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.
The Role
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
Your skills and experience
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
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
