Under general management supervision and direction, coordinates all labeling generation tasks with respect to internal system(s) and regulatory requirements.
Provides support for change control tasks.
Coordinates and generates final layout and translation of all product labeling, including IFUs (Instructions for Use), in accordance with recognized labeling standards or other relevant regulatory guidances / regulations.
Routes for approval, implements and / or archives labeling documentation using approved internal change notice system (ECN or the like).
Maintains ongoing communication with internal (e.g. Regulatory Affairs, Operations, Quality, Product Development Teams, Marketing, etc.
and external stakeholders (e.g. labeling and translation vendors) to achieve labeling goals / tasks.
Periodically assesses labeling system and manages needed modifications as the company evolves.
0-25% (may frequently involve overnight and / or multi-day travel)
Requires a Bachelor’s Degree (preferably a clinical, medical, scientific / technical, desktop publishing, graphic design, English or legal degree) or equivalent in education or experience.
Licenses / Certifications
Prior demonstrated experience in desktop publishing preferred
Requires a high level of computer proficiency (Adobe, MS Office, SAP, etc.) with experience in label generation and desktop publication / layout software preferred.
Possesses appropriate verbal and written communication skills for interacting with internal and external stakeholders.
Demonstrates a solid, fundamental understanding of medical terminology, anatomy, regulations, standards and technical concepts.
Able to work and problem solve both independently and as part of a team.
Able to work within deadlines as imposed by government regulations and internal guidelines.
Able to handle multiple tasks / projects and demonstrate flexibility in managing changing priorities.
Able to read, understand, and apply regulations to activities.
Knows and adheres to the quality policy of the company and the quality-related procedures and instructions
Reports any deviation in product or process, of which he / she becomes aware, to his / her manager or the Quality department
Completes all necessary training in the area of Quality and GMP (Good Manufacturing Practice)
Immediately reports any dissatisfaction or complaint which is brought to their attention from a customer or patient regarding a Smith & Nephew product (e.
g. in terms of quality, durability, reliability, safety or performance) to the complaints department
Complies with all health, safety and environmental policies, procedures and job hazard analyses applicable to specified job activities;
including medical evaluations as required by job function
Completes all required HSE training
Physical Demands :
Weight Lifting : Mostly light (0kg - 5kg)
Position : Mostly sitting
Repetitive Motion : Mostly computer use
Chemical Exposure : No chemicals exposure or cleaning use only
Physical Risk (Personal Protective Equipment PPE) : No PPE required