Manager, Scientific Affairs

Scientific Communication:

• Develop project management tools for scientific communication plans.
• Manage the development and submission of publications and presentations.
• Own relationships with investigators / authors of publications.

Pre-clinical and Clinical Research:

• Support trial design, protocol development and statistical analysis plans.
• Organize and/or lead meetings with clinical operations, clinical development engineering and R&D.
• Assist with and eventually lead strategic evaluation of pre-clinical investigator-initiated studies.

Regulatory and Reimbursement Initiatives:

• Oversee medical writing and literature reviews for all FDA submissions and Clinical Evaluation Reports (CERs).
• Manage healthcare claims analysis including benchmark research and vendor identification.
• Organize meetings or liaise with the market access team to ensure evidence generation and publication plans meet foreseeable needs.