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ac4um6@r.postjobfree.com +1-609-***-**** Plainsboro, NJ

Work Experience

Freelance writer & editor

**/**** – Present

Project Physician Associate (Medical

Writer)

Clinigene International Limited

07/2012 – 11/2013 Bengaluru, India

Project Leader/ Documentation Executive

Clinigene International Limited

09/2010 – 06/2012 Bengaluru, India

Clinical Research Coordinator

KLE's hospital & medical research centre

11/2008 – 03/2010 Belgaum, India

Accomplishments

Authored 80+ BA/BE and Phase 1 protocols

Prepared 100+ Case report forms

Prepared 100+ Informed consent forms

Authored 10+ Clinical Study Reports

Authored 14 department SOPs

Authored 7 publications

Education

Master of Pharmacy (Pharmacy Practice)

KLES’s College of Pharmacy

2008 – 2010 Belgaum, India

Bachelor of Pharmacy

Visveswarapura Institute of Pharmaceutical

Sciences

2003 – 2007 Bengaluru, India

Eligibility to work in USA

Currently have Employment Authorization

Document (EAD) card on L2 visa. Do not

require sponsorship to legally work in USA.

Skills and Competencies

Excellent writing skills- Logical and succinct

with accurate data interpretation and

representation.

ICH GCP trained

Domain knowledge of varied therapeutic

areas and regulatory/scientific guidelines

Excellent attention to details

Effective communication

Highly organized & respect metrics driven

timelines

High performing & Innovative

English Proficiency

TOEFL iBT Score- 115/120

Reading-30, Listening-30, Speaking-26, Writing-29

Publications

Impact of Educational Interventions on

Adverse Drug Reaction Reporting. Indian

Journal of Pharmacy Practice, Jan 2011.

[Research Paper]

Pharmacist: A crucial part of Clinical

research. Journal of Pharmacy Research, Mar

2010. [Review]

The Real Problem: Non Adherance. Panache

Live Issue 5. Mar 2010. [Review]

Attitude and Knowledge of Healthcare

Professionals for ADR Reporting in Tertiary

Care Hospital. Indian Journal of Pharmacy

Practice Vol. 2(4). Oct- Dec 2009. [Research

Paper]

Pharmacogenomics-A Rising Perspective.

Indian Journal of Pharmacy Practice Vol. 2(2).

Apr-June-2009. [Review]

Combating the menace of counterfeit drug

terrorism. Pharmabizz Chronicle 2009.

[Review]

Pharmacist and Personalized Medicine.

Pharmabizz Chronicle 2008. [Review]

Nidhi Shah

Medical Writer & Editor

Being a clinical research professional with strong experience in medical writing, clinical site handling and project management in clinical pharmacology studies, I wish to work in a challenging atmosphere that provides ample opportunity for learning and growth. 2

Job Responsibilities

Freelance writer & editor

Providing writing and editing services.

Writing consumer buying guides for an e-commerce company.

Provided manuscript editing services.

Synthesize, collect and edit clinical content for educational offerings. Project Physician Associate (Medical Writer)

Compile, write and edit medical writing deliverables [clinical trial protocols, clinical study reports, case report forms, investigator's brochures and informed consents] covering all phases of clinical research and wide range of therapeutic areas.

Interact with cross functional teams as necessary to produce clinical trial related documents.

Responsible for researching and writing synopsis and protocols for BA/BE and Phase 1 to 3 clinical trials as per regulatory and sponsor requirements.

Responsible for researching, writing and editing clinical reports, summarizing clinical data from clinical studies for submissions to the regulatory bodies.

Responsible for managing the document review process

Support the development of departmental infrastructure by establishing SOPs, generating templates & processes for developing protocols, investigator’s brochures and clinical study reports.

Participate in project team meetings to provide input regarding deliverables, timelines and processes.

Wrote new SOPs and revised existing SOPs and work instructions for clinical development department Project Leader / Documentation Executive (Medical Writer) Project Leader:

Responsible for planning, management, controlling and documentation of the studies.

Preparation of draft protocols and planning of clinical studies.

Coordinate between sponsor's representative to finalize the protocol, obtain investigational products and other relevant correspondences.

Coordinate between Principal Investigator/ Clinical investigator and IEC for study approval. Preparation and submission of IEC dossiers.

Coordinate with central laboratory for project management and execution.

To manage logistics for the conduct of the study.

Responsible for obtaining and maintenance of study related documents.

To coordinate with the quality control and quality assurance department for the smooth conduct of the clinical study and to provide all relevant documents for audit.

To coordinate with quality assurance department for external sponsor audits and other regulatory inspection.

Documentation Executive (Medical Writer):

Preparation of Protocols & Informed consent forms as per regulatory and sponsor requirements.

Preparation of Case Report Forms and other clinical study related documents as per protocol.

Preparation of Clinical study reports after the study completion. Clinical Research Coordinator

Co-ordinate all trial related activities at site like patient visits, IP handling (Storage, Dispensing and accountability), Biological samples handling (Collection, processing and shipment).

Operating IVRS and IWRS, maintenance of Source Data & Transcription of data in eCRF, updating and maintaining the study site file and progress reports, resolving Data Clarification Forms (DCFs)

Submissions of trial related documents to Ethics Committee, reporting of Adverse Events & Serious Adverse Events to the Sponsors and Ethics Committee 3

Declaration

I hereby declare that all information furnished above is true to the best of my knowledge and belief. Date: 12-Mar-2018

Place: Plainsboro, NJ Nidhi Shah

Contact this candidate