General Summary: Brillient Corporation is seeking an experienced SME to join its Team supporting OCE Oncology Project Renewal Group.

Essential Job Functions:

• Actively participate in all discussions with internal and external oncology subject matter experts for oncology labels discussed under Project Renewal – these include but are not limited to indication, dosing and administration, safety
• Evaluate and review published literature to determine whether study designs and results meet the level of substantial evidence to support a labeling update
• Evaluate and assess the benefit/risk of existing indications and potential new indications
• Document OCE’s thinking in an FDA review document
• Draft proposed labeling updates
• Review the supplement request package to be sent to sponsors
• Review the NDAs submissions by sponsors

Education Requirement: MD, MD/PhD, DO, PharmD, NP (Nurse Practitioner), PA (Physician Assistant)

Experience Requirement: Minimum 18 years of experience working in the relevant area of expertise. Required: At least 1 year clinical oncology experience Preferred but not required: 1 year Prior regulatory experience and familiarity with cancer clinical trials and critical evaluation of trial designs and published literature.

Other Requirement(s): This position requires U.S. Citizenship or a Green Card holder and the ability to obtain and maintain a Government public trust level security clearance. For a candidate that is a Green Card holder, they 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.

Performance Requirements:

• Excellent verbal and written communication skills, as well as recordkeeping.
• Excellent leadership and mentorship abilities to introduce and implement solutions.
• Proficient in Microsoft Office Suite
• Excellent organizational skills and attention to detail.
• Ability to work independently.
• Ability to establish and maintain effective and positive working relationships with all staff and visitors.
• Proficient in the language/terms/jargon in his/her area of expertise.

Equipment Operated: Standard office equipment including computers, fax machines, copiers, printers, telephones, etc.

Work Environment: Work performed in an office environment. Involves frequent contact with staff and customers.

Mental/Physical Requirements: Manual dexterity for office machine operation; stooping, bending to handle files and supplies, mobility to complete errands or deliveries. Must be able to remain in stationary position for extended periods of time. Stress can be triggered by multiple demands and deadlines.

DISCLAIMER: The above statements are intended to describe the general nature and level of work performed. They are not intended to be an exhaustive list of all responsibilities, duties, skills, efforts, requirements, or working conditions. Management reserves the right to revise the job or to require that other or different tasks be performed as assigned in accordance with business demands and/or contractual requirements.