Regulatory Project Manager

General Summary: The OCE requires services to provide technical support and analysis to achieve oncology program process improvements across functional scientific teams, programs and furthering organizational initiatives to solve complex data challenges and research projects pertinent to the assessment of the risks associated to the use of drugs and therapeutic biologics. Additional objectives of this effort are to: Support improvement of benefit-risk management decision making at OCE, Support improvements of external engagement and communication of oncology outcomes from oncology programs decision making at OCE and Improve the quality of data, data sets, and methodologies used for decision making at OCE.

Essential Job Functions: 

• provide services relating to Clinical Regulatory Programs, Research and Development Program, the Digital Oncology Tools Project (DOTP) and support OCE data science workstream including data aggregation and analytic projects to support both regulatory review and regulatory science.
• Assess formation and implementation of selected Clinical Regulatory Programs.
• Coordinate with multiple FDA Centers/Offices and external stakeholders to determine best practices to anticipate and resolve potential oversight challenges.
• Assist in the aggregation and visualization of clinical trial datasets to facilitate and advance innovative trial designs, endpoints and other drug development tools used for decision.
• As identified, review and evaluate clinical study protocols and reports submitted in NDAs, supplemental NDAs, new INDs, new protocols, and protocol amendments, and Emergency INDs, compile data to prepare special reports, analyze data and participate in the publishing and presentation of findings.
• Assess the current state of the Digital Oncology Tools project and progress.
• Perform and document physical assessments and patient histories.
• Predict and analyze trends in patient conditions and develop a patient management plan in response to the data obtained.
• Communicate and collaborate with the multidisciplinary research team to ensure that patient management strategies are successful in meeting patient care and/or research needs.
• Assist in designing and implementing specific protocols within the digital oncology portfolio.
• Participate in a post award orientation.
• Meet with and capture inputs from Oncology Programs that direct cross-cutting activities which span across multiple organizational/functional components in the FDA. The programs selected will be considered Key Stakeholders.
• Develop a work plan.
• Assess risk management maturity in oncology programs in OCE.
• Develop processes, procedures, techniques, frameworks, roadmaps, communications, digital tools and methodologies to enhance key benefits/risk decision making and communications in the oncology program that direct cross-cutting activities which span across multiple organizational/functional components in the FDA.
• Coordinate strategic tracking on up to 6 projects at various stages of development concurrently.
• Evaluate and facilitate the workflow of the OCE Scientific Collaborative research priority areas to ensure that it OC/OCE/Subject Matter Expertise conforms to the project plan and deliverables.
• Assist in the development of performance metrics and new processes, techniques and standards that drive performance and process management.
• Identify, prioritize, and drive the implementation of process enhancements and criteria-based decision-making for project involvement and decision making.
• Prepare and submit a final report that includes findings and recommendations.

Education Requirement: MS/PharmD/MPH

Experience Requirement: Minimum twelve (12) years of specialized experience in operations or management relevant to the applicable task; or clearly demonstrated to the selecting official, through prior job performance or education, an ability to perform the duties of this position.

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:

1. Excellent verbal and written communication skills. 
2. Excellent interpersonal and customer service skills.
3. Familiar with a variety of the field’s concepts, practices and procedures.
4. Proficient in Microsoft Office Suite and Adobe Creative Suite.
5. Demonstrated skills in writing and editing.
6. Thorough knowledge of media operations.
7. Demonstrated success in implementing strong communication campaigns. 
8. Excellent organizational skills, attention to detail and ability to manage workload and prioritize appropriately.
9. Excellent problem-solving skills with ability to analyze situations, identify existing or potential problems and recommend solutions.
10. Ability to work independently as well as collaboratively as a member of a team. 

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.

Diversity, Inclusion, & Engagement at Brillient:

At Brillient, we not only accept difference, we promote it, we embrace it, and we thrive on it for the betterment of our patients, our employees, and our culture.

We are proud to be an equal opportunity workplace and an affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status or any other status protected under applicable law.

Job Requirements: