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Online Resumes with "CROS"
Regulatory Affairs Specialist - 16 Years of Experience - Near 19464
An accomplished records and information management specialist with proven skill set including 16 years’ experience within records retention and information management. Focus on health authority audit preparedness, compliance, security, and lifecycle management requirements of key company proprietary media encompassing all GXP documentation. Actively liaise with internal areas and external groups including CMOs and CROs to ...
Tags for this Online Resume: Filing, Management, Quality, Quality Assurance, Quality Control, Retention, Document Management, Documentation, Information Technology, Records and Information Management, Regulatory, Operations, Record Coordinator, Compliance, Regulatory Operations
Pharmaceutical Professional associated with Medical Affairs, clinical research and drug developmentnfro both global and domastic clinical trial management
I have worked for more than 15 years as a project manager in the Clinical pharmaceutical industry for a variety of both large and small companies including CROs. I have been directly responsible for the completion of several large and small global research trials that have contributed significantly to these companies portfolio and intended pipeline for continued product development. Most of my success was directly related t...
Tags for this Online Resume: Clinical Project Manager, PMP trained cetification pending, Medical affairs Clinical operations, All Mocrosoft applications, Global project lead, MBA in BioPharma, Training, Project Management, Project Manager, Research
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
Biologist - 10 Years of Experience
PROFESSIONAL SUMMARY * Highly motivated and versatile scientist with experience in in vitro/cell-based assay development, validation and execution, in vivo pharmacology, including 5+ years of industry experience * Extensive experience in discovery and development of small molecule inhibitors against protein homeostasis * Expertise in defining strategy and providing leadership in various aspects of in vivo POC, target identi...
Tags for this Online Resume: drug discovery, in vitro/cell-based assay development, in vivo pharmacology, RT-PCR/q-PCR, Protein Biochemistry, PD biomarker, CRO expereince, program management, PK/PD relationship, disease animal models, mammalian/primary/cancer/iPS cell culture, co-cultures
Clinical SAS Programming
SUMMARY OF QUALIFICATIONS * Certified SAS/Statistical programmer with over 7 years of experience in data analysis and statistical programming in phases I-IV of clinical trials working for Pharmaceutical companies and CROs in various therapeutic areas with high proficiency and within given timeline * Expertise in analyzing and coordinating clinical trial data, generating reports, tables, listings and graphs using SAS in acco...
Tags for this Online Resume: SAS, Proc, Programming, Data Management, Extensible Markup Language (XML), Generate Reports, HyperText Markup Language, Management, PDF, Pharmaceutical
Clinical SAS Programming
SUMMARY * A Certified SAS Programmer with over six years of working experience in SAS applications for Clinical Research and Analysis. * Experienced working with Pharmaceutical companies and CROs. * In depth experience and knowledge in various SAS products such as BASE /SAS, SAS /MACROS, SAS/STAT, SAS/ACCESS, SAS/SQL in Windows and UNIX environments. * Worked extensively by using base/SAS, SAS/macro, SAS procedures (proc so...
Ideal Companies: Mrs.
Tags for this Online Resume: Cancer, Protocol, SAP, SAS, Oncology, PDF, Proc, Programming, Statistical Analysis, Structured Query Language
Clinical Regional Monitoring
Summary of Qualifications: Over nine years as CRA and ten years as CCRC performing site management of phases I-IV clinical trials with large and mid-sized pharmaceutical sponsors and international CROs: INC Research/inVentiv Health Clinical, Pfizer, United Therapeutics Inc., Clinipace Worldwide (Formerly Paragon Biomedical), GeNO LLC, PAREXEL, Merck, Astra Zeneca/MedImmune, GlaxoSmithKline Actelion, Gilead Sciences, INO The...
Tags for this Online Resume: Management, Pulmonary, Clinical Research, Documentation, Research, Protocol, Allergy, Applications, Assessments, Biomedical Industry
Life Scientist - 20 Years of Experience - Near 19335
Summary An experienced toxicologist with a successful track record supporting drug discovery research and development to progress biologic-based and/or small molecule drug candidate (s) through all phases of nonclinical development (Phase 1-4). Multiple successful NDA approvals, along with BLA approval for a respiratory biologic and successful IND submissions. Extensive and broad based expertise in conceptualizing and desig...
Tags for this Online Resume: Audit, Research, Test, Toxicology, Protocol, Compliance, Training, Evaluate, Medical, Medical Devices, oncology, protocol, pharmaceutical, ich, nonclinical, Regulatory Affairs, Quality Assurance, GXP
Life Scientist - 20 Years of Experience - Near 19335
Summary An experienced toxicologist with a successful track record supporting drug discovery research and development to progress biologic-based and/or small molecule drug candidate (s) through all phases of nonclinical development (Phase 1-4). Multiple successful NDA approvals, along with BLA approval and successful IND submissions. Extensive and broad based expertise in conceptualizing and designing nonclinical developmen...
Tags for this Online Resume: Audit, Research, Test, Toxicology, Protocol, Compliance, Training, Evaluate, Medical, Medical Devices
Chemist
SUMMARY OF QUALIFICATION An accomplished research professional with excellent communication skills who is organized, detail oriented and a team player. Has over 21 years of experience and extensive background that includes leadership role in analytical research in many reputed pharmaceutical organizations. KEY AREA OF EXPERTISE Lead and supervised a team of scientists to execute analytical method development, method validat...
Tags for this Online Resume: DSC, Emerging Markets, High Performance Liquid Chromatography (HPLC), Spectrophotometer, Management, Engineering, Reverse Engineering, Accounting, CFR Part 11, Cost Accounting
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.
