Global Regulatory Affairs Project Manager

Be your best, join the best.

PRA International strives to be the best clinical development organization in the world.
We work with many of the best and brightest in the world’s pharma and biotech industries. And we have locations across the continents and projects across the therapeutic spectrum.

We need colleagues who can meet our challenge of excellence and integrity. We need people who want to put their degrees to work. Real work that speaks to the future as well as the present. And in return we offer real compensation, benefit and bonus opportunities, and continuing development programs.

Our Global Requlatory Project Manager will assist senior regulatory staff in the preparation and review of regulatory submissions, for internal customers or external clients. Primary job responsibilities include the preparation of global regulatory submissions to support the initiation of clinical trials for investigational drugs, biologicals, or medical devices. May participate in internal project teams and may lead specific regulatory tasks, under the guidance of senior staff. May assume responsibility for direct communication of project specifics to external client upon the approval of senior staff.

ACCOUNTABILITIES
1.Interacts with internal clients. May have some limited external interactions when directed by senior staff.
2.Supports senior staff in managing client requests.
3.Tracks project timelines and implements client requests with senior review.
4.Assists in preparation of clinical trials submissions to support key study start up activities within the PRA environment.
5.May make decisions on or develop new processes for specific tasks, consulting senior staff, as necessary.
6.Keeps abreast of current data, trends, regulatory knowledge, developments and advances in area of expertise.
REQUIREMENTS
Requirements:
•Must have careful attention to detail and accuracy.
•Must be able to collaborate with others and provide independent thought to improve processes.
•Working knowledge of regulations relevant to the area of expertise.
•Ability to communicate effectively in both oral and written modes.
•Ability to work on several projects at once while balancing multiple timelines (ie, overlapping timelines on one or more projects).
•Ability to assess workload and suggest prioritization to senior staff.
•Must be computer literate.


PRA offers a highly competitive salary, full benefits, talented professional colleagues, and real growth opportunity in a technologically advanced workplace.
To apply, please go to http://www.prainternational.com