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Online Resumes with "new drug application"
Art Director, Packaging Labeling Specialist
Experienced Product Labeling, Package Specialist; partnering with Package Engineering, Marketing, Legal, and Regulatory Groups to design, create and prepare high quality product Labeling used in Pharmaceutical Packaging. Create and Control use of labeling masters; approve implementation of all labeling and project schedules to meet deadlines for product launches, New Drug Application submissions, and Marketing presenta...
Tags for this Online Resume: Pharmaceutical, Product Labeling, Art Director, Packaging, Regulatory Labeling
Director of Life Sciences Consulting
Lead a Life Sciences Practice and ultimately progress to the VP level.
Ideal Companies: Business and IT consulting firms in life sciences;professional services firms in life sciences.
Tags for this Online Resume: Program Director, Process Optimization, Systems Integration, Human Performance Optimization, Application Design & Development, Leadership, Research and Development, Clinical Research, Clinical Research and Development, Regulatory Affairs, Safety Surveillance, Marketing and Advertising, R and D
SCIENTIFIC WRITER / PROJECT MANAGER / CONSULTANT
Having contributed to the success of major organizations by orchestrating expert alignment of scientific and business management resources with enterprise objectives, I am now seeking to join a company such as yours in the role of scientific writer. With more than 20 years of combined experience providing advanced leadership, delivering top level research and product development, and driving strategic analysis and planning...
Validation Consultant/Quality Engineer/QA Mgmt - Biopharmaceuticals/Medical Devices
Seeking Validation/QE/QA Mgmt positions in the Wilson/Raleigh/Greenville NC area.
Ideal Companies: Purdue Pharma, Becton Dickinson, Sandoz, Merck, GSK, Novo Nordisk, Grifols, DSM
Tags for this Online Resume: Validation, QA, SQ, Regulatory, QE, CAPA
Sr. Director/Director Clinical Quality Assurance and Compliance
Over 19 years of Regulatory / Clinical Quality Assurance & Compliance / Auditing experience. Maintain an excellent knowledge base of all applicable Guidelines, FDA Regulations as well as best practices. I have prior interaction with the FDA, and EMEA/MHRA authorities, leading to successful outcomes. I am considered to be a strategic leader and planner effective in a team environment and customer service focused, with exc...
Tags for this Online Resume: Clinical Quality Assurance, Compliance, Auditor, GCP, Quality Systems, Director
Certified Clinical Data Manager - 10 years Experience - Kansas City
Seeking managerial position in clinical trials industry. Utilize skill set developed during experience and through certification. 1 of 600 worldwide CCDM's.
Tags for this Online Resume: Kansas City, CCDM, clinical trials, telecomute, new drug application, oncology
Energetic, results-oriented individual with established credibility and respect at FDA and EMA. An extraordinary record which includes the lead and approval on New Drug Applications (NDA) and Marketing Authorization Application (MAA)
Global Regulatory Affairs leader for a combination of RA functions. Provides clear and specific regulatory input using skills(scientist, regulator and lawyer) to provide strategic planning decisions and implementation enabling successful drug approvals. Strong leader, expertise in DD, alignment with business goals, creative, proficient with complex frameworks and integration of abstract concepts in clinical and CMC areas o...
Tags for this Online Resume: Regulatory Affairs, small molecules, CDER, CBER, FDA, EMEA, IND, NDA, CTA, IMPD, proteins, anti-infectives, cardiovascular, pain, oncology, CMC, compliance, communicator, monoclonal antibodies , Biologics, Food and Drug, Global, eCTD, health authorities, alliance management, combination products, Biologics Biosimilars , Director , pharmaceutical , Leadership, Problem solving , Innovation, experienced, IND NDA CTA MAA, business goals , biologics - pharmaceutical , biosimilars
sales representative, foreign trained medical doctor, US citizen
I am a physician with over 14 years experience in clinical medicine, staffing and administration. I also hold a BA in chemistry with over 14 years experience in bench chemistry, research and development, CGMP, OSHA regulations and FDA filing protocol of ANDAs (Abbreviated New Drug applications). I cannot wait to be employed in sales by a pharmaceutical company where I will work with the team to enhance the company's goals a...
Chemist - 20 Years of Experience - Near 21060
Laboratory Supervisor successful in leading method development, validation, stability and transfer activities for complex pharmaceutical dosage forms for Abbreviated New Drug Applications (ANDA). Extensive experience in GMP, GLP and DEA compliance. Highly skilled in HPLC and GC analysis including expertise with Empower software. Recognized as a leader with excellent interpersonal communication skills, who excels in organiz...
Tags for this Online Resume: GMP/GDP/GLP, FDA, SOP, Project Management, Mid-Atlantic
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
Production Manager - 20 Years of Experience - Near 32825
PROFILE A strategic results-driven Quality / Validation, Operations, Engineering, and Project Management Professional with more than 15 years of experience in world class Pharmaceuticals and Medical Device industries. Vast experience compliance of cGMPs and associated regulations, investigations and corrective actions (NC & CAPA), remediation's planning/budgeting and execution of commitments to FDA, equipment and facilities...
Tags for this Online Resume: Quality Assurance, Budgeting, Complaints, Compliance, Consulting, Corrective Actions, CVS, Distribution, Engineering, Management
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
