Goli S.
Senior R&D Project Manager at Biogen
- Role
- Senior R & d Project Manager(Pmo)-neuromuscular & Device at Biogen
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Goli S.
RELATED COURSEWORK: • Project Management Methodology, Project Planning and…
Experience
Senior R & d Project Manager(Pmo)-neuromuscular & Device
Oct 2022 — Present · Raleigh, NC, US
Manage R&D programs throughout the lifecycle, including Biopharmaceutical and Medical Device programs (Class and 510(k)), with experience in IDE submissions and PMA processes; partner with cross-functional teams to ensure strategic alignment, timely execution, and delivery of key milestones under tight deadlines. • Track programs through all the Clinical Phases, IND filing from a regulatory perspective, coordinating submission readiness, cross-functional deliverables, and alignment with evolving regulatory strategies.• Served as Development Project Manager for Integration Plan, a high-sensitivity Business Development initiative, collaborating with Business Development and Strategy teams to align the functions, coordinate cross-company deliverables, and drive seamless asset integration.• Led and streamlined R&D Governance Process, delivering Governance Training for the PMO team and creating the first Governance Metrics and Dashboard, significantly improving decision-making efficiency, transparency, and accountability.• Designed and implemented governance operating processes with my Lean experience that enabled effective collaboration among program teams, Development Asset Leaders, and Governance Committees, strengthening alignment and operational consistency.• Introduced Lean and Kaizen principles to PMO processes, driving continuous improvement, simplification, and stronger engagement across teams.• Supported the Quality Analytics Team by contributing to the Governance Chatbot process (AI).• Advanced project management tool adoption by:• Creating and delivering Planisware training to enhance PMO proficiency• Setting up a device timeline template in Planisware to standardize planning• Introducing Smartsheet as an integrated timeline tool for programs with external partners• Presenting a Critical Path slide to the PMO team, improving visibility of dependencies and risks
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.