Sr. Manager, Global Medical Affairs Grants & Contracts

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we’ve been guided by our passion for not settling for “ordinary” in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina, our European headquarters is in Dublin, Ireland and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow us on LinkedIn and Instagram.

 

JOB SUMMARY:

The Senior Manager, Global Medical Affairs Grants & Contracts, will provide leadership and operational expertise to support the Global Medical Affairs team across our portfolio of products. This role requires an experienced professional with experience in grants and external research collaborations, project and team management, vendor management, contracting, and internal communications.

 

ESSENTIAL DUTIES & RESPONSIBILITIES:

Grants & Research

• Serve as global lead for Grants program and Investigator-Initiated Study (IIS) programs to manage day-to-day grant management, including reconciliation and analysis of monthly financial statements. Maintains communication to report and address any grant-related administrative or compliance issue in a timely manner. Ensures all cost transfers are prepared with appropriate backup documentation.
• Review grant and sponsored research requests for completeness, prepare for and coordinate all committee meetings, maintain budgets, as well as regular communication with grant/IIS requestors to manage trackers/milestones.
• Oversees pre-award and post award sponsored research activities for units with highly complex grants. Oversees the post-award review of funding including government and non-government grants on behalf of the departments and its functional groups to assure institutional and sponsor compliance, budgetary appropriateness, and compliance of grant and contract awards to applicable governmental or other sponsor guidelines. Submits fiscal reports as required. Manages requests to re-budget when necessary.
• Support sponsored research activities including planning, analyses, and implementation of strategies to facilitate initiatives in negotiation and execution of research agreements. Interpret regulations and guidelines of programs funding with complex and broad guidelines for spending. Develop, negotiate, and maintain subcontracts under prime contracts. May submit electronic proposals and assist with problems.

Contracting

• Responsible for management of fair market value (FMV) activities including partnership with Compliance for aggregate spend reporting and monitoring.
• Serve as global contract lead, supporting US, Europe, and rest of world contracting operations and processes, including management of all healthcare provider and vendor contracts
• Independently manage contract process (Master Service Agreement, Service Agreement, Work Orders, Change Orders, Change Notification Process) with external suppliers, coordinating the processes and negotiations internally and externally.
• Appropriately escalate problematic suppliers and contractual terms.
• Assess submitted contracts, coordinate review with functional / project leads, returns collated comments to appropriate parties, and ensures that all comments are incorporated by in future drafts.
• Work with management, compliance, legal counsel, and site personnel to generate contracts and consulting agreements, policies, and SOPs.

Operations

• Support Global Medical Affairs operations needs including Vendor Management, Internal Communications Strategy and Planning, and Field Medical Operations
• Assist with operations for planning advisory board meetings, including scheduling and organizing meeting space and activities, preparing materials, leading preparation meetings, live documentation and distribution of minutes and materials.
• Maintain and manage GMA databases (e.g., publications, article