Job Abstract

Job ID

2024-1850

# of Openings

1

Category

Quality Assurance

Entrepreneurial Spirit, Rooted in Tradition. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan’s most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), amyotrophic lateral sclerosis (ALS) and Parkinson's (PD).

MTPA is rapidly expanding its operations across all functional areas. MTPA’s commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets. In the United States, MTPA launched rare diseases treatments including RADICAVA® (edaravone) injectables in 2017, EXSERVAN™ (riluzole) oral film in 2021, and RADICAVA® (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions. MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness.

The primary role of the Director, Learning Management & Training will be to lead and manage the development, implementation and maintenance of GxP and non-GxP training programs at Mitsubishi Tanabe Pharma America. This position will ensure systems and processes are robust and complaint in order to meet the regulatory and end user needs.

• Defines and establishes the training program strategy and best practices for Mitsubishi Tanabe Pharma America GxP and non-Gxp functions.
• Streamlines processes and procedures to ensure enhanced user experience, including as appropriate, development and oversight of effective role-based training curricula and training material.
• Functions as the global LMS administrator by maintaining permission and security roles within the system for all regions, manages global licensing, reviews contracts with the vendor and system releases.
• Manages and maintains the LMS tool including defining direction and writing SOPs and Policies related to system administration, compliance and organizational development.
• Provides oversight, onboarding and training of regional LMS administrators and provides system support and initiation of new training projects.
• Manages the annual LMS governance meetings for all regional administrators, presents and aligns on changes impacting global training program.
• Establishes and standardizes the framework for monitoring the system and training effectiveness through key performance indicators.
• Leads the development and administration of the annual GxP training and product quality complaint training.
• Presents during Quality Management Reviews and takes action to address any improvement activities.
• Ensures the training program is in a continuous state of inspection readiness, presents during regulatory inspections and alliance partner audits.
• Ensures compliance with all LMS procedures to maintain the validation status of the system and ensures system is kept current with respect to active users.
• Works with functional departments to identify functional training coordinators; ensures appropriate training (trainer certification, coaching and feedback, system access and subject matter expertise).
• Strategizes with stakeholders to determine and prioritize training needs and directs the development and delivery of training material.
• Interfaces with document control function and business process owners to ensure assessment and update of training curricula is completed as a result of updates to procedures.
• Promotes teamwork, cross collaboration, coordination, and communication across disciplines and departments.
• Manages/develops direct reports and fosters professional development and growth.

• BS/BA in either a scientific or related discipline. MS or specific training / certification, is a plus
• Minimum 12 years of experience with at least 5 to 7 years designing and implementing programs and initiatives from needs assessment through delivery. Minimum of 5 years management experience. Minimum of 5 years' experience of eLMS and eLearning tools.
• Biotech/pharmaceutical/GxP industry experience and extensive knowledge of GxP training program requirements including expertise with electronic management systems tools such as ComplianceWire.
• Strong change management skills and demonstrated ability to simplify and improve business processes.
• Excellent leadership, strategic thinking skills with the ability to motivate and manage a team with matrix reporting relationships.
• Working knowledge of 21 CFR 210-211, 21 CFR 11, 21 CFR 820
• Driven, results-oriented self-starter and excellent team player.
• Strong collaboration and influencing skills.
• Well-honed project management skills. Proven ability to simultaneously manage activities associated with multiple projects and programs under tight timelines.
• Adaptable to a fast paced, complex and ever-changing business environment.
• Demonstrated creative problem-solving skills under resource constraints and time pressure.
• Excellent written and verbal communication/presentation, documentation and technical writing skills.
• May require some travel up to 25% both domestically and internationally.

Our Value Proposition:

Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits.

MTP provides a competitive benefits package inclusive of Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance and additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection. In addition, we provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date.

The salary range for this position is $155,000 - $264,000. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary may be subject to a geographic adjustment (according to a specific city and state and depending on the role), if an authorization is granted to work outside of the location listed in this posting.

This position is eligible to participate in our annual Short-Term Incentive (STI) program. Specific information about the plan including eligibility rules and target, will be furnished upon hire.

This position is eligible to participate in our Long-Term Incentive (LTI) program. Specific information about the plan including eligibility rules and target, will be furnished upon hire.