Job Description

Title: Senior IIS and Grants Manager

Assignment Duration: 6 Months

Location: King of Prussia, PA

Work Arrangement: Hybrid (3 days onsite per week; onsite days are flexible)

Schedule:

Full-time (40 hours/week)
Eastern Time business hours; flexibility required due to a global team

Position Summary

The IIS & Grants Manager is responsible for driving operational excellence across Investigator-Initiated Studies (IIS) and Medical Grants within Medical Affairs. This role partners closely with Disease Area (DA) teams, regional medical teams, and cross-functional stakeholders to ensure efficient, compliant, and high-quality execution of grants and IIS processes.

The position plays a critical role in governance, process standardization, budget oversight, and inspection readiness, ensuring that all IIS and grants activities align with medical strategy and organizational objectives in a global, matrixed environment.

Key Responsibilities

1. IIS & Grants Operations (Primary Focus)

Lead end-to-end coordination of IIS and grants processes, including intake, review cycles, governance forums, and milestone tracking.
Ensure strong alignment of IIS and grants activities with medical strategy and organizational priorities.
Standardize and harmonize processes across legacy organizations, supporting integration and consistency.
Oversee governance cadence, including review committee planning, documentation, and decision tracking.
Ensure operational readiness through adherence to SOPs, complete documentation, and effective cross-functional handoffs.

2. Budget, Timeline & Performance Management

Partner with Finance to plan, track, and reconcile IIS and grants budgets.
Identify and communicate financial variances, risks, and opportunities while maintaining audit-ready documentation.
Develop and maintain integrated project plans and milestone trackers (e.g., Gantt schedules) for IIS and grants portfolio activities.
Monitor progress against timelines, proactively mitigate risks, and provide regular status updates and dashboards.

3. Process Excellence, Quality & Compliance

Ensure all IIS and grants processes meet internal SOPs, policies, and external regulatory requirements.
Maintain audit- and inspection-ready documentation across all activities, including decisions, approvals, and financial tracking.
Support SOP development, updates, and implementation aligned with evolving business needs.
Drive continuous improvement initiatives, including process optimization, template standardization, and lessons learned.

4. Tools, Reporting & Insights

Build and maintain dashboards, trackers, and portfolio reporting tools (e.g., Insights Modul, Excel-based trackers).
Deliver clear, concise reporting on IIS and grants portfolio performance, including KPIs, risks, and mitigation strategies.
Generate executive-ready summaries and insights to support data-driven decision-making for senior Medical Affairs leadership.

5. Cross-Functional Collaboration & Communication

Act as a central liaison across Medical Affairs, Finance, Compliance, Legal, and external partners.
Translate operational updates into clear narratives for leadership, highlighting progress, risks, and decisions needed.
Support change management initiatives related to IIS and grants processes, tools, and governance models.

Required Qualifications

Bachelor's degree required.
Advanced degree and/or PMP or equivalent project management certification is desirable.
8–10+ years of relevant experience in pharma/biotech within Medical Affairs operations, clinical/medical program management, or closely related functions in a global, matrixed setting.
Demonstrated experience managing IIS and/or Medical Grants processes, including governance and compliance requirements.
Proven ability to lead cross-functional initiatives without direct authority.
Strong proficiency in Microsoft Excel and PowerPoint.
Excellent communication and stakeholder engagement skills, with experience presenting to senior leadership.

Preferred / Nice-to-Have Qualifications

Process design and continuous improvement experience (templates, SOPs, training).
Familiarity with international compliance regulations and requirements.

Applicant Notices & Disclaimers

For information on benefits, equal opportunity employment, and location-specific applicant notices, click here

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $60.00/hr - $72.00/hr.

Senior IIS and Grants Manager