Medical Writer
Posted on: 18 Feb 2021
Fort Detrick, MD
Job Description
General Dynamics Information Technology - Federal Civilian Division is looking for a Medical Writer to join our team to support the Department of Army. This position is based in the Ft. Detrick and Frederick, Maryland areas.
In this role, the Medical Writer will:
* Write, review, edit, and advise on the development of documents and dossiers in an electronic Common Technical Document (eCTD) format, to include IND applications, master files, investigational new device applications, biologics license applications, new drug applications, annual reports, information amendments, clinical protocols and study reports, investigator's/investigational brochures, FDA meeting requests and background materials, responses to FDA requests for information, target product profiles, clinical development plans, manuscripts, white papers, 510k pre-market notifications, and to a lesser extent pre market approvals, and Environmental Protection Agency registration packages.
* Use eCTD format to produce compliant writing products.
* Maintain a writing product tracker to ensure regulatory deadlines are met for annual reports, FDA requests for information, and overall product submission timelines
* Attend meetings to document all regulatory tasks and activities associated with the product development life cycle.
* Provide routine reports and updates to the Government leadership.
* Respond to questions and provide advice on activities and issues related to documentation.
* Participate in special projects as required.
REQUIRED QUALIFICATIONS:
* Bachelor's Degree in Science field or a related discipline, or the equivalent combination of education, professional training, or work experience.
* 5 years of related medical or regulatory writing experience.
* Have excellent Microsoft Office skills and experience with eCTD formatting.
* Excellent written and oral communication skills.
* Must be U.S. citizen and be able to obtain a TI (Public Trust).
Scheduled Weekly Hours:
40
Travel Required:
None
T elecommuting Options:
Some Telecommuting Allowed
Work Location:
USA MD Fort Detrick
Additional Work Locations:
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.nnGDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.
PI130138450
General Dynamics
Falls Church, VA
General Dynamics Corporation operates as an aerospace and defense company worldwide. It operates in five segments: Aerospace, Combat Systems, Information Technology, Mission Systems, and Marine Systems. The Aerospace segment designs, manufactures, and supports business-jet aircraft; and offers business-aviation services, including maintenance, fixed-base operation, government fleet, aircraft management, charter, and staffing services, as well as integrated aviation solutions.
The Combat Systems segment engages in the design, development, production, modernization, and sustainment of combat vehicles, weapons systems, and munitions. This segment offers wheeled combat and tactical vehicles; main battle tanks and tracked combat vehicles; weapons systems, armaments, and munitions; and maintenance, logistics support, and sustainment services. The Information Technology segment provides information technology (IT), IT infrastructure modernization, and professional services, as well as cloud, cyber, software development, systems engineering, and data analytics services and solutions.
The Mission Systems segment offers mission-critical C4ISR products and systems, such as space, intelligence, and cyber systems; ground systems and products; and naval, air, and electronic systems. The Marine Systems segment designs and builds nuclear-powered submarines, surface combatants, and auxiliary and combat-logistics ships for the United States Navy and Jones Act ships for commercial customers.
This segment provides nuclear-powered submarines; surface combatants; auxiliary and combat-logistics ships; commercial product carriers and containerships; design and engineering support services; and maintenance, modernization, and lifecycle support services, as well as repair services for navy ships. The company was incorporated in 1952 and is headquartered in Falls Church, Virginia.
-
IndustryEngineering
-
No. of Employees105,600
-
Website
-
Jobs Posted7128
