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Online Resumes with "FDA submissions"

Accomplished Academician turned Medical Writer Available to Communicate Your Data

To find a position that uses my extensive background in biotechnology and medicine to communicate data succinctly.

Tags for this Online Resume: Manuscripts, FDA submissions, Molecular Biology, Animal Studies, Research, Posters

Expectional and Experience CRA - Certified CRA with 9 years experience - c

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.

Ideal Companies: Pharmaceutical companies, CROs

Tags for this Online Resume: Clinical Research Associate , CRA III, Senior CRA, Experienced, Contract, ex

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.

Tags for this Online Resume: Clinical, Project Manager, Data Analyst

QA Manager, Boca raton, FL

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...

Tags for this Online Resume: Quality Assurance, Quality Control, Manufacturing, Teaching, Bio-Statistics, Regulatory

Promotional Materials Manager

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- 20 years experience- Memphis

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...

Tags for this Online Resume: GCP, FDA submission documents, Drug safety, GLP, NDA, Auditor

Featured Profile

Tehnician capable of wearing many hats. "I help people get things done"

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

Tags for this Online Resume: Calibration, Bio Lab, Blood, Design Assement, Preventative Maintenance, Equipment Management, Failure Investigation

Sr. Medical Writing Coordinator

Document Specialist. Electronic FDA submissions

Tags for this Online Resume: Protocols, eCTD, Document Specialist, CSRs, FDA Submissions, publishing

Featured Profile


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

Customer centric, technical sales professional

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.

Ideal Companies: Amgen, VWR, Thermo Fisher, Sigma Aldrich, Microsoft, Amazon

Clinical In-house Monitoring - 13 Years of Experience - Near 08068

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

Tags for this Online Resume: Princeton, Study startup, In house CRA, CTA, Inform, Medidata Rave

Director of Quality - 15 Years of Experience - Near 77086

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.

Tags for this Online Resume: Quality Systems, Medical Device, Regulatory Affairs, 510K submission, CE Mark, Consultant, Director, Vice President