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Online Resumes with "study protocols"
Animal Scientist - 19 Years of Experience - Near 20874
SUMMARY Meticulous and enthusiastic Associate Scientist with extensive experience in GLP compliant contract research organizations specializing in pharmaceutical and drug testing. Strong background in protocol review, study setup, data collection/review and SOP writing/editing. Main ambition and passion is quality care and handling of animal research species. Core strengths and interests include: Writing/following/reviewing...
Tags for this Online Resume: Collection, Audit, Good Laboratory Practices, Instant Messaging, Pharmaceutical, Planning, Process Improvements, Protocol, Quality, Quality Assurance, clinical, protocol, pharmaceutical
Program / Clinical Director/Administrator
Dual diagnosis therapist experienced in working with individuals, couples, and families to provide evaluation, diagnosis and treatment. Strong problem solving and organizational skills, creative and highly motivated. Experienced in program development and clinical leadership. Seeking a high level position in which I can apply my educational, research, teaching, and clinical experience.
Tags for this Online Resume: Emergency Room, Management, Scheduling, Assessments, Therapy, Medical assistant, LMHC, CADC II, DCMHS, Addictions, Dual Diagnosis, Mindfulness-based stress reduction, Trauma, SPSS, Grounded theory, Clinic director, Program director, Private practice, Forensics
Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality
Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...
Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.
Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA
Clinical Research Project Manager Interested in Growing with a Patient Centered Organization
My career goal is to first obtain a clinical research project manager position with an innovative, patient-centered pharmaceutical company, medical device company, clinical research organization (CRO), or medical center. Eventually, I would like to prepare to segue into international development as a Senior Director and play an integral role in developing a research infrastructure for new companies and/or those interested ...
Ideal Companies: Pfizer, AstraZeneca, Becton Dickinson, etc.
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
System Administrator - 0 Years of Experience
Life cycle Management and documentation of specification in Laboratory Information Management Systems (LabWare LIMS) in cGMP environment. * Create and Manage Drug substance, Drug product, and Raw materials specifications in LIMS against the master specification copy available in the Document management system. * Accurately configure Analysis's including Strength, Impurities content, Water content, Content uniformity, Resid...
Tags for this Online Resume: Acceptance Testing, Audit, Configure, Document Management, Documentation, Good Manufacturing Practices, High Performance Liquid Chromatography (HPLC), Management, Manufacturing, Pharmaceutical Industry
Clinical Regional Monitoring - 21 Years of Experience - Near 60031
Over 15 years experience in Clinical Research and Regulatory Study Protocol specifics - ICF's, Inclusion/ Exclusion Criteria, AE/SAE, eCRF's, and SOP Development/Updates * Exceptional attention to detail with strong problem solving skills * Excellent written, verbal and decision making skills * Outstanding interpersonal communication, organization and prioritization skills * Proficient with GCP, ICH guidelines, FDA regulat...
Tags for this Online Resume: Program Manager, Collection, Accenture FOUNDATION, Accounts Payable, Attention to Detail, Billing, Biomedical Industry, Budgeting, Clinical Research, Data Mining
