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Sr. Quality Training Specialist (Temporary) San Rafael United States,  

Biomarin (company)

Posted on : 24 June 2017

Project Description

  • Our company  is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. 
  • These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. 
  • Our company will continue to focus on advancing therapies that are the first or best of their kind. 
  • The Training Sr. Specialist is responsible for driving the design, development and delivery of training and education across the company Development Sciences in areas of GxP, compliance, and Controlled Documents. 
  • The Sr. Specialist is expected to act as a training subject matter expert for the Development Sciences organization, offering guidance to customers and project teams on training-related solutions and approaches as well as input on continuous improvement and design standards related to training materials.

Course Development 
  • Oversee, design, develop and implement learning programs, training courses and materials to educate/increase knowledgebase of Development Sciences employees in relation to clinical trial related activities
  • Work with stakeholders to develop overall training strategies, programs, and curricula for specific topics or functions
  • Assess and identify training needs in collaboration with subject matter experts, cross functional leads, and key business stakeholders
  • Develop or updated training materials based on functional area needs assessments or training requirements based on document requirements (e.g., SOP) 
    • Design curricula that fit the key goals of the learning program, including timeframe, expected outcomes, level of interaction and engagement, and specific audience needs
    • Work with stakeholders to finalize the training materials
  • Assist with the development of a variety of knowledge assessments, including quizzes, that suit the project or program needs
  • Participate in the procurement and management of 3rd party training contractors/vendors for complex projects

Training Execution
  • Develop and deliver training using multiple methodologies (e.g. instructor-led, e-learning, webinars)
  • Coordinate or oversee tasks as assigned, including, but not limited to, monitoring and submitting attendance to verify credit is given and any related communication.
  • Conduct and review course evaluations to verify that efficient, effective, value added training to learners is provided to DevSci personnel
  • Oversee training records management, including tracking attendance, recording learner histories, and developing training compliance metrics

Must have good working knowledge of:
  • Regulatory environment (guidance, guidelines, trends, changes, etc.)
  • Good Clinical/laboratory/pharmacovigilance Practices (GxPs)
  • Clinical Trials and Development (e.g. phases of trials, data management principles)
  • Quality management principles and quality management system
  • BA/BS in life sciences or technical area; experience in lieu of education may be considered
  • 4+ years of relevant pharmaceutical industry experience

Equal Opportunity:
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.


San Rafael California

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