OneTrust

Manager, Regulatory Policy Research

OneTrust

full-time

Posted on:

Location Type: Hybrid

Location: Raritan • District of Columbia • New Jersey • United States

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Salary

💰 $102,000 - $177,100 per year

About the role

  • Conduct scientific and policy research to support GRPI and GRA initiatives, positions, and ad-hoc queries
  • Deliver comprehensive research and policy resources to GRPI leaders and policy leads
  • Provide regulatory intelligence support to GRPI and GRA, ensuring that the team provides timely and relevant insights
  • Coordinate and manage training programs related to regulatory intelligence
  • Conduct research for various outputs including publications, presentations, and policy positions
  • Ensure research activities align with organizational goals and regulatory requirements
  • Create and implement tools to support policy priorities, strategic plans, and other policy documents
  • Identify opportunities to use technologies to simplify policy team processes and approaches
  • Develop, implement, and drive adoption of technology tools to support policy priority-setting and strategic planning
  • Manage cross-functional participation in commenting tools, ensuring proper document retention, archived guidances, and user support
  • Support development and maintenance of the GRPI website and related tools
  • Support the policy team’s coverage of trade association policy activities and other external policy groups as needed
  • Track and report on trade association policy activities and external policy group engagements
  • Partner with policy leads to plan and execute regulatory policy workshops on high-priority policy topics
  • Provide support related to consultant purchase orders and invoices, ensuring timely payment and accurate recordkeeping

Requirements

  • A minimum of a Bachelor’s degree in a scientific or technical discipline
  • An advanced degree (Master’s, PharmD, Ph.D.) in a scientific or technical discipline is preferred
  • A minimum of 4 years of experience in the pharmaceutical industry or Contract Research Organization (CRO) is required
  • A minimum of 2 years of experience in Regulatory Affairs Policy support is required
  • Experience working at a major health authority (e.g., FDA) is preferred
  • Solid understanding of the global regulatory environment, including the U.S., European Union and Asia Pacific, is preferred
  • Understanding of global regulatory systems is preferred
  • Knowledge of healthcare policy landscapes is preferred
  • Experience with digital health and/or artificial intelligence (AI) is preferred
  • Familiarity with regulatory intelligence platforms and collaboration tools (e.g., Citeline, Cortellis, SharePoint, Power BI, Teams) is required
  • Strong computer skills, with the ability to work with programs such as Smartsheet and SharePoint, required
  • Must have excellent oral and written communication skills
  • Must have strong negotiation and stakeholder management skills
  • The ability to manage multiple priorities and work cross-functionally in a global, matrixed environment
Benefits
  • medical, dental, vision, life insurance
  • short- and long-term disability
  • business accident insurance
  • group legal insurance
  • consolidated retirement plan (pension)
  • savings plan (401(k))
  • vacation - up to 120 hours per calendar year
  • sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
  • holiday pay, including Floating Holidays - up to 13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory affairsscientific researchpolicy researchregulatory intelligencedigital healthartificial intelligenceglobal regulatory environmenthealthcare policycross-functional managementrecordkeeping
Soft Skills
oral communicationwritten communicationnegotiationstakeholder managementprioritizationorganizational skillsteam collaborationtraining coordinationstrategic planningproblem-solving