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Description

Reporting to the Head of R&D Business Operations this role will work with the Head of R&D Business Operations to execute the R&D strategy related to driving R&D operational excellence. 

The incumbent will work with the Head of R&D Business Operations to manage the overall planning, execution, and delivery of key R&D initiatives that support the overall R&D goals. This will include being the R&D Training Lead and R&D Archivist (paper). You will lead cross-functional R&D continuous improvement to enhance R&D effectiveness. You will partner with other internal departments in cross-department projects and represent R&D with external vendors.

Essential Duties and Responsibilities

• R&D Training Lead: Owner of the R&D Training platform and associated processes including (but not limited to):
  • Develop and manage a consistent and comprehensive R&D interview and onboarding process
  • Develop an R&D training platform to include functional- and project-related training for both internal and external team members
  • Own the R&D Training SOP and associated forms and training matrix
  • Be the R&D Inspection and Audit Training SME to include the retrieval of training records for employees
  • Develop & implement R&D GxP refresher regulatory compliance training
  • Manage and report on training compliance metrics
  • Manage R&D staff training inquiries
  • Facilitate R&D lunch and learn series
• R&D Archivist (paper): Manage the R&D paper archiving process and vendors. Assist in sending/retrieving paper from archives in a timely manner:
  • Maintain a collaborative relationship with off-site vendor archive contacts
  • R&D Liaison manage scheduling of pick-up and deliveries to the facility working with R&D functional SMEs responsible study for document management
  • Manage scheduling of pick-up and deliveries to the facility, monitor associated costs make recommendations to Management regarding the vendor relationship
• Graduate / Internship Program: Assist the Head of R&D Business Operations to manage the R&D graduate/internship program:
  • Support Head of Business Operations by fostering & maintaining collaboration with academic institutions
  •  Coordinating with R&D functions to assign projects, and ensuring the program aligns with the R&D department objectives
  • Oversee Graduate/Intern onboarding and training. This includes providing guidance, assigning mentors, and facilitating onboarding or training sessions
  • Serve as a liaison between the graduate/intern program participants and the R&D functional teams. Facilitating communication, coordinating project assignments, and ensuring a productive working environment for both parties
  • Oversee Graduate/Intern off-boarding program metrics including, gathering feedback from program participants, tracking functional team feedback, and incorporating innovative approaches to make the program more impactful
• Vendor & Contract Management: Work with the Head of R&D Business Operations to enhance vendor selection, management and oversight including the establishment of preferred vendors.

Job Related Qualifications/Skills

Professional Experience

• Required:
  • Extensive knowledge of ICH GCP and ISO
  • Device/Pharmaceutical background
• Preferred:
  • Stakeholder facilitation and management

Knowledge, Skills, and Abilities

• Required:
  • Excellent interpersonal skills
  • First-class organizational skills
  • Excellent MS Office skills  
  • Proven success in training, archiving and process improvement                                                                                                                     
  • Proactive approach to work; demonstrates initiative and reliability
  • High standard of written and spoken English
• Preferred:
  • Excellent negotiation skills

Education

• Required: 
  • Strong process improvement background e.g., Lean Six Sigma Certification
• Preferred:
  • Life sciences degree-level qualification

Behaviours

Motivation

Education

Experience

Licences & certifications