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At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health

 

What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.

 

None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.

 

While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.


The Product Labeling Associate will:


  • Oversee the creation, approval and execution of product labeling, adhering to corporate and branding guidelines, to support existing and new products both domestically and internationally.
  • Maintain branding guidelines for product labeling
  • Coordinates translation activities with approved translation services
  • Ensures proper approval is received on new and revised labeling
  • Interfaces with other Hologic functions to ensure proper support is applied to development, approval, and implementation of labeling
  • Communicates with Purchasing, Marketing, Engineering, Quality Assurance and Regulatory Affairs to assure delivery of requested deliverables to meet specifications
  • Perform necessary release and change order activities to ensure proper approval and implementation of Labeling, including structuring into product configurations
  • Partner with Project Manager to understand timelines for required product labeling 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the basic knowledge, skills, and/or abilities required.


  • Demonstrated proficiency in use of various desktop publishing applications such as Adobe Acrobat, Photoshop, Illustrator, Quark Xpress, and FrameMaker as well as Microsoft Office products
  • Understanding of Standard Operating Procedures specific to product labeling
  • Excellent written and verbal communication skills
  • Understanding of Documentation Control systems and regulations, Agile preferred

Education

 

B.S. degree or B.A degree preferred or equivalent experience

 
 
Experience 
  • 3-5 years experience in the development of product labeling
  • Has interfaced with Marketing, outside vendors, Engineering and Science Personnel
  • Experience in an FDA Regulated environment, preferably with respect to the release of labeling
  • Experience with translation activities 

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter.  All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

 

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.


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