The Opportunity

Reporting to the Executive Director, Strategic Projects, you will identify, oversee and support the implementation of required changes and innovations to enable to the transformation project in Medical Affairs. This includes reviewing all existing governance, representation to business-critical committees, standard operating procedures and workflows, and compliance within Medical Affairs. Based on knowledge of worldwide legal and regulatory requirements and internal standards, you will oversee the revision of existing documents and the creation of new ones. Additionally, you will oversee a needs assessment to evaluate opportunities to improve technology support and identify areas for technology augmentation to improve efficiencies across Medical Affairs, and subsequently to select and implement appropriate platforms.

• Provide subject matter expertise and oversight for all Medical Affairs-related governance documents including policies, charters, SOP, guideline, work instructions, and workflows
  
• Oversee and direct development of key processes and SOPs (e.g. Fair Market Value, Advisory Board planning and execution, publication practices) to ensure compliant standardization of processes throughout the Medical Affairs Global Organization
  
• Accountable to ensure monitoring and adherence to standards, documents and established workflows
  
• Oversee and direct the organization and execution of training on governance documents.
  
• Oversee and direct a comprehensive audit of current platforms in use by Medical Affairs across the enterprise and identify redundancies and opportunities to improve and standardize ways of working
  
• Identify areas for potential digital augmentation and oversight of vendor selection and implementation work
  
• Responsible for inspection and audit preparedness; first point of contact for all related Medical Affairs activities
  
• Represent Medical Affairs leadership on governance committees and enterprise projects related to further transformation initiatives including digital
  

• Degree in nursing, pharmacy or advanced degree in science/medicine (MD, PhD, PharmD) preferred
  
• Minimum of 7 years' industry experience (pharmaceutical, biotech or related field)
  
• Experience working in a global matrixed team organization
  
• Strong capabilities in project management, evidence generation, scientific engagement
  
• Working knowledge across multiple therapeutic areas and products