Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
This opportunity can either be hybrid (part-time on campus) from our Cambridge office or fully remote.
About This Role:
The Manager, BPE, is responsible for process document management (PDM), including the processes and systems used to manage process. Process management includes ownership, documentation, monitoring, and improvement. This role is responsible for creation, quality control checking (QCing), and processing SOPs, JAs, Forms, Templates, and other types of process documents, consulting with document owners to guide them through the process, and ensuring all steps are being followed. This role oversees systems and processes that maintain the R&D business process framework and documentation standards such as the Electronic Document Management System (EDMS) and the BPE SharePoint sites. This role leads and participates in special projects as needed and may coordinate the work of contractor/FSP staff as required.
Who You Are:
You love the idea of being able to help every function across R&D to manage and improve the processes that allow us to get lifesaving medicines to patients in this highly regulated industry. You thrive in a fast paced environment, requiring you to juggle multiple varied tasks and learn new technologies.
What You’ll Do:
- Creation, quality control checking (QCing), and processing SOPs, JAs, Forms, Templates, and other types of process documents, consulting with document owners
- May own one or more departmental processes
- Support systems such as the Electronic Document Management System (EDMS) and BPE SharePoint sites
- Lead special projects as needed to support business process management
- May lead or support CI initiatives across R&D
- 5+ years relevant work experience, ideally in the biotech / pharmaceutical industry
- Working knowledge of Good Practice Standards (GxPs)
- Experience with technical writing for SOPs, job aids, forms and templates
- Knowledge of good documentation principles
- Sound project management and organizational skills
- Attention to detail and proven ability to lead and/or support multiple small projects at one time
- Good written and verbal communication skills
- Continuous Improvement (CI) expertise (Lean Six Sigma Yellow Belt preferred)
- Extensive knowledge of Electronic Document Management Systems (EDMS)
- Experience creating and maintaining SharePoint sites
All your information will be kept confidential according to EEO guidelines.