Training Specialist II

Alkermes Waltham , MA 02154

Posted 3 months ago

Company Overview

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com .

Position Summary:

Training Specialist II is responsible for the architecture of the LMS for the Waltham site and the Executive Node, including but not limited to compliance and other required departmental training and reporting. This position will focus on the optimization of the LMS as the system of record as outlined below, and will support both technical and administrative aspects of the system.

Responsibilities:

  • Define and uphold standards regarding curriculum content, format, and approval processes, including metrics

  • Provide timely and accurate support to regulatory agency inspections and audits

  • Optimize, vet, and maintain LMS content, according to defined standards.

  • Work with subject matter experts to determine the optimal training type for content and intent (i.e., instructor led vs. read-and-sign vs. CBT)

  • Upload new training items, which includes those created by L&D and Subject Matter Expert (SME) curriculum designers Create new accounts in LMS for and temporary staff

  • Assign curricula to new hires and existing employees

  • Partner with SMEs to evaluate curricula for appropriate assignment and timing

  • Create, edit and maintain training items, curricula, users, and user groups in the LMS

  • Create, assign and maintain Qualified Trainer Forms in collaboration with L&D

  • Monitor and Manage LMS curricula in partnership with managers and SMEs

  • Manage upgrades and technical releases for the LMS in partnership with vendor and other site LMS Administrators

  • Troubleshoot LMS in partnership with IT Administrator

  • Test internal and vendor configuration changes

  • Understand how LMS interacts with other key systems

  • Update system related procedures, work instructions and training manuals as required

  • Provide end-user support for LMS users and/or refer to IT Support for technical issues

  • Facilitate annual (comprehensive) review curricula

  • Lead key departmental and global projects ensuring effective management and delivery

  • Introduce improvement ideas by staying on top of the latest industry trends and practicing continuous improvement standards

Skills / Experience:

  • BA/BS in Computer Science, Business Administration, Learning and Development or related field

  • Minimum 5 years of experience in LMS Administration is required, experience with ComplianceWire required

  • Experience in a GxP or other regulated industry required

  • Understanding of quality systems

  • Experience in curriculum design preferred

  • Experience in software/application testing preferred

  • Highly collaborative

  • Results-driven, quick study to understand all areas of the business

  • Strong organization skills and attention to detail

  • Strong written and oral communication skills

  • Ability to work in a fast-paced environment and shift priorities as necessary

  • Ability to influence change across multiple groups and levels

  • Prior success in leading harmonization efforts across teams and sites

  • Self-disciplined, self-motivated and self-initiated

  • Ability to manage relationship with vendors to meet business expectations

  • Partner with owners of shared systems to understand relationship between systems

  • Identifies opportunities to optimize use of system to meet business requirements

  • Willing to travel (20%)

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.

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Training Specialist II

Alkermes