Sr. Quality Training Specialist (Temporary) - United States
- 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.
- 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
- 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