Job Summary
Ensures all content for product labeling, Instructions for Use, and equipment manuals meet all required legal, regulatory, clinical, marketing, packaging, manufacturing (contract and internal) and R&D requirements through the use of corporate labeling guidelines and SOPs.
Job Description
Responsibilities
• Handles requests for development, reviews, and changes of all product labeling.
• Design labeling materials according to specific parameters to meet the requirements of the corporate master brand (labels, Instructions for Use artwork/layout, etc.)
• Establishes needs for translations as defined in the marketing/product specifications and manages the process for translation completions and reviews for project assigned.
• Coordinates proofing of various Labeling materials (Instructions for Use, Manuals, and Labels) using manual and electronic proofing tools.
• Coordinates reviews with all disciplines of various product labeling materials and maintains product labeling files.
• Manages multiple projects concurrently, while complying with good manufacturing practices (GMPs), regulatory, quality systems standards and labeling requirements.
• Develops Labeling component specifications.
• Provide graphics/labeling support to other departments as required.
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Qualifications
• Degree or equivalent
• 3+ years of experience in medical device / pharma industry with relevant requirements experience developing artwork and graphics for regulated medical device or drug products and creation and management of design changes in an electronic environment.
• Experience utilizing computer-aided design equipment and/or graphic tools such as Adobe CC.
• Experience with in-house, on-demand labeling system such as Prisym, BarTender and JetMark.
• Flexibility to accommodate and manage changing priorities, deadlines, and project needs.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
Company Description
CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.
CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com .
CooperSurgical
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