This role leads a team responsible for scientific and tactical regulatory strategy, submissions, approvals, and compliance throughout drug development. Oversight of the Regulatory/Medical Writing Group is also required to ensure consistent, efficient, and timely document development.

Help build and manage the relationships with relevant CROs, facilitate thorough understanding of clinical studies, assist in patient recruitment, and help assure trials are executed on time and within budget.

Demonstrate market knowledge and leadership with both internal stakeholders (including cross functional teams such as Market Access, Field Reimbursement, Operations, Marketing, Trade and Sales teams) and external stakeholders (Centers of Excellence (COE) decision makers, Key Opinion Leaders (KOLs), etc.).

Thoroughly understand account-level decisions that impact product access within territory and develop plans on to best address to ensure patient access to care (such as product placement on formulary and inclusion into Electronic Medical Records (EMRs)).

Thoroughly understand account-level decisions that impact product access within territory and develop plans on to best address to ensure patient access to care (such as product placement on formulary and inclusion into Electronic Medical Records (EMRs)).