Regulatory Program Support Manager

Employer
PPTA
Location
Annapolis, Maryland
Posted
Mar 03, 2018
Closes
Apr 07, 2018
Industry
Associations
Hours
Full Time

Plasma Protein Therapeutics Association, a biopharmaceutical trade association, seeks a Regulatory Program Support Manager to support projects related to collection of data on health and safety of Source Plasma donors and recipients of plasma protein therapies and other regulatory initiatives. Responsibilities include, but are not limited to, scientific literature research; summarizing and indexing information on selected topic areas; assisting with industry data analysis relating to donor and patient health; working with and communicating research findings to relevant PPTA staff; preparing study protocols, IRB submissions, research documentation and PowerPoint presentations; and assisting in development of manuscripts for publication.

Qualifications:

Education

  • Minimum BS degree, Masters of Public Health, or MPH candidate, or MS in health-related field preferred

Experience

  • Experience in performing health related literature research, review, analysis, and indexing (database)
  • At least two years’ experience in managing epidemiology studies or clinical research
  • At least one year of experience in analysis of epidemiological or health related data
  • Must have basic biostatistical course work and skills

Skills & Abilities

  • Proficiency with Microsoft Office products, especially Excel and PowerPoint
  • Working knowledge of PubMed online database and literature management software
  • Ability to work both in team environment and independently
  • Excellent written and verbal communication skills
  • Experience with data management and analysis software packages desirable
  • Experience with Tarius or other regulatory intelligence service desirable

Send cover letter, resume and salary requirements to:

Cathy Izzi
Human Resources
cizzi@pptaglobal.org

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