Overview

Colorado Springs, CO, 80509
icrunchdata Network
Experience : 12 years of technical writing experience and in the medical device industry Expert and technical lead with proven experience. Education: Bachelors/Masters in a scientific/technical discipline or equivalent; advance degree (M.S., Ph.D.) desired, experience in the pharmaceutical, biological, or medical device development Job Duties: Experience writing regulatory submissions such as NDAs/INDs, BLAs Strong knowledge of FDA, ICH, and GCP guidelines Regulatory/Clinical writing experience Responsible for Regulatory/Clinical writing assignments Support the writing of CSRs, Protocols, IBs Summaries of Safety and Efficacy Responsible for the preparation of documents across all phases of clinical development Contribute to clinical studies across several therapeutic areas. Responsible for the preparation of documents across all phases of clinical development Contribute to clinical studies across several therapeutic areas Assist with documentation for pre-submission and submission packages, as required. Develop, maintain and update templates for clinical documents including protocols, clinical study reports, investigational brochures, Integrated Summaries, literature reviews, and associated documents up to and including regulatory dossier to standardize the development process across disciplines. Collect data by interviewing technical and process specialists, researching written material, attending training and demonstrations, using products, and observing users. Independently synthesize and describe complex scientific data, and be well versed in scientific terminology, principles, and publishing standards. Generate documents that meet the appropriate quality standards, to support formal verification and validation activities. Lead and implement changes to improve the collaborative document creation process. Nesco Resource is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities. Job Requirements:

[...]

Source: