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Online Resumes with "Drug Development Process"



Medical Scientist - 2 Years of Experience - Near 55369

Summary of Key Qualifications I am a highly motivated, independent scientist with a wide range of scientific and clinical interests. I can offer: (1) experience in industrial collaboration and working with key stakeholders in academia and industry, (2) an understanding of the drug development process and FDA regulations for MSLs, (3) 10+ years of scientific training, with flexibility across different therapeutic areas (e.g....

Tags for this Online Resume: MSL, Medical Science Liaison, Medical Affairs, KOL, Biotech, Pharmaceutical, Communication, Teaching, Networking, Project Management, Independent, Cell Biology, Oncology, Neurology, Cardiology, Gastroenterology, Endocrinology, Northwest, California, Midwest, United States, Northeast, Field, Travel, FDA, off-label, business acumen

Marketing - Near 94401

Summary of Qualifications Seeking a position in Medical Affairs/Medical Writing/Regulatory Affairs/Marketing/Publications: * Pharmaceutical, Medical Device, Biotech and High Tech industry management experience and training * Expertise in translating complex technical, scientific and medical information into internal and global customer communications strong client communication skills Experienced with literature reviews, se...

Tags for this Online Resume: Advertising, Management, Project Management, Statistical Analysis, Telemarketing, Billing, Budgeting, Certificate Authority, CMM (Capability Maturity Model), Coding

Clinical Research - 1 Years of Experience - Near 07011

As Clinical Trails Associate and e-TMF expert, I have a solid expertise in the New Drug development process as well as a strong document management skills and experience with essential regulatory documents detail oriented, organized, quality driven and able to work in a team environment both national and international.

Tags for this Online Resume: Management, Data Queries, Metadata, CTMS- TMF

Clinical Pharmacovigilance/Drug Safety - 10 Years of Experience - Near 19440

Summary Clinical Scientist/Clinical Data Analyst/Clinical Data Management/Project Coordinator/GLP auditor/Research Biologist with over 15 years experience in the pharmaceutical industry. Authored/QC review of protocols, protocol amendments, protocol clarification letters, informed consent forms, risk language, periodic safety reports (PSUR, DSUR, QSR), investigator brochures, medical monitoring plans, clinical SAE narrative...

Tags for this Online Resume: Protocol, Oncology, Audit, Monitoring, Critical Care - Neurology, ICH, Neurology, Quality Assurance, Test, Data Quality

Clinical Regional Monitoring - 17 Years of Experience - Near 46321

SUMMARY OF CLINICAL EXPERIENCE Eleven years' experience as a CRA which includes 2 years as a Lead CRA in clinical trial monitoring, including study start up, study initiation through closeout, as well experience in International, and Domestic studies. Provide on-site clinical trial monitoring and full site management at investigational sites in the conduct of Phase II-IV clinical trials. Recruited and trained CRA (s), inves...

Tags for this Online Resume: Data Management, Gastroenterology, Management, Patient Education, Pharmaceutical Industry, Start up, Clinical Research, Research

Programmer Analyst - 10 Years of Experience - Near 21044

SUMMARY * Certified Clinical SAS Programmer with years of experience in SAS Base/Advance with extensive knowledge in drug development process and clinical trials. * Extensively working on various therapeutic areas like Oncology, Dermatology, InfectiouDiseases, Respiratory, Copd, Immunology, Cardiovascular and Nuerology. * Extensively working on clinical trial projects (Phase I, II and III) with Bio-Statisticians, Data manag...

Tags for this Online Resume: Statistical Analysis, HyperText Markup Language, Proc, VITAL SIGNS, SAS, Macro (Predefined Code), Oracle, Oracle Clinical, PDF, Protocol, sql, html

Medical or Health Services Manager - 2 Years of Experience - Near 27587

PROFILE_______________________________________________________________________ * Seventeen months of experience working in a clinical environment and preventive medicine and also nearly two years of experience in public health and medical research * Possess excellent communication and presentation skills, and the ability to interact confidently with all level of professionals. * Self-motivated with strong analytical thinkin...

Tags for this Online Resume: Emergency Room, ER, Management, Medical, Orthopedic, Orthopedics, Apple MacIntosh, Cardiopulmonary resuscitation (CPR), Consulting, Data Extraction, healthcare research

Clinical Research - 9 Years of Experience - Near 1

Liliana Andrea Sánchez Valencia is a Clinical Research Associate Sr. CRA at Inventiv Health Clinical Colombia S.A.S, based in Bogotá Colombia, where she completes project activities associated with monitoring functions of Phase I-IV clinical research studies while continuing to develop knowledge of the drug development process, Good Clinical Practices, and relevant regulations. Ms. Sánchez has therapeutic experience in the ...

Tags for this Online Resume: Clinical Research, Management, Research, Protocol, Query, Project Management, Project Manager, Documentation

Clinical Research - 9 Years of Experience - Near 45999

- 3 clinical research studies while developing an understanding of the drug development process Good Clinical Practices and relevant regulations. Perform management of study site activities to ensure the integrity of clinical data in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs). New experience oncology trials (lung cancer melanoma antigen-specific immune-therapeutics) RDE (elect...

Tags for this Online Resume: Clinical Research, Research, Oncology, Overdose, Cord Injury, SAP MM module, Application Support, Good Clinical Practices, Management, Support

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

Programmer Analyst

SUMMARY * 6 years of experience as a Statistical Programmer in Clinical trials of Pharma Industry. * Expertise in SAS programming features like BASE SAS, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/SQL, and ODS. * Skilled in generating reports featuring various SAS procedures, like Proc Report, Proc Summary, Proc Freq, Proc Mean, Proc Transpose, Proc sort, Proc Univariate, Proc Datasets, Proc Compare, Prco SGPLOT, and Proc SQL. * ...

Tags for this Online Resume: Base SAS, Macro (Predefined Code), Proc, SAS, SAS/STAT, Statistical Analysis, Structured Query Language, Data Analysis, HyperText Markup Language, Microsoft Excel

Admissions Director - 0 Years of Experience

SUMMARY * Pharmacovigilance Associate with over 2+ years of experience in Drug Safety and Clinical practice fields with clear understanding of EDC (Electronic Data Capture) * Experience in performing successful data management, triage, case entry, MedDRA, WHOdrug dictionaries, narrative writing, peer review, case follow-up, case review and report preparation * Performing Data entry and Quality check adverse event reports fr...

Tags for this Online Resume: Quality, General Practice, HYGIENE, Medical, Surgical, Acceptance Testing, Assessments, Business Intelligence, Coding, Database, healthcare