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Online Resumes with "investigational brochure "
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 Research - 12 Years of Experience - Near 07086
EXPERIENCE Summary Write and review protocols that are in-line with the indication strategy. Conduct medical review and interpretation of efficacy and safety data from clinical trials. Responsible for the quality, coordination, medical accuracy, and timeliness of clinical study reports, review of Investigator Brochures, CTAs, Safety Data, Clinical Trial reports. Review and provide US feedback to protocols. Work with Clinica...
Tags for this Online Resume: Biopsy, Data Management, Management, Research, Chemotherapy, Clinical Research, Drafting, Process Improvement, Program Manager, Radiation
Medical Scientist - 15 Years of Experience - Near 01775
CAREER SUMMARY I am a physician and research scientist with over 25 years' experience 13 years in Academia and 12 in the Pharmaceutical industry. Prior to my Pharmaceutical journey, I was a Clinician and an Investigator at Boston Univ. School of Medicine, Departments of Surgery, Neurology, and Endocrine & Metabolism where I saw patients, taught, conducted clinical research and also consulted for companies like ATS, Organoge...
Tags for this Online Resume: Publications, Medical, Medical Affairs, Aml (Macro Lang), Therapy, Cancer, Communications, Development Activities, Immunology, Infectious Diseases
Licensed Nurse - 20 Years of Experience - Near 18974
I have extensive experience in writing clinical and regulatory documents in the Pharmaceutical industry which include regulatory and safety I have completed medical encoding (MeDRA), data and quality review management. My past experience included responsibilities for preparing safety sections within key documents such as Investigations Brochure, clinical study reports, writing safety narratives to be included in final stud...
Tags for this Online Resume: Management, Oncology, DS, Query, Medical, Oracle, Oracle Clinical, Database, Encoder, Risk Management
