The Regulatory Program Support Manager will support projects related to collection of data on health and safety of Source Plasma donors and recipients of plasma protein therapies and other regulatory-related projects. 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.
Send cover letter, resume and salary requirements to:
PPTA Human Resources Attn: Cathy Izzi email@example.com
Minimum BS degree, Masters of Public Health, or MPH candidate, or MS in health-related field preferred
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
About Plasma Protein Therapeutices Association
The Plasma Protein Therapeutics Association (PPTA) is the primary advocate for the world's leading producers of plasma-based and recombinant biological therapeutics. The medicines produced by PPTA members are used in treating life-threatening diseases and serious medical conditions including bleeding disorders, immune system deficiencies, burns and shock.
As the global representative for the plasma therapeutics industry, PPTA works cooperatively with patient groups, legislators, regulatory agencies and others to address critical issues that impact the industry and those people who depend on plasma protein therapeutics. PPTA's strength lies in its membership. The Association's global committees and regional working groups bring together industry experts to focus on important issues relating to the quality, safety and efficacy of plasma therapeutics.