General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker to play a critical cross-functional role, driving Regulatory Body (Us/ex-US) Inspection Readiness timelines and Quality System activities forward. Serve as the “glue” of communication between quality, clinical, medical, regulatory, pharmacovigilance, data management/statistics, and program management. Assist in developing project plans, timelines, communication processes, and standards. Responsible for coordinating Quality System business objectives and ensuring that processes meet Sage standards and long-term business goals.
Roles and Responsibilities
- Collaborate with cross-functional teams to drive timelines and establish deadlines, to monitor and summarize progress of projects, and to ensure accountability within the team.
- Develop communication processes and standards of operating to drive progress.
- Facilitate or support Inspection Readiness Meetings: develop agendas and meeting minutes, assist in leading meetings, and proactively support issue and action resolution.
- Identify and monitor key project tasks and dependencies, and assist in the development of risk mitigation and management strategies.
- Build and maintain working relationships with internal and external team members involved in the projects.
- Support the team in developing and reporting project metrics and status updates.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Ability to analyze issues to develop realistic and measurable plans and to anticipate risk. Ability to build sustainable relationships with other team members and to create/promote an effective working environment for the team. Excellent communication and project management skills and a high level of organizational skill.
- B.S. or M.S. in a discipline relevant to the biological sciences and a minimum of 5 years of experience within the biotech/pharmaceutical industry in a role requiring an understanding of clinical drug development.
- Demonstrated knowledge of a variety of project management concepts, practices, and tools.
- Experience working with all levels of management and consulting with key business stakeholders. Ability to lead through influence and drive timelines forward. Plays well with others.
- Fluid use of MS Project, Excel, PowerPoint, and Outlook.
- Demonstrated experience working in a matrix environment.
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Possesses strong written and verbal communication skills.
- Experience with Regulatory Agency Inspection (BiMO/PAI/EMA/MHRA), a plus
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
- Excitement about the vision and mission of Sage.