Key Responsibilities

• Initiate medical affairs activities including data generation and dissemination strategy; develop Global Medical Affairs strategy; deliver Medical Functional Plan and Brand Plan; ensure Area and Affiliate execution.
• Design, analyze, interpret, and report scientific content of protocols, Investigator Brochures, Clinical Study Reports, and Regulatory Submissions and responses.
• Oversight of Medical Affairs-led clinical studies; monitor study integrity; interpret and communicate accumulating safety and efficacy data; provide in-house clinical expertise; coordinate scientific activities with internal stakeholders and leadership.
• Participate in design and execution of clinical trial safety; resolve safety issues; perform safety monitoring; review and assess all Adverse Events (AEs) and Serious Adverse Events (SAEs).
• Serve as clinical interface; solicit leader input; partner with Medical Affairs, Commercial, and othe...