Curriculum Vitae

Sita Vishal Patel

D***, ***0, City Avenue, Philadelphia, PA- 19131

Email abn4i3@r.postjobfree.com

Professional Experience

Overall 12 years of experience in the field of clinical research and

medical writing. Have worked on various document types which including;

protocol, clinical study report, manuscripts, posters, slide decks (topics

as assigned), abstracts, summary level documents (PSUR, ASR, and CTASUR),

base reporting, and regulatory responses. Have worked in various

therapeutic areas such as; Oncology, neuroscience, women health,

cardiovascular, immunology etc Other experience over the 12 year include;

clinical trial operations, medical writing, handling regulatory audits,

external audits, inspection readiness, documentation and quality control,

dossier management, literature search, safety profiling, writing safety

summaries/executive summaries, writing clinical summaries and overviews,

label support (SMPC), RFI and RFP writing, client interaction and interface

and project management. Over these 12 years, the experience is spread

across phase I to phase IV clinical trials and also includes post marketing

and drug development phases. Have a diverse knowledge on guidelines and

training requirement as per the regulatory authorities. Have been involved

in preparation and handling of inspection for regulatory audits (USFDA,

WHO, French, ANVISA, MHRA), sponsor and external audits. In addition have

been a part of client due diligence visits, people panel etc. Further have

been a part of preparing and developing standard operating procedures,

trial master files, dossier documents etc. Experience in clinical research

operations include; being a custodian to the patients, handling Phase-I

studies, handling patient records, trial master file, publishing of

document, internal audits, quality control, etc. Identifying the training

requirement, developing the training material, organizing training and

being a faculty in the training programmes is also an added experience over

this 12 years.

Jan 2013- Accenture Services Pvt. Ltd., Philadelphia, USA

Present Medical Writing Lead

Leading the medical writing team

Handling submissions of PSUR, PEDAR and other

regulatory writing documents.

Handling and devloping scientific slide deck for

various therpeutic areas such as oncology,

neurosciences, immunology, women health, autoimmune

Abstract and manuscripts writing

Standard medical letters

Being client liason

Apr 2011 - Dec Accenture Services Pvt. Ltd., Bangalore (BPO)

2012 Medical Reviewer- Assistant Manager

Drug safety writing

PSUR

PEDAR

PBRER

Medical communications

Handling and devloping scientific slide deck for

various therpeutic areas such as oncology,

neurosciences, immunology, women health, autoimmune

Abstract and manuscripts writing

Standard medical letters

Systematic review of literature search

To do a systematic review of literature search

To prepare the safety profile and executive summary

To oversee the project and do the QC of team members

To manage the project operationally and be capable in

operation of the project

Plan the work organizes the work and see to it that

the deliverables are met.

To train the team with respect to the project and

other guidance during the work

AR frequency for SmPC/CCDS for EMEA (European

regulatory

To code the adverse reactions as per the MedDRA.

To select the studies for updating information in the

label

To calculate the AR frequency

To write the background

To get the operationally capable

Plan the work organizes the work and see to it that

the deliverables are met.

To train the team with respect to the project and

other guidance during the work

Clinical trials reports registration (Base reporting)

Trained in clinical trials base reporting

Reporting pending trials report in clinicaltrials.gov

web site

Publication writing

RFI and RFP development and writing

Sept 2010 to Apr Accenture Services Pvt. Ltd., Bangalore (BPO)

2011 Scientific Writer

Prepare variety of clinical documents (e.g. Common

technical document (CTD) modules, Investigator's

Brochures (IB), Clinical Study Reports (CSRs),

Outcomes research reports and journal articles, and

Bioanalytical reports) based on non-clinical and

clinical studies by organizing, critically examining,

and interpreting scientific and statistical data.

TAs: Oncology, neuroscience, inflammation, women's

health, infectious disease, etc.

Create all documents in accordance to all applicable

Standard Operating Procedures (SOPs), conventions and

client policies.

Plan, organize, and manage daily work to meet service

level timelines and deliverables.

Work with the Scientific Writing team lead to escalate

issues or tasks outside the normal scope of work.

Project management and take document to completeness

and get the work executed from other medical writers

Quality control check of varied documents to ensure

that the document matches the source data, regulatory

requirements

Oct 2009 to Sep Accenture Services Pvt. Ltd., Bangalore (BPO)

2010 Medical Writer

Worked primarily in Oncology, Neuroscience, Women's

Health, infectious disease, virology and Inflammation

therapeutic areas.

Prepare variety of clinical documents (e.g. Clinical

Study Report (CSRs), Summary Documents:

Investigational new drug application annual reports

(INDARs).

Review of all documents in these therapeutic areas.

Communicate project details/status to the client.

Work effectively with other writers, communicating

project (in therapeutic areas other than Inflammation

and Vaccines) information in a timely manner.

Responsible for the quality and timeliness of

documents produced for the project.

Work to ensure documents are of high quality,

scientifically accurate, meet company standards and

regulatory requirements (eg, SOPs international

conference on harmonization [ICH] and food and drug

administration [FDA] guidance) as per SLAs.

Conducting the review of the documents written by

peers (in therapeutic areas other than inflammation

and vaccines).

Train newly joined hires on clinical writing. Develop

programs for new and experienced resources in

conjunction with training team. Identify additional

training needs and assist in planning to address them.

Apr 2006- Oct Lambda Therapeutic Research

2009 Medical Writing & Publishing work

Have broadly worked in oncology, anti inflammation,

women's health, anti diabetic, anti inflammatory, anti

histamic, neuroscience, anti epileptic, and

antipsychotic.

Have an experience in writing the following documents:

Writing Clinical Study Reports - Phase-I, II and III,

bioavailability/bioequivalence (BA/BE) reports,

investigational reports, other section of report (CTD

tables, section 2.7 as required by electronic e (ctd)

format.

Worked on Therapeutic Areas for Phase-I: anti

diabetic, anti inflammatory, anti hypertension.

Worked on Therapeutic Areas for Phase-II: anti

inflammatory, anti hypertension.

Worked on Therapeutic Areas for Phase-III: anti

infections (PK Based Phase III trial report) and

oncology (efficacy study report).

Regulatory bodies covered: FDA submission, european

(EU) submission, Brazilian submission, and Indian

submissions.

Writing Protocols - Phase-I, Phase-III

(pharmacokinetic [PK] based), and BA/BE protocol

(Prospective as well as retrospective study protocols

covered).

Therapeutic Area: Broadly worked on anti-epileptic,

antipsychotic, anti inflammatory areas.

CRF Designing: Phase-I, II, III, special studies,

bioequivalence studies.

Designing Electronic case report forms (CRF).

Writing Safety narratives

Preparing CSR templates for different clients

Preparing "Appendices" of the Clinical Study Report

Publishing

Publishing document which include; dossier management,

arranging the documents as per regulatory requirement

(Common technical document & eCTD- Module 1 to Module

5), compiling the document, numbering the documents,

formatting, getting the document submission ready

Writing clinical summaries /efficacy and safety

summaries and overviews as a part of the dossier

Preparing the trial master file and maintain it.

Drafting and submitting regulatory responses.

Inspection readiness

Checking the document once the dossier is submitted

for any future regulatory inspection

Mar 2000 - 2006 Lambda Therapeutic Research Ltd,- Ahmedabad (CRO)

Clinical Research

Clinical Custodian - Been a custodian to the patients,

maintained patients records like, case reports, lab

reports, treatment records, discharge summaries etc.

Quality control - Set up the quality control team.

Performed quality control of various documents such as

patients safety records, patients in house records,

case reports, protocols, narratives, medical records,

laboratory reports etc.

Audits: Been a part of various regulatory audits such

as US FDA, French, ANVISA, MHRA, WHO. Faced the audit

with the principal investigator and the team.

External Audits- Been a part of the external audit

team for preparing the individual departments for

inspection readiness. Audited all sort of

documentation present for the trials such as training

records, training logs, patient records, regulatory

related documents. Experience of monitoring clinical

trials as part of sponsor delegated responsibility.

Training - Involved in training activities starting of

identifying training needs, developing training

material, organizing training programmes and

conducting training programmes. Topics covered in

training included; basic clinical research, ICH

guidelines, audits, medical writing, quality controls,

monitoring in clinical trials, history of GCP etc.

Have set up a training unit in Poland facility (branch

office).

Maintaining Trial Master file

Project Management and Client interface - Day to day

interaction with clients, client audits, due diligence

etc.

SOPs- Identified requirement of SOPs and developed

SOPS

Educational Qualification

Education Year: : 1996 - University: Gujarat university

1998

Degree: Bachelor of Arts

Education Year 2006 -2007 Bharathiya Vidya Bhavans University,

Ahmedabad

Diploma - Diploma in journalism

Languages English, Hindi, Tamil, Gujarati

Known

Visa Status - Green card (permanent resident)

Available - Immediately

Reference upon request - Dr. Mohan Bangalore (abn4i3@r.postjobfree.com)

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