Project Manager

Strong candidate with 10+ years' experience coordinating efforts related to the planning, oversight and management of projects on Regulatory Information Management systems and Pharma/Biotech Drug Manufacturing Process .

• Project Manager will work closely with the QA and Regulatory teams and representatives from other functional groups (R&D, Software, Manufacturing and Supply Chain) to manage development and implementation of new processes, procedures, and work flows, as well as ongoing review and oversight processes to support compliance.
• Strong competencies in planning, project management, and organization with the ability to lead multiple activities and resources while maintaining a focus on quality.
• Document and manage project risks, issues and action items and document actions necessary to mitigate risks
• Manage the documentation processes associated with the in scope projects, including the creation and execution of the Change Control(s).
• Candidates will possess independent work habits, strong organizational skills, enhanced attention to detail, diplomacy, and extensive written and verbal communications skills.

Demonstrated proficiency in Microsoft applications (Word, Excel and PowerPoint). Need advanced Excel abilities. An understanding of Databases is a plus.