Anil Golani
Tel : 91-9833964053
Email :anilgolani@hotmail.co.in
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.
PROFESSIONAL SYNOPSIS
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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).
CORE COMPETENCIES
Scientific Writing & Editing
Team Management
Quality Management
Project Management
Clinical Site Feasibility
Literature search compilation
Strategy Planning
KOL Mapping & Management
Market Identification/Penetration
Medical &Scientific Communication
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 & project specific requirements.
 Interact with client periodically.
 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, research articles summary, slide
decks, disease epidemiology reports, Clinical Study Reports (CSR).
 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.
 Constructed clinical trials trend analysis report and liaised with US team.
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Complete knowledge of writing Manuscripts, ICF and Protocol.
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.
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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.
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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.
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Project Management
Support to manager on study related activities and bid defense.
Liase with clients on any study related issues.
Reviewed project status timely and resolved issues arisen if any.
Coordinated with internal team understanding client requirements.
Proposed solutions and ensured smooth project flow.
Delivered timely results to clients within agreed timelines.
Arranged calls with team and client for any difficulties.
Managed amendment during the project.
Attending meetings as required.
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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.
Data Analysis 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.
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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.
 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
National Institute for Research
in Reproductive Health, Indian Council of Medical Research (ICMR)
Mumbai, India
April 2004 -August 2007
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 patients record and their collected samples enrolled for the study.
 Maintained inventory of study supplies and its documentation.
 Ensure management of clinical supplies in compliance with protocol and overall study 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
 Managed in setting up 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
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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.
ACADEMIC BACKGROUND
2005-2006
Post Graduate Diploma in Clinical Research,
Academy of Clinical Excellence (ACE), Bombay College of Pharmacy, Mumbai, India
1993-1998
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.
AWARDS & CERTIFICATIONS
MAKRO You Shine Award, Best Performer
Good Clinical Practices: National Institute on Drug Abuse (NIDA), NIH, USA
Operating Systems:
Applications:
COMPUTER FORTE
Windows 9X/2000/XP
Microsoft Office (Word, Excel, PowerPoint)
PERSONAL DETAILS
Language skills
Self
Interests
English, Hindi, Sindhi, Marathi
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.
Traveling, Photography, Drawing & Painting
REFERENCES
Available on request
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