Melissa Landers
- Role
- Senior Principal at Two Labs
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Melissa Landers
Experienced leader with more than 20 years of management consulting experience, 17 in the…
Experience
Senior Principal
Oct 2021 — Present
Lead engagements in the following areas of expertise: REMS Strategy, advising Regulatory and Commercial leadership on the need for a REMS, program design, FDA negotiations, and REMS administrator system selection Shared Safety Program Management, implementing operations and oversight infrastructure to support direct competitors working together on programs required by regulatory agencies to market product Medical Affairs Strategy, helping leadership assess and refine processes for operational excellence, compliance with regulations, and implementation of supporting technologies Launch Management, guiding Commercial and Regulatory teams to work with internal and external stakeholders to plan, coordinate, and execute new product launches Change Management, providing strategic guidance on large-scale system and/or organizational changes, as well as project management
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