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Job Details

Technical Communications Specialist

Company name
Smith & Nephew.

Location
Lawrence, MA

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Profile

ABOUT US

  Smith & Nephew supports healthcare professionals in  more than 100 countries

 in their daily efforts to improve the lives of their patients.  We do this by taking a  pioneering approach

 to the design of our  advanced medical products and services

, by securing wider access to our diverse technologies for more customers globally, and by enabling better outcomes for patients and healthcare systems.

We have leadership positions in:

Orthopaedics Reconstruction - joint replacement systems for knees, hips and shoulders

Advanced Wound Management - wound care treatment and prevention products used to treat hard-to-heal wounds

Sports Medicine - minimally invasive surgery of the joint

Trauma & Extremities - products that help repair broken bones

  We have around  15,000 employees

 around the world.  Annual sales in 2016 were more than $4.6 billion

.  We are a constituent of the UK's FTSE100 and our shares are  traded on the London Stock Exchange

 and through  American Depository Receipts on the New York Stock Exchange

 (LSE: SN, NYSE: SNN)

SUMMARY

Under a high level of management supervision and direction, coordinates all labeling generation tasks with respect to internal system(s) and regulatory requirements. Provides support for change control tasks.

ESSENTIAL FUNCTIONS

  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 guidance’s/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.

Job Requirements

REQUIREMENTS

Travel 0-25% (may frequently involve overnight and/or multi-day travel)

Education      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       N/A

Experience    Prior demonstrated experience in desktop publishing preferred

Competencies          •           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.

Other  •           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

  Smith and Nephew is an Equal Opportunity/Affirmative Action Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by applicable law.

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Company info

Smith & Nephew.
Website : http://www.smith-nephew.com

Company Profile
The Group has a history dating back 160 years to the family enterprise of Thomas James Smith who opened a small pharmacy in Hull, England in 1856. On his death in 1896, his nephew Horatio Nelson Smith took over the management of the business.A few days after the declaration of World War 1 in 1914, Horatio Nelson Smith (the nephew of the company founder T. J Smith) met with an envoy of the French President in London. The company was awarded a contract to supply £350,000 of surgical and field dressings, to be delivered in five months. By the late 1990s, Smith & Nephew had expanded into being a diverse healthcare conglomerate with operations across the globe, including various medical devices, personal care products and traditional and pioneering woundcare treatments. In 1998, Smith & Nephew announced a major restructuring to focus management attention and investment on three business units — wound management, endoscopy and orthopaedics— which offered high growth and margin opportunities.

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