Manager, Training

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) ensures full integration of development and commercialization activities, from initiation of the clinical program for a compound through product positioning and global life cycle management, which will lead to globally consistent branding of our products.

Otsuka is seeking a Manager, Training for our Rockville, MD or Princeton, NJ offices to serve on the OPDC Training Team in a training and compliance capacity. The individual will partner with the Director of Training in the implementation, editing, and follow-up duties for training focused on process efficiency and regulatory compliance requirements and manage internal as well as external training projects working with internal Subject Matter Experts (SMEs) and external consultants. The incumbent will also interact with all levels of the OPDC organization. 

The specific duties of the Manager, Training include the following:Contributes to the assessment of overall training needs for OPDC with input from senior management and staff and reports on these assessments with recommendations for training. Independently assess individual training requests, research, recommend and/or develop solutions to a variety of training issues of moderate/difficult scope and complexity. Thorough knowledge of the current curriculum and contributes to the development and maintenance of a training curriculum consisting of courses, seminars, e-learning modules as requested, and/or suggested improvements in current course curriculum. Execute and implement all training needs identified. Executes assigned responsibilities on corporate initiatives and functions as management support for implementation and compliance of the same. Serves as internal expert on OPDC processes and business practices. Serves as a resource for compliance and drug development process informationConsults with FA heads and Project Team Leaders on appropriate training plans and approachesConducts any session offered by OPDC Training. Contributes to the implementation and follow-up of internal training sessions and ensures all preparations are made for implementation of internal courses.Manages external vendors and projects for outsourced training.Set-up relationship with vendors, manage contracts, budgets and deliverablesActs as a liaison for external experts in setting up on-site training sessions.Provides suggestions for improved testing methodology/questions and/or create questions that accurately reflect procedure or assessment of training conducted. Ensures accurate reporting and quality control of the Learning Management System.

The successful candidate must meet the following minimum requirements:Bachelor's degree with 4 years of experience in the pharmaceutical industry or previous training experience.2 years of Project management/outsourcing management experience. Requires a solid understanding of clinical operations, regulatory affairs, commercialization activities, and requirements for launching a new drug.Excellent knowledge of GCP/regulatory compliance activities necessary for day-to-day operations of clinical trial management and study site management, and the clinical drug development process.Keeps up with new developments and trends in the industry.Demonstrated skills in the design and implementation of training, including development of materials and delivery of training programs.Excellent oral and written communication skills to be well understood by all levels of employees.Excellent presentation and facilitation skills.Ability to accomplish objectives through influence in a matrixed organization.Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).

For immediate consideration, qualified candidates should apply online at www.otsuka-us.com   Click on OAPI, Careers, then Employment Opportunities.  Enter 08-101 for keyword search. 

 

Otsuka is an Equal Opportunity Employer.