Medical Affairs Project Manager

Duration: 12 Months+

The Medical Affairs Planning & Operations Team is looking for the right candidate to dive right in and get down to business. You have initiative and are able to identify and problem solve, tech-savvy, perform well under pressure and have a results-oriented mindset. The position is in a team-oriented environment.

This position is in a pharmaceutical company and part of the Medical Affairs Planning & Operations organization. This role would support the day-to-day operations of the US & Global Medical Affairs team as follows:

Responsibilities:

• Oversee all day-to-day US Investigator Initiated Studies (IIS) activities to manage progress and ensure that each study is achieving specific milestones; support US IIS contracting and budget negotiations, identify and assess any issues and effectively resolve them in an efficient time and manner; create and edit reports regarding US IIS program status.
• Develop and maintain US & Global Medical Affairs financial forecasting and tracking processes
• Ensure IIS operational excellence across Clients’ Oncology US & Global Medical Affairs and external Alliance Partners; includes maintaining global IIS status and publication trackers
• Manage US & Global IIS protocol and manuscript review processes; work closely with the lead Medical Director of the studies, as well as other cross functional leads, including regional Medical Affairs, safety, clinical development, translational sciences, biostatistics, intellectual property, regulatory, etc.
• Oversee all aspects of the online IIS submission portal including operations, testing, training, and implementation of system upgrades, globally; primary point of contact for Client’s US & Global Medical Affairs and the portal IT support team
• Provide logistics management of IIS clinical drug supply for US Medical Affairs studies and preclinical API, globally
• Assist Business Operations in the day-to-day financial management for both US & Global Medical Affairs, including creating, managing, reconciling, and reporting forecasts and spend, including IIS
• Fiscal management to include working with US and a variety of country and regional offices (EMEA and Japan/Asia) to gather information and coordinate populating appropriate budget worksheets to completion
• Support other financials and related deliverables, assisting in updating and consolidating monthly reports

Requirements:

• Project management experience preferred
• Meeting organization and assistance; setting up and attending internal local and global meetings, setting agenda and taking minutes, and engage with all functions to consolidate materials for project meetings and deliverables, as needed
• Excellent organizational skills and ability to manage multiple projects and prioritize work
• Strong attention to detail
• Self-starter with excellent written and verbal communication skills
• Strong proficiency in MS Office tools, specifically Excel
• Proactive approach collaborating across the organization and to external partners with diplomacy and a firm understanding of other’s roles and perspectives, demonstrating a commitment to continuous improvement

Educational Qualification:

• BS or BA degree preferred
• 2 - 4 years Pharma Industry experience, including a basic understanding of Medical Affairs, clinical trial design and operations, and publications preferred

Shift: Day