Mgr CSPV Training in Bernards, NJ at DSI

Date Posted: 11/15/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Bernards, NJ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/15/2018
  • Job ID:
    9385BR

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary

The position is has the responsibility for identifying training needs for CSPV staff and developing and overseeing training to ensure awareness of and compliance with organizational objectives and global laws and regulatory requirements. With support from the Associate Director of PV Quality, Compliance, & Training, the Training Manager will take a lead role in the design, development, and coordination of training programs based on corporate, organizational and individual needs, collaborating with CSPV management and cross-functionally to ensure training needs are met. He/she will be responsible for training issue management including identifying solutions and addressing inquiries. The Training Manager will be responsible for the implementation and maintenance of the Global Training Matrix for CSPV and leading related process improvements as necessary. The Training Manager will support CSPV Safety training activities including the Adverse Event Reporting Policy Training being appropriately managed in accordance with corporate and regulatory requirements, which includes facilitation of updates to the training content, evaluation of training adequacy, and appropriate distribution of the training. He/she will work closely with DSI’s Learning Management System (LMS) Administrator to access necessary training reports and to ensure proper training documentation. He/she will also work closely with CSPV Quality & Compliance to monitor compliance with staff training requirements, and address and coordinate escalation of non-compliance. The Training Manager will mentor and provide support to CSPV instructors, subject matter experts and supervisors in techniques and skills for conducting effective training for staff as needed. May participate in creation, review, and revisions to controlled documents and procedures. Liaises with CSPV management and cross-functional teams as necessary throughout the corporation to optimize CSPV training quality.

Responsibilities
  • Training Program: Takes a lead role in the design and development of CSPV training programs based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable. Collaborates with relevant functions and management for new staff on-boarding and general safety reporting training at DSI.
  • Training Plan and Delivery: Takes a lead role in the design and development of CSPV training programs based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable. Mentors instructors, subject matter experts and supervisors in techniques and skills for conducting effective training for staff as needed. Oversees the quality and consistency of training conducted within CSPV. Collaborates with relevant functions and management for new staff on-boarding and general safety reporting training at DSI. Resolves and responds to training issues and questions.
  • Training Records and Maintenance: Works with Quality and Compliance to identify training compliance, and coordinates escalation of non-compliance. Works with DSI’s LMS Administrator to generate/access necessary training reports and to ensure proper training documentation. Responsible for the implementation and maintenance of the Global Training Matrix for CSPV and leading related process improvements as necessary. Supports the annual roll-out of the Adverse Event Reporting Policy Training assigned to all company staff globally, which includes project management, facilitation of updates to the training content, evaluation of training adequacy, and appropriate distribution of training (with technical support from the LMS Administrator for LMS assignments). Ensures training processes and relevant materials are up-to-date. May participate in creation, review, and revisions to controlled documents and procedures.

Qualifications

Education and Experience
  • Bachelors of Science degree required
  • Minimum of 5 years drug safety experience
  • MS, RN, or PharmD preferred, or 7 years total pharmaceutical industry experience in one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development
  • 3-4 years of direct experience in Training or PV Training, global setting preferred

Competencies
  • Ensures high quality work is completed throughout the function and that internal and external expectations and timelines are met.
  • Develops functional strategic plans, provides guidance on priorities within the function and leads implementation.
  • Expertly identifies issues independently, thoroughly understands cause of issues, recognizes functional impact, develops and implements solutions.
  • Expert scientific knowledge is used to provide leadership and to serve as subject matter expert throughout the function.
  • Routinely interfaces, collaborates, and negotiates with project and functional leaders to drive results and resolve complex issues.
  • Assists in driving timely management decisions, appropriately shifts functional timelines, resources and priorities to address regional needs.

Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.