Project Coordinator, Regulatory Affairs

Company: Adverum Biotechnologies, Inc.
Location: Redwood City
Posted on: June 6, 2021

Job Description:

Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum's core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.

Adverum Biotechnologies is looking for an experienced Project Coordinator, Regulatory Affairs to join our team in Redwood City office.

What you'll do:Drive Regulatory Affairs projects and process improvement activitiesActively engage and collaborate with the Regulatory Affairs team members and other key stakeholders to achieve the goals set out in the departmentEmploy solutions to enhance processes, technologies, and activitiesLead cross-organizational activities and ensure that team members are aware of and meet all expected deliverables and outcomesDevelop, manage, and drive timelines and milestones for projectsRaise new ideas and facilitate meetings to brainstorm and create solutions, as appropriateResponsible for coordinating and facilitating cross functional meetings for regulatory submissions Manage and facilitate initiative and project team meetings with traditional project management deliverables such as creating and managing project reports, presentations, materials, team agenda and team meeting minutes/outcomes and follow through on all deliverablesDevelop and maintain a project plan for all assigned projectsProactively identifies activities that need to be completed and actions them accordinglyEnsure plans are implemented in accordance with timelines and any issues, challenges or deviations are escalated for resolution in a timely manner and ensure alignment of team activitiesPrepare presentations for meetings, forums and leadership requestsProvide project management support for various GRA functions such as the Reg Tech Ops and Reg Strategy groupsSupport efforts to develop and maintain key performance indicatorsInterface with senior management on various projects and initiativesAbout you:Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc.Able to successfully interpret and apply regulatory intelligence to work outputKnowledge and experience of RIMSBachelor's degree or equivalent experience in life sciences, scientific, fieldPrior experience working in the pharmaceutical/biotech industry requiredExperience managing cross-functional project teams3-5 years project management experienceKnowledge of the drug development process and/or Regulatory AffairsPay strong attention to detail, think analytically Demonstrated contributions that have helped innovatively transform processes, technology, roles, organizational activities and collaborationsThe candidate should have exceptional oral, written communication skills, presentation skills and be knowledgeable with software applications that will be regularly used (in particular; Excel, MS Project, SharePoint, Microsoft Teams and PowerPoint)Preferred: Certification in project management (PMP) is desired but not requir

Keywords: Adverum Biotechnologies, Inc., Redwood City , Project Coordinator, Regulatory Affairs, Other , Redwood City, California