Customer Service Medical

Pankaj Rajput

H-*/*** Lok Kedar Lokpuram Hsg Soc, Vasant Vihar, Smt G.A. Road, Thane (W),

Mumbai Pin: 400601, INDIA

Cell: +919*********; E-mail: **************@*****.***

A highly proficient and experienced medical writer having around 12 years

of overall working experience, 4 years as Medical Writer (Team Lead for 2

years) in Clinical Research, 3 years as general medical practitioner, and 6

years into Medical Transcription.

Note: Holder of valid H1B visa; petition approved until April 2012.

Academics

* Passed B.H.M.S. (Bachelor of Homeopathic Medicine and Surgery) in 1997

from Mumbai University, Mumbai, India (55%)

* Passed PG Diploma in Clinico-Regulatory and Patents conducted by

PEXA/Center for Advancement in Health Sciences, Mumbai, in February

2007.

* Passed HSC (12th Standard High school) and SSC (10th Standard) with

Mumbai Board with 80.16% and 85.69%, respectively, Mumbai, India.

Work Experience

A. CLINICAL RESEARCH

Employer: Cognizant Technology Solutions India Pvt Ltd, Mumbai, INDIA

Designation: Medical Writer - Team Leader (March 2009 to date)

Key Responsibilities:

* Write/ Edit/ QC final study reports (Full Study Report, Synopsis Study

Report, Abbreviated Study Report, Annual Reports, Narratives) for

regulatory submissions. Therapeutic area - Vaccines of infective

diseases (7 to 9 CSRs, 3 ARs).

* Write/Edit/QC Investigator Brochure, updates of IB.

* Holding regular teleconferences with the team members in the study for

kickoff meetings, review meetings, comments resolution meeting, etc

* Accountable for the quality (Major and minor errors) and timeliness of

deliverables.

* Ensuring all medical writing activities conducted in compliance with

ICH E3 and study specific guidelines.

* Accountable for maintaining culture for high customer service.

* Trainer: Serving as mentor to new hired employees in medical writing

and certified trainer for the project.

* Team Leader:

o Leading a team of 5 medical writers, interacting with other

departments like Quality team (Lean and Six sigma improvements

in process), Audit team, training team, and the like.

o Maintaining dashboard of the team with respect to quality, TAT,

attendance, resource utilization, attrition, challenges, etc

o Responsible for yearly appraisals and quarterly performances of

team members

o Member of Partnership committee with client

* I am also the Business Continuity Plan (BCP) coordinator for our

project and participated in the 3 test runs, intra-city and inter-city

locations.

* I have also faced audit from client (pharmaceutical company) spanning

over 3 days.

Highlight: I have visited a European country for a brief period for on-

site training and initiation of a new project with a leading pharmaceutical

company.

Project Experience for this Company:

* CSR Writing: Phase I to IV trials in immunology, i.e. vaccines.

* Investigator Brochure updates for vaccines.

* Annual Reports

* Team Lead - Management of team and related activities

Employer:-SIRO Clinpharm Pvt. Ltd, Thane, INDIA

Designation:-Medical Writer (March 2007 to Feb 2009)

Key Responsibilities:

* Write/ Edit/ QC final study reports (Full Study Report, Synopsis Study

Report, Abbreviated Study Report, Web Synopsis, Abstracts, Narratives)

for regulatory submissions.

* Write/Edit/QC Investigator Brochure.(25 to 30 various documents in

total)

* Accountable for the quality and timeliness of deliverables.

* Ensuring all medical writing activities conducted in compliance with

ICH E3 and study specific guidelines.

* Accountable for maintaining culture for high customer service.

* Serving as mentor to new hired employees in medical writing.

Special Trainings Undertaken:

* Lean and Six Sigma.

* World Class Customer Care.

* Team Building Workshop.

* Business Etiquettes.

* Manuscript writing.

Project Experience:

* CSR Writing: Phase I, II and III trials in Rheumatoid Arthritis

(Inflammation), HIV, Genitourinary, hormones, CNS, Pain, Psychiatry,

Infection, metabolic disorders, skin, etc.

* Investigator Brochure: New entity for Gingivitis.

* Protocol synopsis

* Comparative studies on Diabetes

Worked for different sponsors with different SOPs and requirements

from US and Europe.

B. MEDICAL TRANSCRIPTION

This basically involves case records of patients dictated by physicians

in US and transcribing them in their exact form for their

hospitals/clinics and insurance purposes. This has given me a fair idea

of the US operations of how their medical system works, their method of

treating and handling patients, their strict medicolegal system, the

hospital way of working, the strict prescription of drugs, etc.

Employer: - CBay Systems India Pvt. Ltd, Mumbai

Designation: - Quality Analyst and Team Leader (March 2004 to Feb 2007)

CBay Systems is based in US and outsources work to about 35 to 40

vendors/units all over India. The job profile consisted of especially

keeping a check on the quality of work done by vendors/units and that the

files are client ready with accuracy of 99% to 100% for all files. Team

Leader activity consisted of leading a team of 6 junior Quality Analysts,

helping and guiding them for new accounts, improving and motivating their

performance in terms of quantity and quality, corresponding with vendors,

sorting out difficulties faced, etc.

Employer: - Spryance India Pvt. Ltd, Mumbai

Designation: - Account Manager and Quality Assurance (July 2003 to Feb 2004

and as Business associate for 3 years)

Spryance has its base in US and is a pioneer in home-based transcription.

Responsibilities included managing accounts in its entirety, in charge

of 2 teams for 2 accounts, each of about 30-40 MTs and 15 to 20 Editors

working from home from all over India. Apart from choosing and inducting

MT/Editor for my particular account, I was also responsible for giving

assistance, training them, and giving feedback on that particular

account. I was working in the company for 8 months in-house and then

from my own residence on contract basis for 3 years.

Employer: - Giltedge Services Pvt. Ltd, Mumbai

Designation: - Medical Transcriptionist (June 2001 to June 2003)

After doing a short course of 4 months in training, I worked at first

as an MT and then senior MT/Editor.

C. GENERAL PRACTICE

General Medical Practitioner (June 2000 to June 2003)

Worked as a Registered Medical Officer in different hospitals (July

1998 to May 2000)

Key Responsibilities:

* Medical management of acute and chronic health problems.

* Also worked with several consultants in Medicine, orthopedics,

pediatrics, ENT, surgery, skin, etc

Skills

* Good knowledge of medical terminology, Biostatistics essential for

medical writing, good interpretation skills

* Proficient knowledge in MS OFFICE (WORD, EXCEL, POWER POINT) and

internet applications

Personal Details

Age: 37 years

Languages proficiency: English, Marathi, Hindi, Gujarati

Hobbies

Cricket, exercising, movies, music

I hereby declare that the above furnished information is true and correct

to the best of my knowledge.

Date: -

Dr. Pankaj Rajput

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