Medical Affairs Strategic Operations Specialist / Manager
Location: Titusville, NJ (Hybrid: 3 days onsite / 2 remote)
Duration: 12 month contract with potential for extension
Travel: Up to 10%
Overview
As a key member of the Strategic Operations Team, the Medical Affairs Strategic Operations Specialist/Manager supports the execution of operational initiatives across Real World Evidence (RWE), Franchise teams, and Therapeutic Area functions. This role is critical to ensuring efficient delivery of medical programs through strong project management, vendor oversight, and cross-functional coordination.
Key Responsibilities
Operational Excellence
- Coordinate across cross-functional teams to ensure seamless execution of medical affairs programs
- Track and deliver against key performance indicators to drive efficiency and effectiveness
- Identify risks proactively and implement solutions to maintain operational continuity
Project Management & Systems Execution
- Lead project intake, setup, and tracking within internal systems (e.g., WESS)
- Manage timelines, budgets, and resource allocation across multiple initiatives
- Support both evidence-generation and non-evidence-generation projects
Financial & Contract Management
- Oversee end-to-end purchase order (PO) lifecycle, including creation, tracking, and reconciliation
- Manage contract requests, invoice approvals, and overall spend tracking
- Ensure compliance with internal financial processes and systems (e.g., Ariba/eMP)
Vendor Management
- Build and maintain relationships with external vendors
- Monitor Statement of Work (SOW) execution and vendor performance
- Track deliverables, budgets, and KPIs to ensure successful outcomes
Evidence Generation Support
- Support operational execution of Real World Value & Evidence (RWVE), Investigator-Initiated Studies (IIS), and collaborative studies
- Facilitate study intake through final deliverables, including submissions (e.g., Totality, ReCAP)
- Partner with cross-functional teams to ensure timely and high-quality study execution
Medical Education (CME) Coordination
- Manage CME request intake process, including portal monitoring and notifications
- Maintain CME tracking tools and ensure documentation is stored appropriately (e.g., SharePoint)
- Ensure compliance and timely processing of all requests
Clinical & Study Operations Support
- Assist in tracking and managing ongoing clinical studies
- Coordinate protocol intake, approvals, and review meetings
- Support transition and setup activities across multiple studies
Process Improvement
- Identify and implement enhancements to workflows and operational processes
- Contribute to continuous improvement initiatives to optimize delivery and scalability
Qualifications
Education & Experience
- Bachelor’s degree required; advanced degree (e.g., MBA) preferred
- Specialist: 2–4 years of relevant experience
- Manager: 3–5+ years of relevant experience
- Prior experience in pharmaceutical, biotech, or related industry strongly preferred
Core Competencies
- Strong project management and organizational skills
- Demonstrated ability to collaborate across cross-functional teams
- Ability to translate insights and data into actionable execution
- Self-starter with strong ownership mindset and ability to manage multiple priorities
Technical Skills
- High proficiency in Microsoft Office (Excel, PowerPoint)
- Experience with SharePoint and Microsoft Teams required
- Familiarity with financial systems (e.g., Ariba/eMP) preferred
- Ability to quickly learn internal systems (e.g., WESS)
Preferred Experience
- Background in Clinical Operations (ClinOps) or Medical Affairs operations
- Experience with CME coordination and/or IIS processes
- Exposure to budget tracking and financial planning
- Certifications such as PMP, Six Sigma (Green Belt), or change management (e.g., Prosci) are a plus
Soft Skills
- Strong communication (written and verbal) and stakeholder management skills
- Comfortable working in a fast-paced, evolving environment
- Proactive problem-solver with critical thinking capabilities
- Ability to operate independently with minimal supervision after onboarding
