Manage quality control processes within content approval including ABPI examination and certification
Identify, assess, and execute/manage actions to mitigate risks associated with content approval operations
Review and identify trends from reports on quality performance, compliance status, operational effectiveness and improvement initiatives
Engage with GMI CA Leadership, team members and key business partners identifying opportunities for continuous improvements
Assist as a subject matter expert on content approval process, serve as a key point of contact for audits and inspections, and manage remediation efforts related to content approval
Develop and implement robust content approval management monitoring and ensure timely completion of relevant CAPAs
Act as the deputy global process owner for the process of approval of promotional and non-promotional materials
Identify training needs and develop and deliver a comprehensive training strategy for Content Approval team members
Partner with ABPI Directors, GMI&CA leadership and internal stakeholders to ensure training content remains current and relevant
Requirements
Master’s/Graduate Degree in Life Sciences or Healthcare
6+ years of pharmaceutical industry experience
3+ years of Medical Affairs experience
Strong understanding of content approval requirements including external regulations (e.g. ABPI Code)
Experience in quality and compliance oversight including audits and inspections
Experience in the development and delivery of training and onboarding programs