Health Science Specialist

Qualifications

You must possess a bachelor's or graduate/higher level degree with major study in an academic field related to the medical field - health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained. NOTE: Transcripts must be submitted with application.

• To be creditable - this experience must have been equivalent to at least the GS-11 level in the Federal service.
• Specialized experience includes: developing standard operating procedures (SOPs) directly related to processes for conducting research, creating and documenting processes to ensure research compliance, and performing quality assurance management activities, such as auditing of processes related to executing research protocols.

Physical Demands

The work is sedentary. Typically, the employee may sit comfortably to perform portions of the work. However, there is periodic walking, standing, bending, carrying of light items such as medical records, instructional material, books, and manuals. No special physical demands are required to perform the work.

Duties

Responsible for development and maintenance of standard operating procedures (SOPs), work instructions (WIs), and other supporting documents (SDs) utilized by core MVP staff to ensure cohesive efforts across the program.
Serves as a project manager collaborating with key stakeholders and subject matter experts to develop new or revised SOPs, WIs, and other SDs in accordance with established guidelines and formatting.
Participates in all phases of conduct of MVP Quality Manual efforts, ensuring that goals are being met within established timeframes.
Maintains the MVP Quality Manual SharePoint site and associated tools, collaborates with the Deputy Director - Compliance & Quality Assurance to ensure all documentation is current and accurate including during periodic (e.g. annual) review.
Coordinates with Deputy Director - Compliance & Quality Assurance to develop and manage an auditing process to ensure compliance of core MVP staff with approved procedures.
Understands interdomain connections within and between documented procedures in detail to ensure accurate documentation is represented and consistent.
Conducts quality assurance review of document updates including formatting, spelling/grammar, accurate and sufficient level of detail, and consideration of interdomain impact.
Negotiates corrective actions concerning programmatic issues and basic management of the research program's quality management initiative.
Performs qualitative analyses of procedures to identify potential risks and problematic processes.
Performs other related duties as assigned.

Work Schedule

Full Time - Monday - Friday 8:00am - 4:30pm