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Online Resumes with "CTD"
Clinical Pharmacologist (PhD)
A Study Co-ordinator (PhD in Pharmacology) with more than 2.0 year of experience in the pharmaceutical industry. Demonstrated ability to attain and maintain a working knowledge of GCP, schedule Y (Indian CDSCO guidelines), Clinical Trial Document (CTD), and applicable SOPs. Expertise in BA/BE studies, managing clinical trials data, formulating source documents and data collection charts and severe adverse event reporting. C...
Tags for this Online Resume:
Clinical Pharmacologist, ClinicalPhamacokinetics, Clinical PK-PD, BABE studies, Phase III studies
Regulatory Summer Intern in New York
I Am Student in Long island university in New York. I will be graduating in May 2014. i am looking out for entry level jobs in Regulatory Affairs/ QA/ Drug Safety
Tags for this Online Resume:
SPL( Pharma Ready), module 2 and 3, SPSS, QSS and QSP, labelling, ANDA and e CTD
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
Mexico
Able to expedite the documents required by Latin America BoH. Knowledge of the different sections (CTD) that have direct impact on the product. Knowledge of Latin America regulations relative to pharmaceutical and nutritional products. Capable of preparing documents for registration, variations and product renewals.. Knowledge of Good Documentation Practices. Able to expedite legal documents that make up a dossier. Evaluati...
Director Regulatory Operations, Princeton, NJ
I am a regulatory affairs operations and publishing professional who has over 16 years experience in the publishing and management of Regulatory submissions. Expertise in the eCTD submission format for IND,NDA and MAA.
Tags for this Online Resume:
ectd, regulatory, submissions, publishing, electronic applications, validation
Senior Life Scientist - 16 years Experience - Biotechnology - Colorado
A committed and highly accomplished biotechnology expert with 16 years of research and development experience, leading and supervising teams and managing a wide range of drug development projects for small biotechnology companies. Possesses knowledge and experience of pulmonary, cardiovascular, gastro-intestinal, and other disease indications and models. Vital skills and hands-on experience include science writing excellenc...
Tags for this Online Resume:
Research and development, Writer, Communications, Science, Drug development, Supervisory, Biotechnology, Pharmaceuticals, Reports, Research, Team Leader, Project Management, Animal Models, IND, eCTD, Strategy, Recruiting, Drug Efficacy, Team, Management, Pulmonary, Gastrointestinal
Document Specialist - 20 years experience - Philadelphia
Tags for this Online Resume:
eCTD, IND, submission readiness, NDA, Document management , ICH, FDA, EMEA, SOP
Sr. Medical Writing Coordinator
Document Specialist. Electronic FDA submissions
Tags for this Online Resume:
Protocols, eCTD, Document Specialist, CSRs, FDA Submissions, publishing
Medical Scientist - 20 Years of Experience - Near 86314
Obtain permanent senior medical writer position in CRO or pharmaceutical or medical device company (regulatory or publications).
Tags for this Online Resume:
Medical Writing, Regulatory Submissions, Publications, CTD, NDA, PMA, Clinical Scientist, CSR, Protocols
Quality Assurance Specialist - 8 Years of Experience - Near 84094
Tags for this Online Resume:
Selenium, Loadrunner, CSM, Webmethods, CTD
Featured Profile
Research
To obtain a challenging position within the Pharmaceutical industry or medical devices industry that will allow me to use my experience to play a key role in Clinical Research studies and projects, and/or product development with medical devices.
Tags for this Online Resume:
Clinical Pathology, laboratory method development, IQ, OQ, PQ, instrumentation, validation of medical devices, Regulatory, GLP, GCP, IRB, TMF, Project Manager, Documentation Specialist, Scientist, Archives
Research
To obtain a challenging position within the Pharmaceutical industry or medical devices industry that will allow me to use my experience to play a key role in Clinical Research studies and projects, and/or product development with medical devices.
Tags for this Online Resume: Clinical Pathology, laboratory method development, IQ, OQ, PQ, instrumentation, validation of medical devices, Regulatory, GLP, GCP, IRB, TMF, Project Manager, Documentation Specialist, Scientist, Archives
