Job Description
Responsibilities for this Position
Location: USA MD Fort Detrick
Full Part/Time: Full time
Job Req: RQ206020
Type of Requisition: Regular
Clearance Level Must Currently Possess: None
Clearance Level Must Be Able to Obtain: None
Public Trust/Other Required: NACI (T1)
Job Family: Technical Documentation
Job Qualifications: Skills: eCTD, Investigational New Drug Application (IND), New Drug Application (NDA), Regulatory Documents, Regulatory Writing
Certifications: None
Experience: 5 + years of related experience
US Citizenship Required: Yes
Job Description: GDIT's Military Health team is hiring a Medical Writer to support the Office of Regulated Activities (ORA) under the DoD (Dept. of Army) located at Ft. Detrick in Frederick, Maryland. The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring. This is a hybrid position and will report onsite 2-3 days a week at Ft. Detrick in Frederick, Maryland. Must reside within commuting distance. HOW YOU WILL MAKE AN IMPACT: - 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, MS Word, and applicable templates and standards to produce documents and dossiers compliant with FDA and Office of Regulated Activities (ORA) regulations and standards.
- Lead and manage writing projects.
- Track and meet deadlines for writing projects.
- Attend, participate in, and organize meetings.
- Provide routine reports and updates to team members, project managers, and Government leaders.
- Provide subject matter expertise on regulatory documentation and version control.
- Participate in special projects as required.
WHAT YOU'LL NEED TO SUCCEED: - 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.
- Experience writing investigational new drug (IND) application documents in Common Technical Document (CTD) format
- Proven editorial and MS Word formatting skills
- Project management skills, including the ability to be proactive, multi-task, work collaboratively in a team environment, and meet deadlines.
- Knowledge of current regulatory guidelines related to regulatory communications
- The ability to work independently and as part of a team and oversee the activities related to US Food and Drug Administration (FDA) dossier preparation
- Have excellent Microsoft Office skills and experience with eCTD formatting.
- Excellent written and oral communication skills.
- Must be a US Citizen with the ability to obtain a favorable NACLC T3 security investigation prior to start date.
- This is a hybrid position and will report onsite 1-2 days a week at Ft. Detrick in Frederick, Maryland. Must reside within commuting distance.
WHAT GDIT CAN OFFER YOU: - Challenging work that makes a real impact on the world around you
- Internal mobility team dedicated to helping you own your career
- 401K with company match
- Diverse, highly collaborative teams
- Professional development, education assistance, certification and training opportunities
#GDITHealth #militaryhealth #GDITLabScienceJobs #GDITFedHealthJobs The likely salary range for this position is $82,283 - $111,323. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.
Scheduled Weekly Hours: 40
Travel Required: Less than 10%
Telecommuting Options: Hybrid
Work Location: USA MD Fort Detrick
Additional Work Locations: Total Rewards at GDIT: Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.
We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.
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Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans
PI277510020
GDIT's Military Health team is hiring a Medical Writer to support the Office of Regulated Activities (ORA) under the DoD (Dept. of Army) located at Ft. Detrick in Frederick, Maryland. The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring. This is a hybrid position and will report onsite 2-3 days a week at Ft. Detrick in Frederick, Maryland. Must reside within commuting distance. HOW YOU WILL MAKE AN IMPACT: - 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, MS Word, and applicable templates and standards to produce documents and dossiers compliant with FDA and Office of Regulated Activities (ORA) regulations and standards.
- Lead and manage writing projects.
- Track and meet deadlines for writing projects.
- Attend, participate in, and organize meetings.
- Provide routine reports and updates to team members, project managers, and Government leaders.
- Provide subject matter expertise on regulatory documentation and version control.
- Participate in special projects as required.
WHAT YOU'LL NEED TO SUCCEED: - 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.
- Experience writing investigational new drug (IND) application documents in Common Technical Document (CTD) format
- Proven editorial and MS Word formatting skills
- Project management skills, including the ability to be proactive, multi-task, work collaboratively in a team environment, and meet deadlines.
- Knowledge of current regulatory guidelines related to regulatory communications
- The ability to work independently and as part of a team and oversee the activities related to US Food and Drug Administration (FDA) dossier preparation
- Have excellent Microsoft Office skills and experience with eCTD formatting.
- Excellent written and oral communication skills.
- Must be a US Citizen with the ability to obtain a favorable NACLC T3 security investigation prior to start date.
- This is a hybrid position and will report onsite 1-2 days a week at Ft. Detrick in Frederick, Maryland. Must reside within commuting distance.
WHAT GDIT CAN OFFER YOU: - Challenging work that makes a real impact on the world around you
- Internal mobility team dedicated to helping you own your career
- 401K with company match
- Diverse, highly collaborative teams
- Professional development, education assistance, certification and training opportunities
Job Tags
Full time, Temporary work, Part time, Work experience placement, Work at office, Immediate start, Remote work, Worldwide, Flexible hours, 2 days per week, 3 days per week, 1 day per week,