Medical and Regulatory Affairs - Cell Therapy Medical Onboarding Manager

Position Description

The Field Medical Cell Therapy Onboarding Manager is a member of a field-based team of scientists who function as an extension of the U.S. Hematology Medical Affairs organization. The CT Onboarding Manager is responsible for verifying medical SOPs and partnering with the Medical Science Liaison to ensure sites are medically qualified as a Client cell therapy institution. This position will liaise internally and externally to provide cell therapy medical onboarding information and verification to support Client and the Medical Affairs department at the direction of Medical Affairs management.

This is a remote-based position and requires professionals with established personal and scientific creditability to interact with Hematology/Oncology centers of excellence.

• Virtually attend site onboarding kick-off meeting for patient journey conversations and support the MSL as needed (e.g. note-taking, site assessment and appropriate documentation)
• Verify medical information and qualification criteria associated with cell therapy medical onboarding at identified cell therapy institutions.
• Review and validate institution SOPs and protocols to meet Client compliance requirements.
• Collaborate with commercial organization to enhance cell therapy onboarding and activation of accounts, including attendance at matrix huddle meetings.
• Provide timely feedback/updates on emerging issues/concerns with MSLs and key internal stakeholders.
• REMS training with Authorized Representative
• Perform supplemental educational trainings of product handling and administration for ide-cel and liso-cel as needed.

• Proven ability to work independently as well as in cross-functional networks.
• Working knowledge of SOP development and implementation in health care systems; previous SOP development experience a plus.
• Technical proficiency in Microsoft systems including experience with health care informatics.
• Current working knowledge of U.S. legal, regulatory, and compliance regulations and guidelines relevant to industry interactions with health‑care professionals.
• Understanding of hospital and clinic processes.
• Excellent organizational, communication and time management skills.

• Minimum requirement MSN, DNP, PA, Pharm
  
  D.
• 3+ years clinical or research experience in hematology.
• Limited travel requirement.