Global Medical Affairs Manager

Responsibilities:

For all grant/project types including Independent Medical Education, Corporate Funding of Sponsorships and Donations and Patient Advocacy programs:

Grant System Support

• Collect and review internal and external user feedback and issues, submit and manage tickets to grant system vendor, determine system improvements and customizations and work with external vendor and Apellis IT Business Partner to implement

Manage Contracting

• Serve as main point of contact for external contract negotiations for assigned program and therapeutic area(s)

• In partnership with Legal, oversee the process to ensure contracts are executed in a timely and compliant manner

• Serve as business owner to enter/manage all grant related contracts in the legal Agiloft CLM system

Independent Medical Education

• Work with Medical Therapeutic Area Leads to set up and manage Request for Proposal (RFP), develop and execute the communication plan

• Manage the Review process to ensure application completeness, schedule review committee meetings and ensure timely completion of review materials

• Manage the educational activity within the GMS, ensuring status updates, activity tracking, reconciliation, closeout, reporting processes and recommending enhancements to processes as identified

• Identifies and escalates potential compliance questions and concerns, as needed

Corporate Funding

• Manage the Review process to ensure application completeness, schedule review committee meetings and ensure timely completion of review materials

• Perform daily operational and project management activities related to the medical affairs sponsorship processes (i.e., intake, review, tracking, change of scope, contract, payment, reconciliation, closeout, and reporting processes) recommending enhancements to processes as identified

• Serve as main point of contact with key organization to manage the benefits associated with a medical sponsorship or membership (such as logos, registrations and congress activities and/or medical exhibit booth related support as needed

• Identifies and escalates potential compliance questions and concerns, as needed

Other Medical Affairs Operations

• Assist with ad hoc projects and workstreams related to the Medical Affairs Operations function

Capabilities:

• Experience working in medical affairs, external education programs, scientific/educational granting preferred

• Knowledge of and experience with legal and regulatory guidelines associated with independent medical education and sponsorship grants from the Accreditation Council for Continuing Medical Education (ACCME), healthcare professional, government agencies, industry organizations and Apellis Ethicand Compliance

• Ability to work with external and internal partners and teammates in a variety of time zones both domestically and internationally

• Possess exceptional communication skills, both oral and written with the ability to influence internal and external stakeholders

• Strong analytical skills and capabilities

• Demonstrable project management skills; proven ability to manage multiple tasks to conclusion, within allotted timelines/deadlines, and without compromise to quality of work output

Qualifications:

• Bachelor’s Degree required

• Minimum 3-5 years’ pharmaceutical industry with a focus in grant operations, grant management, or a similar medical affairs operations role

• Capable of working independently on multiple projects with ability to prioritize tasks and meet strict deadlines

• Experience working with grants management systems, such as iEnvision, CyberGrants, Veeva Events CRM etc. preferred

• Experience with purchase orders, invoicing, and familiarity with SAP preferred

• Experience working in rare disease biotech, preferrable

• Demonstrated aptitude to learn new skills, systems, and software

• High attention to detail and accuracy

Job Type: Part-time

Salary: $60.00 - $65.00 per hour

Expected hours: 20 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Schedule:

• 4 hour shift
• Monday to Friday

Experience:

• Grant management systems: 7 years (Required)
• Procurement management: 7 years (Required)
• Biotechnology: 6 years (Preferred)

Work Location: Remote