Senior Scientist Resume Profile, NJ - Hire IT People

SUMMARY:

Nine years experience in clinical practice as Internal Medicine physician, twelve years of solid experience in pharmaceutical company as clinician principle clinical research scientist
Physician with in-depth knowledge of therapeutic areas of Endocrinology, Oncology, Gastroenterology, Cardiovascular, Infectious disease, Respiratory and Nephrology,
Comprehensive knowledge of international drug safety and pharmacovigilance principles and regulations
Excellent language skills in both English and Chinese fluent in verbal and written ,
Strong leadership, excellent written and oral communication skills, and project management skills.
A highly dedicated professional with extensive knowledge and experiences to initiate, coordinate, and complete projects in a timely and cost-effective manner,
Demonstrated leadership, analytical, problem solving and time management skills,

PROFESSIONAL EXPERIENCE:

Confidential

Senior Scientist

Design, execute, and interpret clinical study. Write clinical study-related documents e.g., clinical study synopses and protocols, clinical study reports, investigator brochures, informed consent form, clinical study data and regulatory agency submission. Develop and support Clinical Development Plan for specified projects, study reports, SOPs and method transfers. Manage AEs and SAEs to determine the further action. Answer safety questions and review the literature as needed to address safety issues. Perform medical review and review all patient narratives. Comply with applicable GLP, GCP and safety regulations. Perform and report the necessary documentation to support regulatory filings such as IND and NDAs. Prepare development proposals, execute protocols, and generate technical reports and regulatory submission documents. Make significant contribution to support development and approval of products such as Diovan , Exforge , Gilenya , Afinitor and Gleevec .

Confidential

Associate Scientist

Reviewed statistical analysis plans and clinical study data, and interpreted and summarized clinical study results. Conducted trouble shooting and problem solving in drug development. Searched published scientific information and treatment guidelines for a variety of therapeutic areas. Developed and maintained strong relationships with non-clinical study scientists and clinical research scientists. Participated in study related meetings, maintain and disseminate meeting minutes internally. Discussed clinical study protocol and drug profile at site initiation meetings. Participated in safety update/dose escalation meetings and maintained meeting minutes. Authored protocols, reports, publications and presentations for projects and related studies. Made significant contribution to Levosimendan and its metabolites, and submissions of Xinley and Kaletra products.

Confidential

Research Assistant

Performed research studies in free radical and radiation biology with molecular and cellular biological techniques. Major areas of research included biological mechanisms of anticancer therapy, as well as the mechanisms of normal tissue damage during cancer therapy.

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Senior Scientist Resume Profile

NJ

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