - PK report, CSR,

Manuscript, publication articles, DMP, CCG, QCP,

Represent QA at client meetings and audits, liaison

with clients and third party auditors

Responsible for creation of SOPs and process documents

Develop and deliver training to staff to ensure

compliance with regulatory requirements, policies and

Standard Operating Procedure.

Additional project management responsibilities of:

Project kickoff

Creation of project plan based on QCD (Quality, cost

and delivery) objective

Technical problem resolution in consultation with Tech

Leads.

Freelance Medical Writing and reviewing of various medico marketing

Writer products like CMEs, review articles, monographs,

10/09/2009 - Till publication articles, slide kits, abstracts,

date publication articles to various clients in India,

UK and US.

CMP Medica Pvt. Ltd. Medical writing, reviewing and editing of diverse

Freelance Medical medico marketing products like CMEs, newsletters,

Writer review articles for journals, booklets, specialty

01/04/2009 - magazines, product monographs, drug reviews, patient

10/09/2009 education write ups, leave behind literature (LBLs),

visual aids, presentations and case reports.

Manipal AcuNova Ltd. Researching, preparing, reviewing and editing of CSRs,

(01/08/2005 - protocols, CSOs, ICFs, CRFs, safety narratives...

31/03/2009) Review of clinical trial data and raising DCFs

QA Associate, Process Responsible for Medical coding using MedDRA for adverse

consultant events and medical history; and WHODD for medications

(Stuttgart, Germany), and clinical data review.

Senior Medical Writer Single point contact for BA\BE facility of Manipal

AcuNova regarding medical writing and quality aspects.

Responsible for conduct of internal audits across all

functions of the company and providing inputs for

creation of SOPs, process documents, workflows,

policies...

Lotus Labs Pvt. Ltd., Preparation and review of Clinical trial protocols,

ICFs, Clinical Study Reports... and any other technical

Bangalore documents as required.

Head - Clinical Periodically to deliver the status report to the

writing and management and planning on the Medical writing

Pharmacokineticist deliverables.

01/08/2003 - Supervise; provide training and guidance to team

01/07/2005 members of clinical writing.

Representing the team in internal quality audits and

external regulatory audits.

Worked on WinNonlin (Windows based Non Linear System)

for pharmacokinetic and statistical analysis of BA\BE

studies.

Atmedica Pvt. Ltd. Writing, reviewing and editing of CME write-ups,

Bangalore patient education write ups, product monographs, drug

Scientific writer & reviews, visual aids, review articles, presentations

Editor and case reports.

01/08/2001 - Responsible for managing the news letter series of

01/07/2003 multiple specialties like Gynecology, Anesthesiology,

orthopedics scheduled monthly and the journal named

Oncology Progress (Monthly scheduled).

Worked on DBASE Program for CIMS - Current Index of

Medical Specialties.

Krupanidhi College of Lectured for B. Pharm and D. Pharm courses

Pharmacy Taught courses in Advanced Pharmaceutical chemistry,

Department of Medicinal chemistry and Modern Pharmaceutical Analysis.

Pharmachemistry,

Lecturer Conducted labs for courses in Biochemistry and

01/06/1999 - Medicinal chemistry.

01/09/2000

IT Skills

Conversant with: MS Word, Excel, PowerPoint, WINNONLIN, TMS, MedDRA, WHODD

Publications, Training & Memberships

Publication in an international journal (JOURNAL OF MACROMOLECULAR SCIENCE

A PURE AND APPLIED CHEMISTRY) on Chitosan/HPMC Polymer Blends for

Developing Transdermal Drug Delivery Systems.

Research papers presented at IPC:

Rational prescribing practices in the management of asthma- an assessment.

Prescribing pattern of selected diseases - the role of community

pharmacist.

Demographics of selected diseases - the role of hospital pharmacist.

Mock dispensing lab exercises for pharmacy students.

Certified ISO 9001: 2000 internal auditor from CETE, Bangalore

Advanced ICHGCP training by Dr F.P. Crawley, Secretary General, European

Forum for GCP, Bangalore, 2005.

Workshop on Process Validation at Singapore, 2005.

Six Sigma Green belt training, Bangalore, 2005.

Completed a course of study on NT01: Free Clinical Operations GCP and ICH

Training Series: Corrective and Preventative Actions Procedures with a

score of 100% dated October 6, 2009 offered by Tamera Norton Smith, Ph.D.

of The Norton Training Institute for Clinical Research Excellence,

Lexington, SC 29072

Completed Quintiles GCP Module 1 to 6 - CME, 2010.

Completed FDA's training on "An introduction to the Improved FDA

Prescription Drug Labeling".

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