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Online Resumes with "Clinical study report"

Clinical Research Associate - 5 yearsexperience - Regulator Affairs

I am currently looking for an appropriate job opening in a Research Institute. I have five years experience as a Clinical Research Associate (as Regulatory Officer and Medical Writer). I had been working with reputed pharmaceutical companies in India. I have led a team of Medical writers and as a part of them, I have written Clinical and Pre-clinical overviews on more than 100 molecules for regulatory dossier submission ...

Tags for this Online Resume: Protocol Development, Clinical study report, Clinical study audit and monitoring, Regulatory dossier submission, RMP, PSUR, Leaflet, Regulatory queries

Senior Technical Editor, Electronic Document Coordinator/Specialist

I am MD by background with more than 5 years of clinical research experience

I am looking for a challenging job in a team-oriented environment.

Ideal Companies: Allergan, Genentech, Ista, Santen

Clinical Study Manager

Experienced Clinical Research Professional and Project Manager with over 6 years in managing clinical studies and over 12 years working within Clinical research in the Pharmaceutical industry. Proven ability to manage a clinical trial from start-up through clinical study report and FDA, EMEA approval. Brings strengths of communication, collaboration with other departments and promoting effective teamwork. Known for peer l...

Registered Dietitian, Certified Diabetes Educator

High-powered, compassionate, and versatile healthcare professional equipped with more than 20 years of experience in Clinical Research, Diabetes Education, and Program Coordination. Show competency to manage delivery of clinical study protocols, clinical study reports, study agreements, applications, and other study documentation. Demonstrate strong analysis, research, documentation, and advocacy expertise, coupled with eff...

Statistical Programmer

SAS programming for clinical study reporting, e.g. data and TLG programming; CDISC; PK/PD

Featured Profile

Clinical Research Scientist

I would like to obtain a Clinical Scientist Position in the pharmaceutical industry. I am currently finishing my second year of an industry-based clinical research/drug development fellowship program with United Therapeutics (UT) in collaboration with the University of North Carolina (UNC). My training and experience has primarily been focused on early stage clinical development, particularly in Phase I clinical pharmacolo...

Tags for this Online Resume: clinical scientist, clinical pharmacology, oncology, drug development, clinical trial leader, medical writing

Regulatory Affairs Professional

I'm a clinical regulatory affairs professional with experience in taking medical device products to market in different countries. My experience includes all phases, including study design, budgeting and timeline development, medical writing (e.g., clinical protocol, IND, IDE, etc), clinical study initiation and oversight, data management, premarket notifications (e.g., 510(k), BLA, etc), clinical study reports, and direct ...

Tags for this Online Resume: FDA, ISO, submissions, 510(k), BLA, regulatory strategy, medical writing, management, medical devices

Clinical Research - 20 Years of Experience - Near 19087

PhD Physiologist with 22 years experience participating in and leading clinical matrix teams responsible for innovative pharmaceutical research in gastrointestinal, psychiatric and neurological diseases. Key areas of expertise: phase II and III development planning, clinical study design evaluating novel therapeutic targets, oversight of investigative sites, design and preparation of clinical study reports, NDA summary do...

Tags for this Online Resume: clinical scientist, pharmaceutical, clinical, medical writer

Clinical Research - 20 Years of Experience - Near 33406

• Clinical Research Consultant with over 28 years of Pharmaceutical/Biotech experience including Phase I – III clinical trial development with direct involvement in multiple FDA/ICH submissions leading to six NDA approvals. • Extensive monitoring domestically and internationally, training and mentoring innumerable CRAs/Monitors in the field which lead to further training responsibilities with Study Teams and Management Te...

Tags for this Online Resume: Florida, Pharmaceutical Research, Monitoring, Management, Team Building

Clinical Research - 2 Years of Experience - Near 77449

HIGHLIGHTS OF QUALIFICATIONS: * RN with close to 2-years experience in clinical trials monitoring * Knowledgeable of clinical trial procedures and approval processes. * In-depth knowledge of ICH GCP guidelines and FDA regulations * Conversant with Design and Review of case report forms (CRF) * Conversant with Site Monitoring visits (PSVs, SIVs, IMVs and COVs) to meet study expectations. * Clinical and post-marketing safety ...

Tags for this Online Resume: Direct Patient Care, DRESSING CHANGES, Medical, Patient Care, Suctioning, Surgical, Wound Care, Acquired Immune Deficiency Syndrome (AIDS), HIV, Monitoring