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Online Resumes with "bla"
Chief Operations Officer - 11 Years of Experience - Near 92122
SUMMARY of QUALIFICATIONS Available for remote project management and San Diego based roles leading business, clinical, compliance structures. Clinical and regulatory catalyst establishing organizational, technological and scientific intelligence, strategies and resources to ensure a profit based business and marketing environment. * Synergistic Scientific and Business acumen, proficient analytical, technical and interpreti...
Tags for this Online Resume: IVD/Medical Device, Pharmaceutical Research, RNA/DNA, Clinical Research, Operations, IND, Regulatory, Project Management, Oncology, AI, cNLP, Genomics
Analyst - 2 Years of Experience - Near 01880
& Provide SAS and other programming support with respect to design, conduct & Analysis of clinical trials. Create SAS analysis databases, summary tables and graphs for presentations, manuscripts and reports. Write and document SAS production macro code that can be used for a wide variety of applications. Develop SAS programs for statistical tables, data listings, and edit checks. Assist with Programming for editing and qual...
Tags for this Online Resume: SAP, Statistics, Protocol, Audit, Credit Card, Equities, IBM MVS Operating system, Job Control Language, Microsoft Windows NT, Public Health, clinical trials
CEO of Quality/Regulatory Affairs- 19 Years of Experience - New York
SUMMARY Senior Executive with combined technical, regulatory strategy, project management and business experience to build businesses and relationships to deliver new products to market. Over 20 years of experience in medical device, pharmaceutical, biologics, and diagnostic development, including In-Vitro Diagnostic, with market leaders such as Johnson & Johnson, Watson Pharmaceuticals and Mela Sciences. Led worldwide regu...
Tags for this Online Resume: Management, Manufacturing, Product Development, Risk Management, Process Engineering, Engineering, Quality, Quality Assurance, Quality Control, Regulatory, Strategy, Clinical Development, Pharmaceutical, Medical Device, Green Belt, PnL
Chemist - 20 Years of Experience - Near 08816
Areas of expertise: * Formulation & Development * Medical Devices and Design Controls * Rx to OTC Switch, NDA, BLA, Device, and OTC Scale-Up and Commercialization * Project and Program Management * New Product Introductions and Commercial Product Support * Clinical Claim Support and Substantiation
Tags for this Online Resume: Advertising, Audit, Business Development, Diagnostics, Document Management, Documentation, Gastrointestinal, Global Support, Litigation, Management
Clinical Regulatory Affairs - 2 Years of Experience - Near 02215
PROFESSIONAL SUMMARY: A Regulatory Project Manager with 2+ years of managing IND/NDA/BLA review processes and 1+ years of cGMPs experience in pharmaceutical industry. Deadline-driven and highly reliable professional, successfully managing over 300 applicants' submissions in IND, NDA, BLA, and BSE as well as participating in 4 cGMPs sponsors' inspections (Japan and Taiwan) and 1 FDA inspection at manufacturing plants. Great ...
Tags for this Online Resume: Compliance, Pharmaceutical, Project Management, Regulatory affairs, CMC, NDA, IND, BLA, cGMP, GCP, ICH
Health Technologist - 7 Years of Experience - Near 02176
Associated Scientist_ Protein formulation and drug product development 2017 - present Shire Provided formulation and process development support for two injectable monoclonal antibody drug product development programs. Designed executed and communicated results of formulation robustness study pH range study PS80 range study. * Executed and communicated results of stability and comparability studies including evaluation of d...
Tags for this Online Resume: Cancer, Manufacturing, Packaging, Product Development, Integrate, Quality, Quality Assurance, Test, Assessments, Pharmaceutical
Senior Medical Scientist
I am a Medical Scientist with extensive clinical development experience and a proven track record of successful contributions to the approval of multiple new drug applications (NDA/BLA). I have a strong foundation of global drug development and extensive experience conducting clinical trials in accordance with local, country-level and global standards. My experiences range evenly from early to late stage clinical developmen...
Tags for this Online Resume: Cancer, Statistical Analysis, Cardiovascular, Chemistry, Diagnostics, Filing, Immunology, Integrate, Management, oncology, trial, pharmaceutical, clinical
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
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
Construction Assistant - 20 Years of Experience - Near 70810
Tags for this Online Resume: Civil Engineering, Endeavor, Engineering, Infrastructure, Insurance, Management, Professional Services, Services, Site Design
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
