Associate Training and Document Management in Basking Ridge, New Jersey at DSI

Date Posted: 11/27/2019

Job Snapshot

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 Training and Documentation Associate is for supporting the implementation and oversight of Inspection readiness, Documentation and Training programs as required. With direction from leadership and with stakeholder collaboration establish metrics and Key Performance Indicators (KPIs) to ensure the regulatory compliance. The Associate with be responsible for management of GxP Documents and records per regulatory records management principles.
  • Support Training and document management efforts related to systems, processes, or tools to enhance training performance and maximize document management capabilities to better serve the organization.
  • Support the review all training records for completeness and formatting accuracy including supporting related appropriate training system management for accuracy and completeness.
  • Support the development and implementation of role-based Training curriculums and serve as specific support for organizational document and training compliance needs; including as a technical resource or subject matter expert for the acquisition and use of learning technology
  • In consultation with leadership and stakeholders, support training associated with specific Quality and Productivity initiatives. Liaise with other functions to coordinate Inspection readiness and Training activities. Partners across organization to streamline and continuously improve Inspection readiness and Training programs to ensure compliance.
  • Support audits and inspections with the goal of compliance to regulations and global harmonization. Support Training and documentation/record retention efforts and outcomes related to inspection readiness and post inspection commitments.
  • Support the company initiatives including deviations and corrective and preventative actions for compliance, including support of audits and inspection.
Related/Relevant Skills
  • Demonstrated ability to effectively communicate and implement outcomes. Proven ability to manage projects/teams of significant scope and complexity with enthusiasm, prioritizing workload with attention to detail while meeting all deliverables and timelines
  • Resourcefully manage conflict. Works with a sense of urgency and ability to recognize critical deliverables.
  • Client focused and attention to detail. Demonstrate organizational and emotional intelligence and awareness. Relevant leadership competencies with ability to work collaboratively with cross functional stakeholders to drive process improvements
  • Serve as a positive QA ambassador. Demonstrated strong aptitude for supporting GxP Documentation and Training programs. Ability to implement compliance solutions
  • Ability to successfully plan, adjust, manage training and documentation requirements for the advancement of organizational goals and objectives.
  • Works independently, takes initiative and has a flexible approach to work assignments and other assigned tasks. Good understanding of clinical research and trial delivery principles and processes for clinical trials a plus
  • Demonstrated ability to support and implement global training and documentation management
Responsibilities:
Program oversight, Quality focus (local/global) and Continuous Improvement
  • Support the Training, Document management and Inspection readiness programs. Work with global and local teams/leaders to implement the appropriate related solutions and procedures. Escalate related issues and/or systemic problems with appropriate recommendations/solutions to Senior Management for immediate and long-term resolution in accordance with Global procedures/practices and training best practices
  • Generate and monitor Key Quality Indicators (KQIs) and metrics to support overall training compliance. Update Procedures and Training materials as need to support organizational Quality related activities.
Cross-functional/Stakeholder Support
  • Provides the appropriate support to key stakeholders (ie. Clinical trial support) to support compliance regarding Training, Documentation and Inspection Readiness programs. Liaise and act as point of escalation for communications across R&D, to support compliance, as applicable.
  • Support research and development activities for compliance and ensure that supported programs are conducted in accordance with Good Clinical Practice (GCP), protocol, EU Directives, MHRA Statutory Instruments, International Conference on Harmonization (ICH) and Global Policies and Procedures, as applicable
  • Serves as a point of contact for QA SOPs/Procedures, documentation management and Inspection readiness programs
  • As main point of contact for document management ensure regulatory and legal requirements are met. Manage, implement and enforce retention schedules as applicable.
Audits, Inspections and Compliance
  • Liaise with internal teams and functional departments when appropriate to ensure global coverage to inspection readiness activities. Serve as the key contact for Regulatory Inspections, as necessary including document management in accordance with the local and lobal requirements
  • Advanced knowledge in supporting audit/inspection programs, reporting of audits observations and the translation of related findings into corrective actions plans that mitigate risks to the organization and to patient safety and data integrity
  • Support Document and Record retrieval including SOPs and procedures to support internal audits and inspections as applicable
  • Act as a key resource to support Inspection readiness activities, including taking key roles in the back room to support the broad organization to ensure inspection execution success.
Qualifications
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • Associate or Bachelor’s Degree preferred
  • At least 3 years (w/Assoc Degree) of experience in Quality Compliance Training/Document management Programs and or Inspection Readiness in the pharmaceutical/medical device industry with involvement in regulated clinical trials and / or technical QA activities (i.e., Clinical Trials/Operations etc).
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. 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.