Regulatory AffairsMedical Writing Sme

Axle 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 nationally and abroad. 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).

Axle is seeking a Regulatory Affairs Medical Writing SME  to join our vibrant team at the National Institutes of Health (NIH) supporting the  located in Rockville, MD. 

Benefits We Offer:

• 100% Medical, Dental & Vision Coverage for Employees
• Paid Time Off and Paid Holidays
• 401K match up to 5%
• Educational Benefits for Career Growth
• Employee Referral Bonus
• Flexible Spending Accounts:
  • Healthcare (FSA)
  • Parking Reimbursement Account (PRK)
  • Dependent Care Assistant Program (DCAP)
  • Transportation Reimbursement Account (TRN)

Position Summary

Axle is seeking a Senior Medical Writer & Regulatory Affairs Consultant to support the National Institutes of Health (NIH) Blueprint Neurotherapeutics Network (BPN). This role provides scientific leadership and regulatory expertise throughout the drug discovery and development process by preparing, reviewing, and coordinating regulatory submissions while ensuring compliance with FDA regulations, ICH guidelines, and industry best practices.

The successful candidate will collaborate with multidisciplinary scientific teams to develop high-quality regulatory documentation, provide strategic regulatory guidance, and support the successful advancement of therapeutic development programs.

Responsibilities

• Serve as the medical writing and regulatory affairs subject matter expert on NIH Blueprint Neurotherapeutics Network (BPN) Lead Development Teams.
• Prepare, edit, review, and coordinate regulatory submissions, including:
  • Investigational New Drug (IND) applications
  • IND amendments
  • Investigator Brochures (IBs)
  • Clinical protocols
  • Drug Master Files (DMFs)
  • FDA Form 1572 and related regulatory documentation
• Ensure regulatory documents are scientifically accurate, complete, and compliant with FDA regulations and ICH guidelines.
• Advise investigators and project teams on regulatory strategy throughout the drug development lifecycle.
• Assist researchers in obtaining and maintaining regulatory approvals for drugs, biologics, medical devices, and related healthcare products.
• Manage regulatory documentation, submission timelines, and document repositories in accordance with regulatory requirements.
• Develop templates, standard operating procedures (SOPs), and internal guidance documents to support regulatory compliance.
• Conduct regulatory research to monitor emerging regulations, guidance documents, and industry trends.
• Perform technical reviews of scientific reports, publications, presentations, and clinical documentation to ensure regulatory compliance.
• Interpret applicable laws, regulations, and guidance documents and communicate requirements to research teams.
• Coordinate communications with regulatory agencies regarding submissions, regulatory strategies, and requests for clarification.
• Manage internal regulatory activities including audits, inspections, registrations, and compliance reviews.
• Develop remediation plans and corrective actions based on internal compliance assessments.
• Collaborate with scientists, clinicians, medical writers, and data scientists to improve regulatory processes and documentation systems.
• Participate in cross-functional meetings and provide strategic regulatory guidance throughout research and clinical development programs.
• Support continuous improvement initiatives by i