Director, Global Medical Review Committee Business Owner

The Role

The Global MRC Business Owner is a crucial role within Moderna's Medical Affairs team. The Global MRC Business Owner is accountable for the global review and approval process for medical and scientific materials, such that the process facilitates and ensures accuracy, integrity, and high quality of Moderna materials intended for medical and scientific exchange, as well as their compliance with scientific exchange standards, industry regulations and market health authority guidelines.

In their role, the Global MRC Business Owner works closely with Medical Affairs leadership and teams, material owners, regional MRC Chairpersons and coordinators, internal and external reviewers, Regulatory, Legal and Clinical Development colleagues across regions to jointly ensure high review process performance and high review quality – and to adjust the process to evolving business needs and the legal/regulatory environment while delivering continuous improvement. 

Moderna seeks candidates aligned with its culture centered on bold, collaborative, curious, and relentless values, which enable innovation in mRNA-based vaccines and therapeutics to benefit patients.

This is an exciting time to join Moderna as we expand our product reach globally to hundreds of millions of people and experience acceleration in our pipeline and late phase development, thereby poising Moderna for substantial growth in the upcoming years.  This role will be a key contributor to Moderna’s future success in making a transformative impact to patients through our vaccines and therapeutics using our mRNA platform.

Here’s What You’ll Do

• Accountable for MRC process implementation and process facilitation across Medical Affairs globally

• Anticipate and facilitate scaling of the MRC process across regions and teams as new markets and disease areas are added

• Responsible for the Standard Operating Procedure for Review and Approval of Non-Promotional Material

• Responsible for the Scientific Exchange Policy

• Responsible for the electronic review system for non-promotional material reviews; provide system access and facilitate training for all users

• Accountable for effectively onboarding reviewers and for training project owners and reviewers on the MRC process, submission requirements, quality checklists and applicable guardrails – and for ongoing high-level training of all Medical Affairs staff and new joiners

• Collaborate with regional MRC Chairpersons in providing general direction, answering questions and resolving issues related to MRC

• Accountable for maintaining and regularly updating the MRC Playbook that outlines review requirements and detailed process steps per market

• Routinely audit material submission quality and fulfilment of review requirements

• Regularly track and report relevant KPIs for medical review process performance across Medical Affairs

• Maintain close links with regional and therapeutic area teams to understand evolving content development, planned activities and resulting review requirements across geographies

• Drive capacity planning based on consolidated view of content pipeline / upcoming MRC submissions and expected timelines together with regional MRC Chairpersons

• Drive strategic direction of MRC function and help determine and implement optimized staffing model

• Innovate and drive continuous improvement and automation in close collaboration with relevant stakeholders (e.g., reference anchoring, proof-reading, notifications for new content and materials in development, modular content, operational efficiency, etc.)

Here’s What You’ll Need (Minimum Qualifications)

• A minimum of 10 years of experience in or with biopharma industry, preferably in positions related to scientific/medical communication and medical affairs

• Prior experience and comprehensive understanding of medical/legal/regulatory review process in biopharma

• Prior experience and comprehensive understanding of healthcare compliance for medical content sharing with external customers across key global markets

• Experience working with vendors, and relationship management.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Global experience working to support content needs for different jurisdictions (ex: Europe, Japan, Australia, Korea, US, Canada) is highly preferred

• Strong communication skills with ability to influence decisions across functions, both inside and outside of Medical Affairs.

• Ability to work in a complex matrix setting.

• Experience working with management and consulting with key business stakeholders, including an ability to inf