GPE Document Associate

GPE Document Associate

Global Pharmacovigilance and Epidemiology

 

Cephalon is a place to think big.  It’s a work environment that challenges sharp minds, values an eye for opportunity and satisfies the motivation to make a positive impact.  The success of the company today reflects a collective ability to spot unexpected opportunities and the courage to waste no time in seizing them.  It’s a place where confidence is valued, independence is encouraged and agility is rewarded.

 

Position Summary:

The Document Associate is responsible for the maintenance and tracking of GPE procedural documents (i.e., policies, standards, global standard operating procedures (SOPs), working instructions, and pharmacovigilance (PV) system manuals.  This position is also responsible for assisting in instructor lead training as directed by the Training Manager.  This position will collaborate with the GPE Compliance and QC functions to address process needs and/ or corrective actions.  The document associate will act as administer for the learning management system (LMS) and provide assistance in preparation and facilitation of any regulatory authority inspections.  Success in this position is predicated on strong negotiation and project management skills, as well as a commitment to teamwork.

 

Qualifications:

·  Bachelor’s degree in science or healthcare related field with 2 - 3 years experience in drug safety, advanced degree preferred

·  One year of medical or regulatory writing

·  Ability to work independently and in a team is essential

·  Ability to travel domestically and internationally

·  Working knowledge of FDA and international regulations

·  Excellent communication and project management skills

·  Computer skills to include Microsoft Office, Excel and Project

 

 

For immediate consideration, please apply to:  http://www.applyforjobsnow.com/afjn/jobboard/Redirect.aspx?__JobID=553