The Medical Writer will:

Responsibilities:

• Provide statistical programming support for assigned clinical study study/project 
• Coordinate activities of assigned statistical programming team members 
• Ensure the development of programs and use of project standards for all analysis datasets, tables, listings and figures for assigned project with close cooperation with the study/project statistician. 
• Has deep project knowledge, incl indication relevant issues. Oncology experience is preferred. 
• Participate in the IND/NDA activities, as needed for assigned project 
• Lead & oversee all statistical programming function deliverables required for submissions to regulatory authorities for assigned projects/studies 
• Participate on global teams that evaluate processes and make suggestions for process and system needs and improvements 
• Provide assistance to junior and external programmers in the development of statistical programs 
• Works in close cooperation with other Clinical Operations departments 

Requirements:

• Pharm.D. or Ph.D. in a pharmaceutical science preferred. 
• RPh or RN with previous pharmaceutical industry-based Drug Information experience considered. 
• 1-3 years of Drug Information, Medical Writing or Medical/Promotional review experience preferred. 
• 2+ years of clinical experience preferred. 
• Relevant therapeutic background desired.
• Must be a strong team player and be willing to work in an environment where individual initiative and accountability to the team are required 
• Proficient in MS office applications 

   

Huntington Ingalls Industries – Technical Solutions Division, Integrated Mission Solutions Group (Camber Corporation) provides mission-critical engineering and technical service to Information Technology, Federal Civilian, and National Security, Aerospace & Defense and International government and commercial customers at over 100 locations worldwide.

HII-TSD, Integrated Mission Solutions Group (Camber Corporation) is currently seeking a Technical Writer to work out of our clients Washington, D.C. office.

Duties and Responsibilities (to include but not be limited to the following):

• Responsible for detailed system documentation, updating of help systems, and creation of Job Aids
• Writing, proofreading, and editing technical documentation, such as project life-cycle documentation, user manuals, test cases and test plans
• Analyzing user requirements and problems

Qualifications and Experience:

Required-

• Bachelor’s degree plus two (2) years of professional experience
• Ability to work on entire documentation life cycle, including information gathering, producing document text, and creating illustrations
• A working knowledge of the SDLC and associated methodologies and standards.
• Some experience and familiarity with software testing would be helpful
• RoboHelp experience and/or knowledge
• Knowledge of Agile-Scrum and Waterfall development methodologies is a plus

Security:  

• Applicants selected will be subject to a government security investigation and must meet eligibility requirements for access to classified information
• Must be able to obtain and keep a USPS Sensitive Clearance
• Must be a U.S. Citizen or have a Green Card and have been living in the U.S. for at least the last five years
• Must not have traveled outside of the United States for more than 180 days in the last five years
• All candidates will be subject to a pre-employment background investigation and drug screening per HII requirements.

See Job Description

Works with Program Manager to develop playbook and supporting materials to support large scale transformational program. Must be proficient in PowerPoint and Excel. Must be able to take content and develop high quality PowerPoint presentations.

PowerPoint.

Ability to take content and develop an engaging storyline and high quality PowerPoint presentations.

Able to think creatively.