Regulatory Operations Specialists

Location: North Wales, Pennsylvania
Posted On: 5/8/2017
Job Code: 2784-ROS-PA
Job Description
This position will be responsible for working directly with vendors selected for Regulatory Content Management (RCM) and Global Submissions Publishing (GSP) activities within Global Regulatory Affairs and Clinical Safety (GRACS) to manage a transition in external partner relationships with vendor based in India. The role will focus on the transition of currently outsourced Publishing Workload to new vendors. The selected project manager will work collaboratively with internal and external partners to establish a transition plan including the development of a training plan and relevant job aids. This role will work seamlessly with colleagues in GRACS External Operations to ensure the transition within Global Submissions Publishing is executed effectively. Responsibilities will include project management and oversight of transition deliverables and timeliness including training documentation.
Category:IT  code:new
Job Requirements
Solid knowledge and experience in Regulatory Publishing
Effective management and organizational skills to efficiently manage multiple vendor transitions
Minimum of 6 years experience within the healthcare/consumer care industry, regulatory affairs or pharmacovigilance function that includes working with external partners
Minimum of 3 years project management or oversight experience
Knowledge of drug development, specifically regulatory, CMC, and global safety processes for pharmaceutical products, vaccines and/or biologic products
The selected candidate will require a working knowledge of regulatory publishing, outsourcing, and supplier management with a strong track record of demonstrated leadership and capability with managing a transition to an external vendor

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Contact Details
Kajal Batrani
E-mail Address