ERT Product Lead in Boston, Massachusetts

Overview:

ERT is the leading cloud platform solutions provider that captures quality efficacy and safety endpoints, harmonizes data from any clinical source system, and delivers real-time insights for optimum trial performance – innovating better health for over 40 years and tomorrow. ERT’s combination of technology, services, and consulting increases the accuracy and reliability of patient data and improves the efficiency of the clinical development process throughout the product lifecycle. ERT provides sponsors and CROs with the most widely deployed solutions in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, and Clinical Outcome Assessments (COAs including patient, clinician, and observer reported outcomes). ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., U.K., Japan, and Germany.

We are seeking a Product Lead expert that directs and manages all activities related to the delivering new Products (Note: Service is a Product) including scope, design, architectural vision, feature definition, usability, as well as product launch, and defect management during development in support of ERT business requirements and in compliance with ERT SOPs.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  1. Work closely with Product Managers regarding product requirements and project details, and ensure that functionality delivered matches market requirements.

    1. Maintain and monitor project timelines and ensure accuracy in monthly reporting of project status. Includes definition of project timelines, securing of internal & external resources, process tracking, risk management (prioritization, critical paths and costs) and communication of project status.

    2. Manages release process for a Product. Includes coordinating with across the organization to develop and launch a Product on-time and on-budget.

    3. Communicates all potential risks (regulatory or other), operational deviations including summary root cause and CAPA metrics to Product Management personnel as necessary.

OTHER DUTIES AND RESPONSIBILITIES:

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. This job description and any attachments do not constitute or represent a contract.

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 AND SKILLS NEEDED:

  1. Bachelor’s degree (business or science-related field preferred)

  2. At least three years of experience in managing technology projects or Products

  3. Effective communication skills; written and oral in English and working with and leading cross functional teams

  4. Demonstrated project planning skills and track record of defining, developing, and launching successful Products

  5. For those positions managing (medical) devices, these additional qualifications apply:

  • Experience with (medical) devices and related technologies

  • Experience creating medical data management, data transfer and data storage systems including relevant standards

  • Experience creating medical devices including documentation (technical file) for CE marketing, FDA 510(k) and other country approvals

  • Experience with GMP, GCP, 21 CFR Part 11, MDD; preferably trained as Medical Device Consultant

For positions managing respiratory / Cardiac Safety Products additional qualifications apply:

  • Strong background in the area of Spirometry and/or ECG or similar experience in signal processing/data acquisitions of vital signs (expert knowledge in the area of respiratory diagnostics and or cardiologic diagnostic equipment preferred)

  • Has worked under a Quality Management System covering medical device design, development and manufacturing. The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.

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.

Hours: Full-time/Regular

External Company Name: eResearch Technology

External Company URL: www.ert.com