Directs and coordinates activities concerned with lifecycle management of existing marketed products in order to ensure compliance with regulations and business continuity. Manages the activities for the timely and efficient execution of several interrelated processes (PPRR, PSUR, CER, PMCF) necessary to deliver periodic updates to notified bodies, updates to product labeling and Summary Technical Documents (STeD), and required safety updates to the general public. Works with wide latitude for unreviewed action or decision and represents all aspects of the Post-Production Lifecycle Management (PPLM) process to the broader organization. Provides primary direction on process and governance related matters to all stakeholders and subject matter experts who participate in the process.
Manage the overall PPLM process and schedule for all relevant technical reports (PPRR, PSUR, CER, PMCF, SSCP, STeD, etc.) in collaboration with key functional stakeholders across the company
Responsible for implementation of the strategy as it relates to maintenance of post-production lifecycle management. Liaises with other areas of the business providing senior input and advice to global projects.
Utilizes project management and process excellence expertise to support strategies, core processes, and enterprise tools which significantly contribute to organizational objectives.
Provides regular status updates and escalates risks/issues impacting technical report submission (PPRR, PSUR, CER, PMCF, SSCP, STeD) to PPM Leaders
Provide regular status reports and dashboards across key functional areas to inform of overall schedule status, risks and issues.
Establish and manage R&D digital data library and maintain regular checkpoint meetings with teams
Assure continuity of products, processes and compliance with both internal policy and external regulations pertaining to post-production lifecycle management.
Provides leadership direction, determining and developing approach to solutions by coordinating multiple resources to solve complex problems.
Bachelor's Degree or Equivalent years of directly related experience (or high school+15 yrs; Assoc.
11 yrs; M.S.
4 yrs; PhD+3 yrs)
The ability to fluently read, write, understand and communicate in English
7 Years of Relevant Experience
Ability to prioritize and manage multiple projects/initiatives in a timely and cost effective manner
Proven ability to motivate, manage, and develop innovative cross-functional project teams composed of scientific and technical personnel
Excellent analytical and communication skills (verbal and written)
Proven ability to perform independently
Project Management Professional Certification (preferred) Medical Device Experience (preferred)
Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.