ERT

Director, Translations

Job Location US-MA-Medford | US-PA-Pittsburgh
Shift
FT/Reg
Type
Regular Full-Time

Overview

Join ERT as Director, Translations, and provide organizational support and operational delivery fulfilment as it relates to translations implementation and copyrighted instrument licensing for all lines of business. Ties together licensing compliance of both translated and also English copyrighted instruments to allow for opportunities to manage additional service offerings including translations linguistic validation of instruments, licensing procurement, instrument support, and instrument sub-licensing programs.  In addition, this role includes providing ownership and oversight of the creation of a standard component library for design, development and translations supported by automated tests.  The standard components may include but are not limited to eCOA study artifacts such as common device functionality, standard solutions and standardized assessments.

 

ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so we can adapt without compromising standards.


Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more than three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly — and with confidence.

Responsibilities

In this role you will:

  • Oversee translations implementation of products and associated materials, linguistic validation, instrument licensing procurement, and general instrument support across eCOA, Respiratory, and Cardiac Safety lines of business.
  • Be responsible for oversight and support of standard library development and deployment.
  • Manage the global Translations and Instrument Support teams and Standardization resources with a focus on quality and timely delivery of projects related to these functions.
  • Coach the team in providing superior customer support, managing vendors closely, in overseeing their project deliveries with accountability, and keeping up with industry standards as it relates to translations methodologies for clinical trials and medical devices and also copyright licensing.
  • Initiate and enforce continuous improvement initiatives geared to improve translation quality, process efficiency, harmonization across products, and reduce cost through tool and process enhancements that are scalable to various volume requirements.
  • Provide organizational support as it relates to management of instrument sub-licensing.
  • Develop strategic alliance, preferred vendor relationships, and operational efficiencies with select copyright holders.
  • Support new product releases by providing trained resources to implement operations readiness tasks for the department.
  • Responsible for producing accurate capacity analysis and for making necessary adjustments to ensure capacity meets pipeline requirements.
  • Primary contact to manage client and vendor escalations related to translations and instrument support.
  • Responsible for ensuring translations vendor fit with ERT in terms of cost, quality, subject matter expertise, and overall delivery.
  • Assists sales teams and review proposals as requested for translations, linguistic validation, and licensing procurement projects, work with the sales team to adjust and continuously improve the pricing model for translations projects.
  • Ensure all practices and procedures meet the regulatory compliance standards for Good Clinical Practices.

The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. ERT reserves the right to amend or change this job description to meet the needs of ERT. This job description and any attachments do not constitute or represent a contract.

 

Qualifications

Our ideal candidate will offer:

 

Skills:

  • Ability to negotiate with vendors, customers, and copyright holders
  • Excellent leadership and team skills
  • Strong Communication skills - verbal, written, and presentation skills required
  • Knowledge of 21 CFR Part 11 required
  • Strong proofreading and attention to detail is required
  • Excellent communication organization skills
  • Excellent analytical, problem solving, and Root Cause Analysis skills
  • Must be able to drive for results in a fast-paced environment

 Education:

  • BS/BA
  • Graduate-level experience in Copyright Law and/or IP strongly preferred.

 Experience:

  • 10-15 years management and/or combination of project management experience in technology or operations
  • Minimum of 5 years of experience and understanding of legal agreements, copyrights, and IP.
  • Familiarity with working in highly-regulated environments is preferred, and working in a Life Science related industry is a plus
  • Familiarity with software development industry and enterprise software is required
  • Experience with managing a team comprised of contractors and employees is required
  • Proven track record for adhering to timelines and being a productive cross-functional team member is required
  • Working experience interfacing with customers and vendors required
  • Minimum of 5 years of experience in negotiating contracts with 3rd party suppliers.

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

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