Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Overview
Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Scientific Program Manager join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC).

Responsibilities

• Coordinate various day-to-day functions related to managing regulatory projects, oversee all aspects of regulatory operations projects, regularly interact with cross functional departments, to ensure timeliness and compliance with the FDA statutory requirements. Support Regulatory Science and Strategy Program (RSSP) staff.
• Coordinate and ensure completion and compliance of regulatory documentation, such as clinical study protocols, informed consent documents, chemistry manufacturing and control (CMC) documents, and nonclinical study report summaries.
• Coordinate the Investigational New Drug (IND) application and amendments throughout its lifecycle which includes:
• Oversee timelines and coordinate Investigational IND application portfolio of products consisting of vaccines and monoclonal antibodies for compliance with the Food and Drug Administration (FDA) regulations for use of investigational products in humans.
• Prepare and coordinate VRC’s translational Science support programs and manage timelines for Development Safety Update Reports (DSURs) and Annual Safety Reports for all VRC product portfolios.
• Coordinate with Regulatory Scientists and other programs within VRC to develop Investigator’s Brochure (IB) timelines for active studies, lead quarterly meetings with the subject matter experts and assess the status and progress of IB revisions.
• Provide expert regulatory operation support in the preparation, compilation and filing of IND submissions.
• Manage documents in electronic common technical document (eCTD) compliant format as required for new and existing INDs.
• Coordinate submission timelines with publishing vendor.
• Perform Technical Quality Control (QC) review of submissions and new INDs and MFs.
• Serve as an expert on the NIAID eCTD system, ensuring regulatory applications and FDA communications are maintained.
• Coordinate with responsible CORs and other VRC programs to track the status of the new TOROs, assist with drafting new TOROs, assist with the coordination of the reviews and approvals for awarded contracts.
• Expert management and maintenance of Master Control CQMS system, serve as a Product Champion and Technical expert including user management, document control, and training setup and verification.
• Serve as an expert on Clinical research Management System (CRMS), Write and review technical documentation, perform User Acceptance Testing on new software updates for Regulatory Module.
• Provide regulatory operations support to the VRC regulatory office through document control management and quality assurance.
• Work on special projects in the RSSP, VRC in order to assist RSSP staff in meeting VRC, and FDA timelines.
• Assist RSSP personnel with developing templates and letters for regulatory submissions to the FDA and sites.
• Verify the integrity of sponsor files, ensure the availability of clinical and non-clinical materials, review the required documentation in the document control system according to the current practices and applicable guidelines, and check for consistency with the contents of sponsor files.
• Track regulatory correspondence, activity, and maintenance of various internal electronic databases. Ensure all FDA communications, both formal and informal are documented in the NIAID electronic document management systems.
• Coordinate and maintain the tracking and reviewing of regulatory submissions including annual reports, IND/MF applications and other regulatory amendments.
• Develop standard operating procedures, provide strategic advice, and communicate with stakeholders which may include recommending applicable education and training to personnel for assurance of regulatory compliance.

Experience Required / Requirements

• Minimum of a master’s degree in related field is required with at least Three (3) – Five (5) years of experience in regulatory affairs and project management related to the approval of vaccines and therapeutics for human use.
• Proficiency with common project management (e.g., MS Project, VISIO etc.) and various document control applications.
• Demonstrated expertise with using Lorenz docuBridge eCTD electronic publishing software tools.
• Extensive knowledge of MS Word, Project, PowerPoint, Excel, and other MS Office 365 applications and Adobe Acrobat.
• Experience with the administration and management of Clinical Research Management System (CRMS) and Master Control Clinical Quality Management System (CQMS).
• Demonstrates strong organizational and time management skills and ability to effectively manage multiple tasks while continuously assessing teams priorities.
• Thorough understanding of regulatory affairs or vaccine development experience gained with direct involvement in regulatory submission preparation.
• Ability to collaborate successfully with all levels and roles in cross-functional teams.
• Ability to manage documents of greater complexity or variety.
• Excellent written, verbal, interpersonal, analytical, critical thinking, project management and organizational communications skills
• Experience in coordination of regulatory activities within internal and external teams.

Benefits

• 100% Medical, Dental & Vision premium coverage for Employees
• Paid Time Off (Including Holidays)
• Employee Referral Bonus
• 401K Match
• Tuition reimbursement and professional development opportunities
• Flexible Spending Accounts:
• Healthcare (FSA)
• Parking Reimbursement Account (PRK)
• Dependent Care Assistant Program (DCAP)
• Transportation Reimbursement Account (TRN)

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• On-site gym
• Paid time off
• Referral program
• Tuition reimbursement
• Vision insurance

Experience level:

• 3 years
• 4 years
• 5 years

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Master's (Required)

Experience:

• Regulatory Affairs: 3 years (Required)
• Human Use Therapeutics: 1 year (Required)

Ability to Relocate:

• Bethesda, MD 20892: Relocate before starting work (Required)

Work Location: Hybrid remote in Bethesda, MD 20892