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Online Resumes with "FDA submissions"
To find a position that uses my extensive background in biotechnology and medicine to communicate data succinctly.
My career goal is to have an impact on the entire process of clinical studies. I would like to broaden my horizons beyond the normal CRA role performed and be involved in the entire clinical study from start to finish. I want to be involved in the protocol from beginning (developing the protocol) to the FDA submission. From my previous experiences I know I can have a positive effect on the successful outcome of studies.
I have over 10 years of experience managing clinical trials for drug and medical devices. I have contributed to over seven FDA submissions, numerous publications, patents, presentations.
To contribut to the success of data submissions to clear regulatoy hurdle.
To obtain a position where my education and experience and previous work history would help the firm. I am knowledgeable and have worked with 21 CFR 11, 210 and 211.I was responsible for all 3rd party audits; was the responsible head for all FDA audits and responses; headed the CAPA and OOS Investigations and was involved with International Regulatory submissions as well as all FDA submissions. I was resopnsible for all OO...
Promotional Material Manager with solid experience in the pharmaceutical industry. Successful working with brand managers, brand teams, medical, legal, drug regulatory departments to finalize a high volume of promotional materials and FDA submissions for RX products. Knowledge of FDA guidelines and regulations. Able to work effectively with all levels of management under tight deadlines.
Clinical research professional with over 20 years of experience in both industry and academia. Responsible for all audit activities for multiple phase 1-3 clinical trials. Responsibilities include but are not limited to ICH/GCP compliance. Reviews key study documents such as protocols, informed consents, CRFs, monitor reports, and CSR. Presents protocol and GCP training at Investigator meetings. Mentors and trains junior qu...
Hard-working, detail-oriented professional with record of consistently meeting and exceeding established goals and objectives. Background in medical laboratory testing and operations. Strong supervisory and problem solving skills; able to prioritize multiple tasks while ensuring quality control and continuous improvement. Technical skills include MS Office (Word, Excel, PowerPoint) and Apple operating systems.
Ideal Companies: Start-up
Document Specialist. Electronic FDA submissions
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
I am looking for a stable sales position that will utilize my experience and expertise in customer focused, relationship driven sales. Ideally, the sales/service would be life science related.
Skilled in the planning and implementation of clinical research projects in compliance with ICH-GCP, Regulatory Agencies, and company SOP. Study Start up expert. Proficient in Microsoft Office Applications, CTMS, IVRS/IWRS, INFORM, Medidata Rave. Therapeutic areas: Oncology, Cardiology, Neuroscience, Internal Medicine, including Diabetes. Participated in 3 FDA Submissions, FDA Inspection Readiness and TMF reconciliation
10+ years medical device industry in variety of areas including Regulatory strategy for domestic and international marketing. FDA submissions of 510k and EU submissions of Technical Files for CE Mark. Implementation of Quality Systems per QSR, Health Canada, ISO 13485:2012, Medical Device Directive 93/42/EEC and Active Implantable Medical Device Directive 90/285.