Summary:

• Public Affairs & Access is a multi-disciplinary organization that includes Corporate Communications, Policy, Evidence, & Access Strategy, Channel & Contract Management, External Affairs, and Strategy & Business Operations. Our purpose is to amplify our data and evidence generation to support and accelerate access for eligible patients.
• Within the Strategy & Business Operations Team, the Policy, Evidence, & Access Strategy (PEAS) Operations, is accountable for developing customer-centric solutions that bridge operational excellence with the business strategy of the PEAS Function. Inclusive of providing:
• Through partnership and core functional operations
• Strategic project and change management support
• Vendor contracting and research operationalization
• Compliance and risk mitigation efforts

Key Responsibilities:

• Develop and maintain an understanding of the types of research the Evidence for Access (E4A) organization executes, including operational considerations specific to the types of research conducted by the E4A organization (real-world data studies, health economics and outcomes research, health systems research, non-interventional studies, etc.).
• Develop and maintain a sound understanding of compliance, legal, and regulatory frameworks that underpin related policies and practices that apply to E4A deliverables (e.g., non-interventional study requirements, research collaboration decision-making, etc.).
• Partner with researchers on E4A research projects during the project planning, execution, and application phases to enable successful delivery and pull-through of evidence.
• Work directly with the appropriate internal company’s functions (e.g. Safety, Compliance, Medical, Global Process Owners, etc.) to ensure E4A maintains compliance with all applicable processes and has efficient, fit-for-purpose approaches in place for E4A-related activities.
• Engage with research collaborators and external vendors as required to facilitate contract negotiation and finalization, manage project issue escalation between parties, etc.
• Contribute to a team culture of innovation, enterprise-level thinking, collaboration, and impact.

Qualifications and Experience

• Bachelor’s Degree required
• At least 3 years of relevant experience in operations or similar roles with transferable skills. Prior work experience in research & development (early or late phase), medical affairs, or in support of clinical or non-clinical study teams is preferred.
• Foundational knowledge of key project management concepts used across a project lifecycle and prior experience applying some of these concepts in a work setting.
• Technical proficiency with software and platforms including but not limited to MS Word, Excel, PowerPoint, gSuite tools (Doc, Sheets, Slides, Meet, Visual Basic, Analytics, etc.), and internal global systems (CTMS, MDMS), etc.
• Foundational knowledge of the U.S. healthcare system and marketplace – including familiarity with concepts relating to health economics, health services research, pharmaceutical research, and development cycle, real-world evidence, value assessment, drug information, drug commercialization, and payer and formulary processes.
• Ability to travel for ad hoc internal and external meetings as required

Skills / Abilities:

• Excellent organizational, interpersonal, written and verbal communication
• Proven track record of working effectively in a collaborative, fast-paced, deadline-driven environment
• Must be able to multitask with strong attention to detail and be adaptable to change with minimal oversight
• Excellent problem-solving and planning skills, with a focus on quality and accuracy
• Team player with an eagerness to learn and adapt to business needs
• Commitment to quality with Impeccable ethics and integrity

The hiring range for this position is $77 to $87 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on the candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.

#ZR