Associate Director, Mlrc (Medical, Legal Regulatory Commercial) Operations

Location: United States, East Coast (Remote)

Job Summary

Role Summary

The Associate Director, MLRC (Medical, Legal, Regulatory Commercial) Operations, is essential to the potential launch of Autolus lead CAR-T program. This role's primary responsibility will be building out and standing up of the Medical, Legal, Regulatory, and Commercial (MLRC) operating working group. This includes process development, enhancements, meeting management, editorial proofing, and leading prioritization efforts at launch ensuring materials are approved in a compliant manner. Additionally, this role will support US Commercial Congress logistics, vendor credentialling needs, Sponsorship submissions as requested.

Key Responsibilities

• Manage and coordinate the MLRC (Medical Legal Regulatory Commercial) review program including Veeva PromoMats, timelines, meeting organization, & material review process

• Support creation & delivery of Veeva PromoMats training as well as onboard all internal and external new users.

• Schedule and manage all MLRC live meetings including documenting meeting minutes and assigning ownership.

• Work closely with internal and external stakeholders to proactively plan and prioritize review of branded and unbranded materials, as well as mitigated and/or troubleshot any potential conflicts that arise.

• Receive and distribute review materials via electronic workflow system and prepare meeting agendas.

• Facilitate and record changes on review materials in live MLRC meetings.

• Validate/confirm comments and changes are deployed as required/appropriate.

• Ensure appropriate approvals stamps are recorded.

• Ensure review committee time is used efficiently (estimate time to complete review of materials; adjust agendas to accommodate reviewer schedule changes; prioritize/reprioritize review items based on business needs)

• Work with the cross-functional team to evolve Veeva PromoMats features and functionality as we move through the process of commercialization.

• Support US Commercially lead Congress logistics, as appropriate.

• Manage vendor credentialling needs for field as required, as needed.

• Support Sponsorship submissions, as needed.