Medical Writer (Regulatory Affairs / Submissions)
ICON Government and Public Health Solutions specializes in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with a wide array of research, regulatory, and sponsor services both within the US and around the globe and respond rapidly to global health crises.
Reasonable Accommodation Statement:
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
- Write, review, edit, and/or advise during development of documents such as IND annual reports, protocols, Investigator s Brochures, chemistry, manufacturing, and controls [CMC] information amendments, final study reports, Read-Ahead Packages for FDA meetings, meeting minutes, responses to FDA Requests for Information, and summary sections of INDs, MFs, IDEs, BLAs, and NDAs in Common Technical Document (CTD) format.
- Use Microsoft Office (Word, Access, Excel, PowerPoint) and Adobe software applications, PDF editing software to be able to research and review content effectively.
- Interpret information into clear and concise scientific writing and apply applicable FDA regulations for the writing and publishing of regulatory submissions.
- Use project management principles to communicate effectively (written and verbal) within the Integrated Product Team (IPT) development framework.
- Write, review, edit multi-volume documents requiring advanced word processing and formatting, indexing, generation of table of contents, and manual pagination according to FDA regulations.
- Write, review, edit, electronic Common Technical Document (eCTD) submissions using knowledge of regulations and industry best practices for publishing.
Candidates for positions under ICON Government and Public Health Solutions contracts with the Department of Defense (DoD) may be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency.
WORKING CONDITIONS/PHYSICAL DEMANDS:
Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Laboratory/office environment; may require working evenings and weekends. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to manipulate objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.