Becton Dickinson (BD) recently completed the acquisition of the Edwards Critical Care business.  This position is part of the Critical Care division, and as such will become a part of the BD organization in the future.  Critical Care will operate as a separate business unit, called Advanced Patient Monitoring (APM) within BD's medical segment, aligning with BD's smart connected care approach.   BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. If you are invited to interview for this position, a recruiter will provide further details about this exciting transition. Learn more about BD at bd.com 

Provide expertise on Medical Affairs programs, make sure the local teams are staying up-to-date with the activities of this Global program- and to regionalize the assets.
 

You will make an impact by...

-Analyze and evaluate changes in laws and regulations relating to IIS and identify the impact on Edward and share recommendations internally

-Analyze and evaluate emerging medical treatments and clinical outcomes for products related to Edwards, and recommend where Edwards should change current processes.

-Review and approve medical content in BU promotional materials, including educating marketing team on best approach to write medical related content

-Manage the review and assessment of new IIS (Investigator Initiated Study) proposals while insuring compliance with Medical Affairs processes. Perform creative research and analysis to prepare for presentations and collect missing information for ensuring an informed review process of proposals.

Implement and manage the database for all IIS’s, track milestones accomplishments and insure associated payments.

-Provide assessment to sites and investigators, determine challenges, and define mitigation plans. -Provide regular updates to management and business unit partners on ongoing studies

-Responsible for annual budget and monthly forecasting reporting for IIS studies. Collaborate with cross functional teams to determine allocation of funds.

What you'll need (Required):
-Bachelor's Degree in in related field , 8 years years experience of previous related experience Required and
-Experience in Clinical Affairs or Regulatory Affairs in Medical Device or Healthcare industry Required
-Master's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry) Preferred

What else we look for (Preferred):
• Proven successful project management skills
• Proven expertise in both Microsoft Office Suite, including advanced Excel.
• Excellent documentation and Scientific Communication & Exchange skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Excellent English skill
• Extensive knowledge of medical affairs within the organization while contributing to the development of new concepts, techniques, and standards
• Extensive knowledge and understanding of Edwards policies, procedures and guidelines relevant to Medical Affairs
• Extensive knowledge of all medical affairs strategies
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to manage competing priorities in a fast paced environment
• Represents leadership on sections of projects within a specific area interfacing with project managers and medical affairs team
• Provides leadership to outsourcing partners on a task level
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control