Manager – Business Support and Contract Management

Manager – Business Support and Contract Management

Requirements

• Bachelor’s Degree in one of the life sciences or clinical research and/or a licensed healthcare professional required, or equivalent experience
• Minimum of 5 years of relevant industry experience which includes at least 3 years of drug safety experience
• In-depth knowledge of medical terminology and of GCP, ICH guidelines, global drug safety and drug development process, and current US and international pharmacovigilance regulations
• Project leadership/management skills
• Ability to multi-task and shift priorities quickly while working under tight deadlines
• Effective time management and organization skills
• Good interpersonal, written, and verbal communication skills
• Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required
• Skilled in developing collaborative internal and external relationships
• Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
• Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing department and company
• Must have a high degree of professionalism, and ability to work with limited direction
• Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks

Responsibilities

• Manage the DSPV Contracts Management process and invoices with our PV Safety Vendor, establish routine touch points with the necessary vendor stakeholders and maintain current knowledge of the procurement process to efficiently receive of all DSPV invoices within the Insmed Procurement/Jaggaer portals and effectively manage any concerns.
• Manage the DSPV budget, including forecasting, tracking expenses, and ensuring alignment with financial goals.
• Manage and track Exhibits with the PV Safety Vendor to ensure their set up and renewals within the timelines.
• Liaise cross-functionally and regionally with Biostatistics/Data Management, Clinical Development, Clinical Operations, Clinical Sciences, Commercial, Legal, Medical Affairs, Product Quality, Regulatory Affairs and others as needed to ensure processes are in place for activities performed by those functions that impact full range of PV Business Support and Contract Management and cross-functional activities.
• Support hiring, training, mentoring within the DSPV Business Support and Contract Management Team.
• Manage collaboration alignment discussions with the PV Safety Vendor and additional vendors to ensure accurate support and alignment for PV activities.
• Participate in cross-functional activities to ensure and promote compliance with pharmacovigilance data collection standards and operational consistency across Insmed clinical trials and commercial programs.
• Oversee management and maintenance of the DSPV SharePoint repository to ensure that the documents are appropriate, feasible, and operational, and accurately reflect Insmed’ s current procedures and controlled documents.
• Act as a key point of contact between the DSPV and IT Support team to drive the execution of DSPV innovation projects effectively and efficiently in alignment with the overall team vision.

Preferred Qualifications

No preferred qualifications provided.