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Online Resumes with "regulatory documents"
Clinical Research
SUMMARY OF EXPERIENCE I have experience in Clinical, in-house CRA as well as Data Management. I have Recruited Private Investigators for Cardiology studies and I have worked with Regulatory Documents. My area of Specialty is coding and In-house CRA. I have coded on Cardiology, Oncology, and Neurological, Antiviral, Respiratory and Diabetic studies. My Computer skills consist of Clintrial version 3.3 and 4.1, Windows 98, Win...
Tags for this Online Resume: Data Manager, Clinical Research, Research, Versioning, Coding, Business Objects, ICD-9, Medical, Medical Terminology, SAS
Clinical Research - 11 Years of Experience - Near 20774
My goal is to successfully coordinate both the technical and administrative details of any research assignment collaborating with the Principal Investigator to achieve study integrity and objectivity through the successful implementation and completion of protocols and procedures. Self-motivated achiever with over eight years' experience in different areas of research work including Human Participants in Research both for C...
Tags for this Online Resume: Clinical Research, Compliance, Good Clinical Practices, Health Care Industry, Health Insurance Portability And Accountability Act, HIPAA compliance, Pharmaceutical, Research, Training
Clinical Pharmacovigilance/Drug Safety - 20 Years of Experience - Near 95117
CAREER SUMMARY * Senior, seasoned pharmaceutical R&D professional with strong administrative, strategic & scientific planning, and coordination/execution skills, gained through 27 years of industrial experience in leading CMC technical development function (Pharmaceutics & Analytical), and leading global development & regulatory filings for NMEs (small molecule and biologics / mAb), and 505 (b) (2) products strong expertise...
Tags for this Online Resume: CMC, Product Development, Regulatory Affairs, Good Manufacturing Practices, Management, Project Management, Technical Lead, DP, Product Development, Supply Chain, Technical Operations
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
Health and Wellness consultant - 10 Years of Experience - Near 89081
Summary * Currently Clinical Research Coordinator. * One-year recruitment specialist for inpatient hospital research studies * 10 months Research Assistant * 13 + years Clinical Research Coordinator * 15 + years Phlebotomist/specimen processor * 5 + years Regulatory Documentation Assistant * 3 + years creating and implementing nursing care plan for diabetes patients * 2 + years hospital and long term care facilities experie...
Tags for this Online Resume: Insulin, Protocol, Clinical Research, Assessments, Centrifuge, Health Insurance Portability And Accountability Act, Inventory, Pulmonary, Documentation, Licensed Nurse
Clinical Regulatory Affairs - 6 Years of Experience - Near 92648
QUALIFICATIONS Document-Labeling Specialist, Nov.2015 - Feb.2016 Well-versed communicator, high organizational and analytical (Contract Position Only) abilities. Work well independently and as a member of a * Creation, Revision of CGL, pre-printed labels and IFU via team. Adept in SUSARs, IRB submissions, Sponsor redlining documents and SOP standards. monitoring, and CTMS files. Efficient at handling multiple regulatory doc...
Tags for this Online Resume: R programming, Word, Excel, Adobe Photoshop, Illustrator, google analytics, github, Adobe, Data Entry, Documentation, ISO
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
Medical or Health Services Manager - 18 Years of Experience - Near 91321
PROFESSIONAL SUMMARY Licensed insurance professional with extensive experience in sales, prospecting and lead generation. Seeks a position offering new challenges and opportunities for career growth and advancement. Accomplished Compliance and Regulatory Affairs Specialist and Insurance Consultant who proudly maintains a highly productive, efficient and quality-driven environment in the ever changing health care regulatory ...
Ideal Companies: DME Supplier
Tags for this Online Resume: Documentation, Policies and Procedures, Services, Sales, Advertising, Compliance, Management, Quality, Regulatory Affairs, Securities
Regulatory Affairs and Compliance Expert
Detailed knowledge of substantial body of regulatory information, including but not limited to OHRP, FDA, HIPPA. Management and training of professional staff with leadership abilities that ensure communication and compliance from all entities. Skilled and well educated in performing audits, needs assessments and use of resources and appropriate resource management. Knowledge and experience with clinical, research report...
Ideal Companies: Research Institutions, Clinical Research
Tags for this Online Resume: Management, Policies and Procedures, Protocol, Research, Leadership, Compliance, Assessments, Health Insurance Portability And Accountability Act, Resource Management, Training
Regulatory Affairs Executive - 10 years Experience - UK
A qualified professional with regulatory expertise and experience gained within the global pharmaceutical, regulatory, hospital pharmacy and clinical research industry. I have experience in the preparation, co-ordination and review of various scientific and regulatory documents for UK, Ireland, European and Eastern European countries. I am a self-motivated and hard working individual with a very flexible and open style, wit...
Tags for this Online Resume: Management, Documentation, Manufacturing, Consulting, Microsoft Internet Explorer, Protocol, Regulatory Affairs, Compliance, MRP, Packaging
Life Scientist - 15 Years of Experience - Near 20782
PROFESSIONAL SUMMARY Exceptional leader talented at building professional relationships, self-motivation and team goals. Technically-savvy with outstanding training and presentation skills. Motivated scientist with solid experience managing all levels of large scale projects, including budgeting and administration. Experienced Scientist professional with strong leadership and relationship-building skills. Meticulous Medical...
Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Manufacturing, Cellular, Documentation, Electrophoresis, ELISA, Therapy, Training
Quality Coordinator - 0 Years of Experience
Summary: * Extensive experience in clinical data management, pharmaceutical, and device research industries. * Experience working with Adverse Event Reporting and Medical Device Reporting. * Strong analytical, problem resolution, and project management skills. * Proficient in monitoring and managing record retention timelines for all clinical and regulatory documents and assistance in the preparation and review of documents...
Tags for this Online Resume: Data Entry, Database, Distribution, Filing, Documentation, Licensing, Medical, Microsoft Access, Regulatory Affairs, Research, clinical research
