Global Labeling Specialist II
Global Labeling Specialist II
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Salary Not Disclosed
1 Vacancy
Job Description
About CooperSurgical
CooperSurgical is a leading fertility and womens 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 womens healthcare providers including testing and treatment options.
CooperSurgical is a whollyowned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical headquartered in Trumbull CT produces and markets a wide array of products and services for use by womens health care clinicians. More information can be found at
Responsibilities for Internal Candidates
Handles requests for development reviews and changes of all product labeling.
- 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.
- 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 andmaintains 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.
Responsibilities
Handles requests for development reviews and changes of all product labeling.
- 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.
- 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 andmaintains 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 computeraided design equipment and/or graphic tools such as Adobe CC.
- Experience with inhouse ondemand 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 fastpaced changing environment.
As an employee of CooperSurgical youll 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 atcomto 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 viaemail 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.
Required Experience:
Exec
Employment Type
Full-Time
