CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "NDA"

Quality Control

SUMMARY OF QUALIFICATIONS Quality Systems - Quality Control /Quality Assurance Management of Analytical Laboratories/Quality Audits/Scientific Technical Services Liaison Highly motivated, key contributor in Quality Management and cGMP compliance with more than twenty five years of demonstrated growth and success in scientific applications with Contract Manufacturing Organizations in Quality, R&D and manufacturing. Recognize...

Tags for this Online Resume: Analytical Chemistry, Chemistry, Manufacturing, Research and Development, Commercial Production, Compliance, Packaging, Pharmaceutical, Documentation, Quality, validation, Audits

Chemist - 20 Years of Experience - Near 02467

PROFESSIONAL SUMMARY * A proven leader with a track record of accomplishments with more than fifteen years pharmaceutical industry experience in leading analytical development activities for small molecule drug development * Hands-on experience in analytical project management in drug development and regulatory submissions hands- on experience in analytical method development/validation/transfer in GMP environments expertis...

Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Quantify, Analytical Chemistry, Chemistry, Research, Research and Development, Regulatory Affairs, Applications, CMOS, Development Activities

Programmer - 7 Years of Experience - Near 08807

Experienced with CDISC SDTM (IG 3.1.2 and 3.1.3) and ADaM (IG 1.0) standards. * Created safety, and efficacy SDTM and ADaM datasets, summary tables, listings and graphs (TLFs). * Proficient at using SAS data step and procedures. * Experienced in generating Integrated Summaries of Safety and Efficacy (ISS, ISE). * Validated Analysis datasets and TLFs using parallel programming and other validation techniques. * Created new m...

Tags for this Online Resume: Operating Systems, Pharmaceutical, Pharmaceutical Industry, Proc, Programming, Protocol, Quality, Quality Assurance, Relational Database, SAP, java, it jobs, javascript

Clinical Research - 5 Years of Experience - Near 20720

A Clinical Research Professional position with a pharmaceutical/biotechnology firm or Research Organization where I can utilize my medical and clinical research training and experience along with my strong technical and procedural skills in clinical studies and data management to work as part of a team to reduce the time it takes for a new drug to go from IND through NDA to the market by adherence to GCP and FDA rules and ...

Tags for this Online Resume: phase iii, clinical, phase i, research, pharmaceutical, cro, regulatory, clinical trials, phase ii, phase iv

Senior Medical Scientist

I am a Medical Scientist with extensive clinical development experience and a proven track record of successful contributions to the approval of multiple new drug applications (NDA/BLA). I have a strong foundation of global drug development and extensive experience conducting clinical trials in accordance with local, country-level and global standards. My experiences range evenly from early to late stage clinical developmen...

Tags for this Online Resume: Cancer, Statistical Analysis, Cardiovascular, Chemistry, Diagnostics, Filing, Immunology, Integrate, Management, oncology, trial, pharmaceutical, clinical

System Engineer

Experienced with CDISC SDTM (IG 3.1.2 and 3.1.3) and ADaM (IG 1.0) standards. * Created safety, and efficacy SDTM and ADaM datasets, summary tables, listings and graphs (TLFs). * Proficient at using SAS data step and procedures. * Experienced in generating Integrated Summaries of Safety and Efficacy (ISS, ISE). * Validated Analysis datasets and TLFs using parallel programming and other validation techniques. * Created new m...

Tags for this Online Resume: Active Directory Application Mode (ADAM), Base SAS, C Programming Language, C++ Programming Language, Catalogs, Communication Skills, Compliance, Data Analysis, Data Management, Database

Statistical Programmer - 5 years Experience - US

Summary * Certified Base Programmer for SAS 9 with 5+ years of biostatistical programming experience in CRO, hospitals, pharmaceutical, and healthcare industries. * Involved in drug development process with experience in analyzing, reporting, and reviewing pre-clinical/clinical trial data. * Good understanding of FDA submission (IND, NDA) process, clinical protocols, CRFs, CDISC (SDTM, ADaM), 21 CFR Part 11, GCP, and IRB gu...

Tags for this Online Resume: SAS, Proc, Programming, Statistical Analysis, SAP, Research, Statistics, Structured Query Language, Management, Test

Contract Medical Writer

Summary Work Experience: Strong background in medical writing and biotechnology product and services development, with a solid publication record in the peer-reviewed medical literature in addition to biotechnology analyst articles-an unusual combination of medical writing expertise, analytical skills, data analysis, management experience, and medical knowledge. Participate in pre-clinical, clinical, and commercial research...

Tags for this Online Resume: Business Development, Cancer, Clinical Research, Medical Writer, regulatory science, biologics, drugs, medical device

Biostatatician

Accomplishments * Complete more than 100 studies including phase I to phase IV. * In charge of 20 phase I and 4 phase III study NDA submission tasks to ensure high quality deliverables that comply regulatory electronic submission guidance * Preparation of statistical analysis plans including mock up tables * Application of statistical section of clinical trial reports * Review of protocols/case report forms/statistical anal...

Tags for this Online Resume: SAS, Statistical Analysis, Documentation, Management, Pharmaceutical, Quality, Quality Assurance, Quality Control, Batch Processing, Biomedical Industry

In Between - 5 Years of Experience - Near 500081

Career Summary * SAS Certified Base for SAS9 with more than four years of experience. * Worked on different Phases of clinical trials and I have experience in programming, SDTM, ADAM and reporting in Clinical Research using SAS environments. As a Clinical SAS * Worked on Various Complicated SDTM domains like LB, MO & OE for ophthalmoscopy studies * Understanding of the study Documents and Data (e.g. Study design and objecti...

Tags for this Online Resume: A SERIES, Active Directory Application Mode (ADAM), Base SAS, Cardiology, Clinical Research, Data Management, Documentation, Generate Reports, HyperText Markup Language, Macro (Predefined Code)

Compliance Manager - 20 Years of Experience - Near 78006

CAREER SUMMARY Management professional experienced in a broad range of quality control, quality assurance, regulatory and regulatory compliance functions within the pharmaceutical and medical device industry with over 35 years of experience. * Extensive experience in implementing quality systems to conform to regulatory standards to meet state, federal and international requirements. * Exceptional team leadership, auditing ...

Tags for this Online Resume: Manufacturing, Pharmaceutical, Quality, Quality Assurance, Quality Control, Audit, Diagnostics, API, Application Program Interface, Cardiopulmonary resuscitation (CPR)