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Online Resumes with "NDA"
Global Regulatory Affairs - 14 Years of Experience- New Delhi India 110021
Seeking assignments as a Global Regulatory Affairs Professional - NCEs, GENERICS- Pharma, Biotech products, Botanicals & Medical Devices in Global Regions and/or Quality & Compliance professional across the Pharma & Medical Devices Industry. Overall Profile * With overall 15+ years industrial experience, with 14+ years in the field of Global Regulatory Affairs, Compilation & Submissions of Technical Packages for IND/CTA, ND...
Ideal Companies: BBraun Medical Pvt Ltd, New Delhi, India, Glenmark Pharmaceuticals Ltd., Mumbai, India, Panacea Biotec Ltd., New Delhi, India
Tags for this Online Resume: Regulatory Affairs, Management, Medical Devices, Pharmaceutical Industry, IND/CTA, Formulations & APIs, Regulatory Audits & Compliances, NCEs/NMEs/Generics, CT, Regulatory Consultancy, Regulatory Due Diligence & Gap Assessment
Clinical In-house Monitoring - 6 Years of Experience - Near 07621
SUMMARY OF QUALIFICATIONS Pharmaceutical professional with 5+ years of clinical research experience in management and monitoring. Seeking new and exciting opportunities in new therapeutic areas to expand my expertise. Known for building strong relationships with clients and partnering with management teams to ensure quality services, compliance and efficiency. Manage Clinical Research, third party vendors, and clinical inst...
Tags for this Online Resume: Fraud, ICD-9, Insurance, Medical, Query, Management, Good Clinical Practices, ICH, Documentation, Clinical Research
Clinical Regulatory Affairs - Boston Area
Tags for this Online Resume: IRB, FDA, Clinical Research, Unix, Regulatory Affairs, NDA, GLP
Clinical Research Associate- 3 years Experience
To obtain a position as Clinical Research Associate (CRA) with a pharmaceutical / biotechnology firm where my knowledge and experience along with my strong technical and procedural skills in clinical monitoring can be utilized and challenged to meet the growing needs for clinical trials of new drugs and medical devices in multiple therapeutic areas. Also, to contribute to reducing the time it takes for a new drug to progres...
Clinical Research Associate
SUMMARY: To apply my knowledge of FDA Good Clinical Practice guidelines/ICH guidelines, extensive site/field Clinical Director, Site Lead Study Management, in addition to my experience with various therapeutic areas of medicine, to a position as a Clinical Research Associate. AREAS OF EXPERTISE * Management * Interview candidates and either make a selection decision or recommend individuals for hire. * Able to manage multip...
Tags for this Online Resume: Clinical Research, Research, Accounting, Acquired Immune Deficiency Syndrome (AIDS), Advertising, Amazon Elastic MapReduce, Audit, Basic First Aid, BLS, Budgeting
Quality Assurance Director - 4 Years of Experience - Near 08736
Accomplishments: * Led a group of 6 employees in a 24-person firm * Led a group of employees and consultants to file Icotinib IND to FDA for NSCLC * Directly handled post - IND interactions/questions with FDA * Lined up Accenture to handle eCTD publishing and submissions * Led a group to assemble and file Briefing Packages to UK, Canada, Australia and Singapore Regulatory Authorities set up and presented face-to-face meetin...
Tags for this Online Resume: Regulatory Affairs, Advertising, Business Plan, Filing, Assessments, Business Development, Chemistry, Consulting, Due Diligence, Integrate
Clinical Research - 10 Years of Experience - Near 18901
Summary: * Several years of clinical experience in the industry with excellent knowledge of drug development in different therapeutic areas including oncology, immunology, vaccines, metabolism and biosimilars. Solid clinical practice experience. * Many years of Drug Safety, pharmacovigilance, risk management and epidemiology experience * Experience interfacing with health authorities (worldwide), institutional review boards...
Tags for this Online Resume: Oncology, Protocol, Regulatory Affairs, Risk Assessment, Management, Risk Management, Risk Management Activities, Complaints, Documentation, Hematology, Medical Affairs, Clinical Development
Physician
Profile Experienced, highly motivated healthcare professional with notable accomplishments in clinical and basic research achieved in both academic and pharmaceutical industry arenas. Broad knowledge of all aspects of therapeutic product development. Extensive experience in strategizing and implementing global clinical research and development programs. Known for particular expertise and success in early clinical developmen...
Tags for this Online Resume: Clinical Research, Research, Cardiovascular, Endocrinology/Metabolism and Internal Medicine, Patient Care, Clinical Pharmacology, Protocol design/ Medical Monitoring, Budget Review, Budgeting, Board Certified/ Internal Medicine, Subspecialty-Endocrinology/Metabolism, Pharma/Clinical Research - Phase 1,2,3, Pennsylvania/ Pfizer (formerly Wyeth), Phase 1 and 2
Clinical Quality Assurance
SUMMARY OF QUALIFICAITONS * Global and domestic cGxP operation, quality and packaging experience in medical/precision and diagnostic devices, pharmaceuticals and biomedical industries * Managed Chemistry and Manufacturing Controls: including API sourcing, vender/raw material qualification, formulation, product/process development, scale-up, clinical supplies, technology transfer and validation * Wrote and compiled CMC porti...
Tags for this Online Resume: Cancer, Consumer Products, Engineering, OTC, Process Engineering, Product Development, Risk Analysis, Commercial Production, Team Lead, API
Procurement clerk
Summary: Positions held as Procurement Manager, Procurement Specialist, Contract Administrator, Contract Specialist, Subcontract Administrator, and Buyer. Thorough knowledge in receiving requisitions, preparing the CDRL's for RFP's, RFQ's, RFB's, IFB's, to create and issue solicitations to direct/indirect industry vendors to award Master Agreements, Long Term Agreements, preparing pre-award survey for award of Supply, and S...
Tags for this Online Resume: Solicitations, Buying, Prime Contracts, Contract Administration, Procurement, Procurement, Inventory, MRP, Management, Supply Chain, Purchasing
Business Analyst - 10 Years of Experience - Near 92008
A career integrating my professional technical background with innovative company solutions in Product Management (Product Owner), System Engineering, or a Software Development field. Product Manager (Product Owner) Experience Highlights * Met with customers to identify product requirements and confirm design plans meet customer expectation. Beta test major product releases * Migrate legacy Development teams from Waterfall ...
Tags for this Online Resume: Product Owner, Architect, Scrum, Agile, Management, Process Management, Sales, Sales Engineer, Support, Technical Support
Contract Medical Writer - 10 Years of Experience
Biomedical Ph.D. from Duke University with almost 10 years of diverse medical writing (regulatory and publications) and pharmaceutical industry experience supporting multiple phase I, II, and III trials. Seeking contract medical writing roles in a pharma/biotech setting.
Tags for this Online Resume: Clinical Study Reports, Medical Writer, Pharmaceutical, clinical trial, CTD/NDA, protocol, regulatory, publications
