Technical Writer

Title: Technical Writer

Location: 5050 Nathan Lane N. Plymouth MN USA 55442

Duration: 12 Months

100% Onsite

RESPONSIBILITIES

• Creates and modifies labeling for product labels, cartons and other related materials ensuring that they meet all medical, legal, and regulatory requirements for medical devices following the established design format, labeling style guidelines, and branding guidelines.
• Supports a cross-functional team collecting labeling content and translating it into functional label layouts utilizing labeling software. Mostly works on commercialized product labels.
• Works with other functions to identify and resolve labeling inconsistencies with labeling material and requirements and to meet project objectives.
• Creates and manages labeling change requests within the document management system.
• Designs product labeling considering such factors as product identification, worldwide requirements, sales appeal, aesthetic quality, printing, and production techniques.
• Schedule/deadline provided for assigned work/tasks.
• Maintains knowledge of new developments in packaging and labeling technologies.
• Manages multiple concurrent deadlines.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Education Level

• Bachelor’s Degree in any field. (± 16 years)

Experience/Background

• Minimum 1 year in a similar capacity and/or med device.

Experience Details

• Working with product labeling, design dossiers, quality systems, and/or regulatory labeling.
• Required experience developing artwork and graphics for FDA regulated medical products and creation and management of change requests in an electronic environment.
• Experience utilizing computer-aided design equipment and/or graphic tools such as, CAD, Adobe Illustrator/Photoshop, and other related software
• Ability to schedule and organize multiple projects
• Ability to communicate effectively with internal and external customers and team members
• Thorough knowledge of FDA, GMP, and ISO guidelines
• Requires ability to be innovative, resourceful, and work with minimal direction.
• Requires excellent organization, problem solving, and communication skills and the ability to work effectively with cross-functional teams
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes, and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.