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Medical Affairs

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Location:
Tobyhanna, Pennsylvania, 18466, United States
Salary:
120000
Posted:
June 07, 2012
Email:
ixrvrx@r.postjobfree.com
Contact Info:
**.*******@*****.***, ***.***.****


SHOURYADEEP SRIVASTAVA
**** ********* ****, *********, ************ 18466
806.***.****
ixrvrx@r.postjobfree.com

~MEDICAL AFFAIRS~

QUALIFICATIONS PROFILE

Highly talented, versatile, and seasoned professional, offering broad-based experience in medical writing, regulatory affairs, clinical drug development, and clinical research, complemented with strong educational foundation. Excel at designing innovative clinical programs/studies simultaneously from inception to completion; powered with a remarkable ability to lead and perform all phases of research. Demonstrate outstanding analysis, documentation, research, and advocacy expertise, coupled with effective writing and presentation skills. Show paramount competency in developing clinical drug while exemplifying in-depth knowledge in a wide variety of medical settings and specialties. Accustomed to working with people of diverse cultures and organizational backgrounds. Detail-oriented with proven capability to multitask in a competitive and challenging environment. Bilingual in English and Hindi. Therapeutic experience includes:

Oncology: Melanoma, Breast Cancer, Colon Cancer| Over-the-counter: Toothpaste, Eye Drops
| Immunology: Rheumatoid Arthritis, Biologics
Infectious Diseases: Otitis Media, UTI, Upper RTI, Herpes | Metabolic: Hypercholesterolemia, Dyslipidemia
Endocrine: Hypothyroidism, Acromegaly | Combination Products: Analgesics, Drug-Device Combinations
Genito-urinary: Urinary Incontinence | Vaccines and Generics | Ophthalmic: Miotic and Mydriatic Agents
Acute and Chronic Pain | New Chemical Entities (NCEs), New Biological Entities (NBEs)

CORE STRENGTHS

- Clinical Research and Analysis
- Clinical Drug Development and Safety
- Leadership, Training, and Team Building
- FDA Drug Applications
- Excellent Presentation and Negotiation Skills
- Industry’s Best Practices and Regulatory Compliance
- Articulate Oral and Written Communication
- Problem Resolution and Decision Making

EDUCATION

DOCTOR OF PHILOSOPHY (PH.D.) IN PHARMACOLOGY AND NEUROSCIENCE: 2010
- Texas Tech University, Health Sciences Center, Lubbock, Texas, USA

DOCTOR OF MEDICINE (M.D.): 2002
- B.R.D. Medical College, Gorakhpur, India

EMPLOYMENT HISTORY

SENIOR MEDICAL WRITER - SANOFI PASTEUR, SWIFTWATER, PA APR 2012–PRESENT

Serve as an integral member of the clinical team responsible for the production of key documents related to Clinical Department and Medical Affairs activities in accordance with the company and external standards, regulatory requirements, and guidelines. Coordinate with medical writers in the preparation of submission documents and the overall development of the submission.

Notable Achievements:
- Played a vital role in managing the vaccine project both throughout United States and Europe
- Entrusted to supervise subcontracted medical writing activities for the project

RESEARCH SCIENTIST II - CAMARGO PHARMACEUTICAL SERVICES, LLC, CINCINNATI, OH MAY 2010–APR 2012

Rendered high level of assistance to clients from earliest assessment through Pre-IND, IND, End-of-Phase 2, NDA, BLA, and ANDA submission, to post-approval dissemination of scientific data. Applied dynamic leadership talents in creating and implementing clinical strategy for drug development. Stayed abreast with current regulatory guidelines toward fulfillment of organization mission and goals. Facilitated training for newly hired research scientists and medical writers to develop their competencies and achieve their maximum level of potential. Recognized as the focal point of contact of clinical staff, pharmacokinetics scientists, quality assurance auditors, CMC staff, and other clinical research scientists. Forged a highly motivated and cohesive organization by displaying exemplary team building and leadership skills.

Notable Achievements:
- Presided over the scientific research writing activities, thus providing full life cycle support from clinical study protocols through regulatory submission
- Organized activities to ensure the delivery of high-quality Pre-IND and End-of-Phase 2 meeting packages; IND, NDA, BLA, and ANDA documents; and other applications to regulatory agencies or clients involved in all phases of drug development programs
- Commended as client’s representative during 5 Pre-IND and 1 End-of-Phase 2 meeting with the FDA
- Entrusted with the writing of clinical and non-clinical sections of IND, NDA, and BLA as well as protocols and CSRs for Clinical Phase 1, Phase 2, and Phase 3 studies
- Authored Investigator Brochures (IBs), Annual Safety Reports (ASRs), Informed Consent Forms (ICFs), Pediatric Waivers/Deferrals, Drug Labeling, and Orphan Drug Requests
- Pivotal in preparing and completing feasibility report for clients–Go/No Go decision
- Initiated the development and implementation of clinical drug development plan
- Performed comprehensive research on market dynamics and disease trend for client drug development program

RESEARCH ASSISTANT - TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER, LUBBOCK, TX AUGUST 2006–MAY 2010

Directed and coordinated day-to-day operational aspects of the laboratory in accordance with university established policies and procedures. Conducted training to junior colleagues and summer interns to attain their highest performance level.

Notable Achievements:
- Received commendation for completing three research projects related to nicotine addiction, pain, and Alzheimer’s disease
- Exemplified keen expertise in publishing three journal articles–1st author publication in the reputed “The Journal of Biological Chemistry (JBC)”
- Highly praised in writing more than 200 pages dissertation including research grants
- Institutionalized and enforced protocol for experiments, achieving outstanding results
- Honored and won numerous scholarships and travel awards
- Appointed as university’s representative at conferences and career fairs

RESIDENT, MEDICAL ONCOLOGY - INDRAPRASTHA APOLLO HOSPITALS, DELHI, INDIA 2005

- Displayed proficiency in diagnosing and treating cancer patients within in/out-patient and emergency settings.

MEDICAL INTERN - DISTRICT HOSPITAL, GORAKHPUR, INDIA 2002–2003

- Gained significant medical experience by working with various departments of Medicine, Psychiatry, Surgery, Pediatrics, OBS-GYN, Community Medicine, Emergency Room; wards; as well as outpatient and specialty clinics.

PROFESSIONAL TRAINING & CERTIFICATIONS

Regulation of Clinical Trials Certification, University of Cincinnati, Cincinnati, OH: 2011
Good Clinical Practice (GCP) Training, Camargo Pharmaceutical Services, LLC, Cincinnati, OH: 2010 and 2011

MAJOR ACHIEVEMENTS

Director, Student Research Week, TTUHSC, USA: 2009–2010
Community Medical School Ambassador Scholarship, TTUHSC, USA: 2009
Team Member, Focus Lubbock–Leadership Program for College Student: 2008–2009
Senator, Student Government Association, TTUHSC, USA: 2008–2009
Vice President, Graduate Student Association, TTUHSC, USA: 2008–2009
Member, Curriculum Committee, GSBS, TTUHSC, USA: 2008–2009

TECHNICAL PROFICIENCY

Microsoft Office Suite: Word, PowerPoint, and Excel | eDOC Documentum Software | eCTD FDA Submissions | Minitab Statistical Software