Anil Golani

Tel : 91-983*******

Email :acfo8q@r.postjobfree.com

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A competent professional with significant functional experience in the

sphere of Pharmaceutical/Clinical Research and striving to be a key player

in achieving organizational objectives by utilizing domain knowledge.

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PROFESSIONAL SYNOPSIS

< More than 8 years of experience inclusive of Basic & Clinical Research

and Marketing.

< 7 years experience in Clinical Research that includes Scientific

Writing, Site Feasibility, Patient Recruitment & Retention.

< Developed Epidemiology Reports, White Papers, Articles, Abstracts and

other clinical write ups.

< Knowledge of writing Clinical Study Reports (CSR), Manuscripts, ICF

and Protocol Development.

< International Publications- Co-Published in British Journal of

Clinical Pharmacology, 2008;

Molecular Diagnosis and Therapy, 2009.

< Co-Authored poster presentations in National & International

Conferences.

< Laboratory Research experience in Infectious disease (Tuberculosis).

< Quality driven, Self motivated, Enthusiastic, team player with strong

determination and management skills.

< Organized, detail oriented & ability to rapidly learn and innovate in

new areas.

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CORE COMPETENCIES

Scientific Writing & Editing

Literature search compilation

Team Management Strategy Planning

Quality Management KOL Mapping & Management

Project Management Market

Identification/Penetration

Clinical Site Feasibility Medical &Scientific

Communication

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CAREER FEATURES

Medical Specialist

January 2014 - Present

Medulla Communications Pvt. Ltd

Mumbai, India

Role:

< Conducting literature search for developing medical communication.

< Developing medical communications for leading Pharmaceutical & FMCG

Healthcare companies.

< Preparing newsletters, visual aids, communication for sales force,

slide decks, healthcare pages on social media.

< Understanding client's medico-marketing requirements.

< Coordinating with internal client servicing team recommending medical

content solutions fitting client's requirements.

Sr.Clinical Research Scientist

August 2010 - December 2013

MakroCare Clinical Research Ltd.

Hyderabad, India

Role:

Scientific Writing

< Review of literatures from various sources including PubMed,

publications, etc.

< Developed scientific materials: white papers, articles, abstracts for

scientific conferences, research articles summary, slide decks,

disease epidemiology reports.

< Developed disease specific clinical write ups for bid defense purpose.

< Prepared country reports covering healthcare system, regulatory,

ethics, and market authorization.

< Developed web content material for company website.

< Prepared patient narratives as and when specified.

< Knowledge of writing Clinical Study Reports (CSR), Manuscripts, ICF

and Protocol.

< Constructed clinical trials trend analysis report and liaised with US

team.

< Interacted with clinical development team and improvised content.

< Provided timely & accurate scientific data to internal & external

customers.

< Coordinated with clients in understanding their requirements.

< Ensured deliverables met project specifications, quality and

timelines.

< Trained junior writers for their writing activities.

< Supported colleagues in non-clinical activities and set up initiatives

like metrics tracking, knowledge sharing, training, etc.

< Independently wrote most of writing assignments with minimal guidance

from senior staff.

< Responsible for preparation of assigned documents to high standard as

per company's SOP and client requirements.

Feasibility/Site Start up

< Developed site feasibility questionnaire as per protocol requirement

< Studied pre-feasibility information on incoming protocols/projects.

< Clinical site travel to assess feasibility and site level

requirements.

< Interacted with PI's for any protocol queries/suggestions.

< Site liasoning & development, assisted business analytics division for

budget preparation.

< Assisted in designing patient recruitment strategies on incoming

feasibility as per country requirement.

< Attended clinical project meetings, clinical training sessions as per

project communication, monitoring and / or training plans.

< Training to site personnel when required.

< Provided assistance to study team for preparation of study start-up

materials.

< Supported in preparation and conduct of investigator meetings.

< Prepared site visit report as per SOP/sponsor requirements.

< Assisted, coaching and mentoring of junior team members.

< Submission of CTA, follow-ups and query resolution.

< Supported in development of ongoing review of organization SOP's.

< Active participation in interdepartmental meetings and trainings.

Business Development

< Assisted business development and marketing teams in regards to

clinical site management activities.

< Supported in pre-sales activity by contributing inputs to incoming

RFIs, RFPs.

< Supported in business meetings by contributing domain expertise.

Miscellaneous

< Maintained GCP Helpdesk website & troubleshooted received questions on

GCP from time to time.

< Developed current and comprehensive medical information database on

different therapeutic areas.

< Analyzed data for Phase II and III trials in South East Asia.

< Key team member in developing regulatory intelligence tool for company

use.

< Provided inputs in development of training modules, metrics tracking,

and its periodic up gradation.

< Maintained clinical trial documents in appropriate study files.

< Attended seminars and conferences periodically.

< Assisted in internal and ISO audit preparations.

Project

Title: KOL Mapping and Identification

Designation: Team Lead

Role:

< Identified KOL's in Neurology, Pulmonology, ENT, Dermatology, and

Pediatrics.

< Mapping of OL's & KOL's on basis of competitive Intelligence metrics.

< Guided other team members on data collection strategies.

< Supervised team performance from time to time.

< Coordinated with internal team understanding client requirements.

< Projected study deliverables to PMO team as needed.

< Resolved issues arisen if any.

< Ensured smooth project flow.

White Papers developed:

< Cancer in Emerging Markets of the world

< Patient Recruitment & Retention Oncology trials-

Challenges & Best Practices

< Patient Recruitment & Retention CNS trials-Challenges &

Best Practices

< Patient Recruitment & Retention Pediatric studies-

Challenges & Best Practices

< Oncology Trials in Emerging regions-A trend analysis

< CNS Trials in Emerging regions-A trend analysis

< Feasibility & Site Optimization in Oncology clinical

trial

< Post Marketing Clinical Follow up

< Regulatory Environment & Clinical Trials - South East

Asia

< Epidemiology report on Non-Small Cell Lung Cancer in Asia

< Epidemiology report on Breast Cancer - Global

Perspective.

Accomplishments:

Scientific deliverables created were well liked and

appreciated by target audience.

Research Executive - Medical

August 2009- July 2010

ADI Back Office Professionals Pvt. Ltd.

Mohali, India

Role:

< Gathering requisite information by literature search for drugs,

medical devices using web,

and published materials.

< Maintained database of collected information.

< Data Analysis using excel and making a comparative.

< Preparation of detailed report as per client requirement.

< Training of other team members

< Other duties as and when assigned by manager.

Laboratory Technician

April 2004 -August 2007

National Institute for Research

in Reproductive Health, Indian Council of Medical Research (ICMR)

Mumbai, India

Project

Title: To Study transfer potential of Isoniazid from circulation to

breast milk in lactating women on chronic

therapy for tuberculosis and studying of genetic polymorphisms

associated with it.

Role:

Clinical Research

< Assisted in conducting site selection, site development and

close-out endeavors.

< Assisted in recruiting potential subjects by validating

inclusion/exclusion criteria.

< Assisted in developing ICF and Protocol as per study

requirement.

< Explained subjects about the study procedure.

< Reviewed ICF and facilitate translation into local languages.

< Facilitated meeting arrangement with Ethics committee.

< Maintained a record of patients enrolled for the study and

their collected samples.

< Maintained inventory of study supplies and its documentation.

< Ensure management of clinical supplies in compliance with

protocol and overall clinical objectives.

< Stored samples from study site to the laboratory for further

analytical research.

Laboratory Research

< Assisted in analyzing study procedure by reviewing literatures.

< Standardized HPLC for determination of anti-tuberculosis drug -

Isoniazid.

< HPLC analysis of patient samples and data recording for

analysis.

< Assisted in data analysis using appropriate statistical tests.

< Helped in carrying out detection of NAT2 polymorphism using PCR

and RFLP techniques.

< Conducted gel electrophoresis of PCR samples, observation and

interpretation of results.

< Collected tissue samples for RNA/DNA extraction from

commercially available kits.

Miscellaneous

< Key member in setting of new laboratory.

< Maintained record of laboratory supplies.

< Coordinating with internal staff for management and receipt of

study materials.

Accomplishments:

Co-Published in a International Journal- (1) "British Journal of

Clinical Pharmacology" in 2008

(2)

"Molecular Diagnosis and Therapy" in 2009

Data Executive

February 2002-March 2004

Battaerd Mansley Pvt. Ltd. - subsidiary of IMS Health Australia

Mumbai, India

Role:

< Collated and entered medical data obtained from various

hospitals and dispensaries.

< Reviewed entered data for any discrepancies.

< Performed quality checks by use of medical dictionaries and

other medical software's available.

< Coded the data through proper coding procedure provided.

< Analyzed and managed the quality of the data.

< Weekly meeting with team members on the improvement of the

service line.

< Maintained the weekly report & reported to manager for any

enhancement required.

Medical Representative

October 1999-December 2001

Doshi Hospicare,

Mumbai, India

Role:

< Promoted pharmaceuticals to Physicians.

< Periodic meeting with chemists & druggists.

< Resolved issues involving product availability and quality service.

< Increased business demand, regular discussions about new product

requirements with dealers & sales team.

< Conducted field sales analysis to determine status of account

activity.

< Carried out market research and customer surveys to assess demand,

brand positioning and awareness.

< Identified and promoted the introduction of new products to identify

high-end/low-end markets.

< Created promotional marketing strategies to boost sales through off

side tent sales events.

< Managed budget analysis for products and maintained check on

inventory.

Accomplishments:

< Increased product line sales and managed company's accessories.

< Played an integral role in the company's on-going success as a

product distribution leader.

Project Officer

August 1999-September 1999

WHO project-"Rational use of Drugs"

Seth G.S. Medical College & Hospital.

Mumbai, India

Role:

< Visited hospitals, met doctors, patients discussing medicines

assigned for existing medical condition.

< Checked medicines given and explained regarding about its

proper usage.

< Counseled patients for safe and effective use of medicines.

< Maintained daily report of patient's number, health conditions

and drugs assigned.

< Discussed with doctors about alternate drug suggested for the

particular health status.

< Collected appropriate data regarding current health issues.

< Coordinated with team members analyzing the data collected &

reporting to manager.

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ACADEMIC BACKGROUND

1 Post Graduate Diploma in Clinical Research,

Academy of Clinical Excellence (ACE), Bombay College of

Pharmacy, Mumbai, India

1998. Bachelors in Pharmaceutical Sciences.

Principal K. M. Kundnani College of

Pharmacy, University Mumbai, Mumbai, India.

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POSTERS & PUBLICATIONS

Publications

1. Singh N, Dubey S, Chinnaraj, S, Golani A, Maitra A. Association with

Plasma Isoniazid concentration

in a cohort of tuberculosis patients. Molecular Diagnosis and Therapy

13 (1), 49-58, 2009.

2. Singh N, Golani A, Patel Z, Maitra A. Transfer of Isoniazid from

circulation to breast milk in lactating women on chronic therapy for

tuberculosis. British Journal of Clinical Pharmacology 65 (3), 418-

422, 2008.

Poster presentations

1. N.Singh, A. Golani, J.Kanojia, S. Babu, C. Saravanan, A. K. Roygaga,

V. Salvi,

Z. Patel and A.Maitra- "Association of NAT2 Genotype with Transfer

Pattern of Isoniazid from circulation to Breast Milk in Lactating

Women on Therapy" in a International Symposium on Emerging Trends in

Genomic and Proteomic Sciences, 2006, Mumbai, India.

2. A. Golani, C.Sarkar-"Intellectual Property Rights and Drug Discovery

Regime" in a National conference- Environmental Technology: Biological

Perspectives Issues and Challenges, 2006, University of Mumbai.

3. N. Singh, Z.Patel, V. Salvi, A. Golani, J.Kanojia and A. Maitra-

"Genotyping of NAT2 polymorphism in a randomly selected Indian

population: It's association with Isoniazid metabolism" in a

International Symposium on Human Genomics and Public Health and 31st

Annual conference of ISHG, 2006, National Centre of Applied Human

Genetics, School of Life Sciences, JNU, New Delhi.

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AWARDS & CERTIFICATIONS

MAKRO You Shine Award, Best Performer

Good Clinical Practices: National Institute on Drug Abuse (NIDA), NIH, USA

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COMPUTER FORTE

Operating Systems: Windows 9X/2000/XP

Applications: Microsoft Office (Word, Excel,

PowerPoint)

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PERSONAL DETAILS

Language skills English, Hindi, Sindhi, Marathi

Self Like to take challenges; strive

consistently to achieve personal & professional goals

Excellent communication, presentation

and interpersonal Skills.

Ability to take up responsibilities

and deliver timely results.

Ability to cope under stressful and

difficult conditions.

Highly achievement oriented with a

positive attitude.

Interests Traveling, Photography, Drawing & Painting

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REFERENCES

Available on request

Contact this candidate