Consultant, Real World Regulatory Science and Strategy

at  IQVIA

Remote, Oregon, USA -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate19 Nov, 2024USD 189400 Annual21 Aug, 2024N/AData Quality,Epidemiology,Project Management Skills,Knowledge Base,Regulatory AffairsNoNo
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Description:

Desired Qualifications

  • Advanced degree required (Master’s, PhD, etc.) concentration in Epidemiology, Regulatory Affairs/Science, or other applicable life sciences focus preferred.
  • Master’s degree + 3 or more years of experience.
  • PhD, ScD + 1 or more years of experience.
  • Professional experience in scientific consulting or delivering US real world regulatory studies; must have an understanding of the implications of FDA regulations and guidances on real world studies.
  • Strong knowledge base in data quality, real world data, and epidemiologic principles.
  • Strong project management skills.
  • Ability to thrive in scientific ambiguity or “white space”.
  • Skilled in collaborating with cross functional internal and external groups.
  • Ability to manage multiple projects, juggling priorities and delivering on tight deadlines.
  • Excellent presentation, communication and client facing skills

Responsibilities:

  • Participates in the regulatory strategy related to the design, development, and delivery of real-world studies.
  • Collaborates on innovative and challenging topics in life sciences: regulatory science is the field of supporting life sciences clients with novel approaches to drug, biologic, and medtech product development.
  • Supports the development and thought leadership of fit-for-purpose frameworks for real-world data sources.
  • Reviews real-world protocols and real-world data sources to evaluate alignment with FDA and other regulatory guidelines.
  • Designs, develops, and delivers client reports and presentations.
  • When acting as Project Manager, proactively manages project timelines and manages day to day communication with the client and team members.

Desired Qualifications

  • Advanced degree required (Master’s, PhD, etc.) concentration in Epidemiology, Regulatory Affairs/Science, or other applicable life sciences focus preferred.
  • Master’s degree + 3 or more years of experience.
  • PhD, ScD + 1 or more years of experience.
  • Professional experience in scientific consulting or delivering US real world regulatory studies; must have an understanding of the implications of FDA regulations and guidances on real world studies.
  • Strong knowledge base in data quality, real world data, and epidemiologic principles.
  • Strong project management skills.
  • Ability to thrive in scientific ambiguity or “white space”.
  • Skilled in collaborating with cross functional internal and external groups.
  • Ability to manage multiple projects, juggling priorities and delivering on tight deadlines.
  • Excellent presentation, communication and client facing skills.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
The potential base pay range for this role, when annualized, is $113,600.00 - $189,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Proficient

1

Remote, USA