Sr. Content Specialist

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon.  As a Sr. Content Specialist, you will lead and oversee the strategic and operational aspects of regulatory labeling for medical devices and pharmaceutical products. This role is essential in ensuring that all labeling activities comply with international regulations and standards, while effectively managing labeling content and artwork approvals. The position is responsible for advancing regulatory labeling practices, enhancing labeling processes, and integrating technology to streamline future operations at the Fort Worth (Main Facility), TX, USA

In this role, a typical day will include:

• Coordinates Master Labeling Content review and approval for new and revised content. 

• Supports the GRA strategist (Project/Product owner) on required content changes and executes revisions to Master Labeling Content document. 

• Coordinates with Labeling Head and stakeholders to ensure consistency across product labeling and incorporate updated /revised global and /or country specific labeling requirements. For products with updated Master Labeling Content, reviews and approves revisions to labeling components.

• Provides input to regulatory assessments and change request bundling evaluations for labeling and coordinates GRA strategist to complete RIARS. 

• Initiates portfolio-wide label change requests based on regulatory intelligence and other external input. Propagates labeling requirements knowledge sharing in functions beyond GRA.

• Regulatory Labeling Compliance: Develop and implement labeling strategies to ensure compliance with global medical device regulations and standards, including FDA, CE Marking, Health Canada and ISO.

• Content and Artwork Management: Oversee the management, review, and approval of Medical Device Labeling Content and artwork for various products, ensuring regulatory and internal compliance.

• Regulatory Objectives Support: Support regulatory objectives such as Post-Production Risk Reviews (PPRR), Risk Management Report (RMR), Clinical Evaluation Report (CER), labeling gap assessments, and labeling technical documentation.

• Regulatory Harmonization: Manage and implement harmonization activities to ensure consistent labeling across different markets and handle variations in response to unique local/regional requirements and regulatory changes.

• Technology Integration: Lead efforts to integrate advanced technologies and automation solutions to enhance labeling processes and operational efficiency.

• Continuous Improvement: Drive continuous improvement initiatives to optimize labeling processes, increase efficiency, and ensure regulatory compliance.

• Expertise and Training: Provide expertise in regulatory standards, mentor team members, and stay current with industry trends and regulatory changes.

WHAT YOU'LL BRING TO ALCON:

• Bachelor’s Degree in Life Sciences (e.g., Biology, Chemistry, Biomedical engineering, etc.) or Equivalent years of directly related experience (Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)

• The ability to fluently read, write, understand and communicate in English

• 5 Years of Relevant Experience

• Work hours: 40hours

• Travel Requirements: 10% or less

• Relocation assistance: No

• Sponsorship available: No

Nice to Have (Preferred experience, skills, and abilities):

• Deep understanding of global medical device regulations including: FDA21 CFR part 801, European MDR/IVDR, and other labeling standards

• Familiarity with ISO standards related to labeling such as ISO 20417, ISO 15223-1, and ISO 13485

• Knowledge of labeling requirements across major markets including, US, EU, and Canada

• Ability to think strategically, navigate ambiguity, and decision-making

ATTENTI