Share this Job

 

 

 

 

Title:  Labeling and Technical Writing Specialist

Requisition Number: 
Description: 

 

Enable Injections is made up of a team passionate about working together to make people’s lives better. We develop, manufacture, and support the enFuse®, a platform of wearable infusion devices designed to enable subcutaneous self-administration of high-volume therapeutics. Enable employees are technology experts focused on an exceptional patient experience in collaboration with our biopharma partners.

 

SUPERVISOR’S TITLE: Manager, PD

 

 

PURPOSE OF POSITION: With limited support and coaching, the Labeling and Technical Writing Specialist, Product Development will provide support to the Product Development department in the management of medical device labeling and technical documents throughout the design control process to commercialization.

 

QUALIFICATIONS

 

 

Required:

  • Vocational training in technical writing, English, science, marketing, regulatory, or quality assurance​​​​; OR equivalent combination of education and experience.
  • Detail-oriented with a strong desire to perform technical writing and documentation.
  • Ability to self-manage, solicit input from multiple departments and execute on multiple tasks.

 

Preferred:

  • Experience with medical devices or other regulated product.
  • 5 years of work in a regulated environment.
  • Associates Degree minimum.
  • Experience working in technical environment with technical personnel.
  • Experience generating technical documentation and product labeling.
  • Ability to lead meetings and drive toward decisions.
  • Proficiency in SAP or other product lifecycle management software

Skills & Competencies:

  • Strong organizational skills.
  • Excellent verbal communication and technical writing skills.
  • Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook).
  • Proficiency in the use of SAP for document changes.
  • Able to understand product drawings and label layouts.
  • Able to lead meetings by setting agendas, driving decisions, and documenting minutes.
  • Able to interface with external partners to determine project needs.
  • Demonstrated ability to prioritize tasks and lead a varied workload to meet team objectives.

 

 

Physical Requirements:

  • Must be able to remain in a stationary position for extended periods of time
  • Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.

RESPONSIBILITIES:

  • Own all labeling creation and changes for the EnFuse products.
  • Determine required labeling changes by soliciting input from appropriate departments and personnel.
  • Generate protocols, reports, technical rationales, standard operating procedures, and other design control documents based on input from a cross-functional team.
  • Support the product development engineers and interface with label suppliers to determine label requirements.
  • Collaborate with Product Managers to gain understanding of Partner labeling needs.
  • Coordinate with regulatory to implement labeling standards.

 

 

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.  


Nearest Major Market: Cincinnati