Manager, Business Support and Contract Management
Insmed IncorporatedAbout the role
Company Description
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.
Recognitions
Consistently Ranked Science’s Top Employer
Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we’ve been named the No. 1 company to work for in the biopharma industry in Science’s Top Employers survey for four years in a row.
A Certified Great Place to Work®
We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.
Overview
Supports the oversight of the Drug Safety and Pharmacovigilance Business Support and Contract Management Department services and DSPV business partner relationships according to ICH-GCP and GVP guidelines, regulatory requirements, Insmed SOPs, and/or project specific procedures. Focuses on alignment of process between external vendors, supports process improvement through identification and implementation of new or revised processes, supports the VP, DSPV through management of critical departmental timelines and with budgets for internal and external spend, manages invoices and budget related activities for DSPV Vendors, supports Insmed QMS. Manage DSPV Contracts and invoices with PV Vendor, maintain vendor contact, monitor procurement, and address invoice issues promptly.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.
- 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
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