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Brillient is seeking an experienced Consultant personnel to join our team supporting a federal contract in Silver Spring, MD. This position requires U.S. Citizenship or a permanent resident and the ability to obtain and maintain a Government public trust level security clearance. Candidates must have lived in the United States for at least three out of the past five years prior to your application date. You will also meet the residency qualifications if you lived abroad while on government or military duty or if you were a dependent of a federal employee of military member.

JOB DESCRIPTION:

Confers with client executive management using line of business expertise to define the client's strategic business goals and advises in the reengineering of business processes to meet these goals. Has demonstrated relevant experience in one or more areas to include: telecommunications, ADP, systems design or engineering, clinical research, finance and budgeting, logistics, market research, intelligence support, contracting and procurement, occupations and personnel management. Analyzes client requirements and recommends development, management or acquisition strategies. Assists clients in developing strategic plans and concepts. Advises clients on the impact of new legislation or new technologies that are relevant to their organization. Recognized in the professional community as an "expert" in the technical/specialty area being addressed. Knowledge on Risk Evaluation and Mitigation Strategies (REMS), Structured Query Language (SQL), eXtensible Markup Language (XML), and the FDA Structured Product Labeling (SPL). Ability to understand and develop standards relating to data management applying best industry practices, data management tools and techniques. Experience in data quality processes and standards to ensure the adequacy and relevance of the data to be consumed by key informatics implementations that support REMS processes.

Specific tasks shall include, but not be limited to, the following:

• Serve as a consultant to help organization finalize the draft guidance based on industry's docket submissions on the draft guidance, updating terminology, providing instructions and a review guide for submissions, develop the implementation guide and validation procedures

• Serve as the consultant primary author and editor to capture the business requirements for an RFI on the development of a technology or existing commercially-available applications, to provide a REMS Web Portal for stakeholders that allow them to meet the REMS requirement such as, but not limited to, enroll, take training, complete certification and renew certification, and/or document and verify safe use conditions for any drug subject to REMS requirements in a single location. Provide recommendations that enable and assist in the drafting of the RFI.

• Review proposals submitted in response to the RFI. Work closely with subject matter experts and senior leaders to collect, interpret and synthesize information submitted.

• Perform quality reviews of related documents to ensure accuracy, consistency with Agency laws, regulations and policies, includes all important concepts, meets the writing style requirements of the agency, follows the appropriate template and are written at an appropriate comprehension level for the intended audience.

• Produce working and final drafts of each written document for review by SMEs and senior leaders within organization's specified timeframes.

• Develop specifications describing the analysis to be performed, pre-conditions and/or data requirements, required inputs, processes to be performed (process flow), description of functions performed, and analytical methods used, and outputs produced.