We are looking for a Global Regulatory Affairs Process Consultant to analyze and design / redesign existing business processes in collaboration with key functional stakeholders and subject matter experts for a global biotechnology organization.
We are looking for someone who can hit the ground running in this role to reduce process complexity, increase process efficiency and increase process effectiveness.
· Utilize functional expertise to assess current-state processes and identification of potential areas for improvement which will focus on efficiency, compliance and lean methods
· Assist with the process analysis and process recommendations that will drive greater productivity and maintain compliance
· Work with client functional team members to understand current-state processes and outcomes.
· Participate in functional-specific and cross-functional meetings (those focused on incremental improvements) in order to share ideas and discuss opportunities
· Partner with business leaders to maintain ongoing communication regarding improvement opportunities and discuss change management
· Organize and communicate data in a manner that conveys a succinct and compelling concept
· Plan, manage, and execute small to medium size process improvement initiatives
Skills and Qualifications
· Requires a 4-year college degree, advanced degree preferred
· 15-20+ years of Pharmaceutical / Biotechnology company experience with a demonstrated history of progression within a functional discipline (i.e. clinical operations, data management, pharmacovigilance, reg. affairs, etc)
· Previous consulting experience preferred
· Must have worked in a Global Sponsor company environment and proficient with SOPs, process and with external and internal functional stakeholders
· Process Certifications (LEAN, ITIL or equivalent) a plus
· Experience working in a team environment; preferably in a professional environment
· Applicable work experience in a consulting or contact center environment
· Excellent communication skills including research, writing, and presentation skills
· Ability to form and maintain cross-functional relationships