R&D Senior Manager

Job Summary

The R&D Senior Manager will report to the Head of R&D Scientific Affairs, IBSA Group.

Key Activities

• Work directly with United States vendors) and parent company Drug Safety to facilitate processing and reporting of adverse drug experiences (ADEs)
• Proactively identify opportunities for process improvement
• Manage/contribute to the creation, revision and/or maintenance of regulatory documents that support investigational (IND and IDE) and marketing application (ANDA, NDA, 510(k), PMA, etc.) filings
• Submit regulatory and safety packages to the United States Food and Drug Administration (FD) through the Electronic Submissions Gateway (ESG), as well as track and communicate successful submission(s) to applicable stakeholders
• Proactively ensure regulatory compliance within the organization
• Manage assigned clinical and/or nonclinical programs
• Coordinate collection of functional documents from internal and external stakeholders, as applicable
• Author routine regulatory correspondence
• Implement applicable internal Manuals, Standard Operating Procedures (SOPs), Work Instructions and any external collaboration agreements
• Assist with creation and maintenance of applicable Manuals, SOPs and Work
• Provide support to other business functions, including, but not limited to, medical affairs, quality and marketing
• Contribute to creation and maintenance of drug listing forms
• Complete regulatory forms (Form FDA 1571, 356h, etc.)
• Participate in strategic planning of development programs
• Coordinate and/or manage publishing of regulatory and safety submissions with applicable United States vendors)
• Liaise with, and/or manage in a task-specific manner, United States vendors (including Contract Research Organizations (CROs)), IBSA (US) Regulatory Affairs and internal stakeholders to support business objectives
• Work directly with United States vendors and parent company Quality Assurance to resolve product quality complaints
• Regular teleconferences (TCs) with Corporate R&D Scientific Affairs team
• Manage/contribute to the creation, revision and/or maintenance of clinical trial documents, including, but not limited to, the protocol, Investigator Brochure, Clinical Trial Agreements, and Informed Consent Form
• Contribute to creation and maintenance of product regulatory history documents

Overall Project Management activities will include the following:

• Payment's administration: review of invoices sent by CRO/Vendors and recommendation to approve or not the invoice
• Support eCRF Design and Validation process, including eCRF User Acceptance Test
• Act according to IBSA SOPs and Processes
• Support in Investigators/ Monitors Meeting organization, if requested
• Support Auditors in case of study site audit, if requested
• Training of Investigators/site staff on study specific aspects and co-monitoring if needed
• Review of the EC/IRB submission package preparation (including amendments to original submission, continuing review, close-out) and support for the entry of the study information in regulatory portal (e.g. clinicaltrials.gov, others), if needed
• (UAT) with the involved vendor
• Review of the site selection process (e.g. feasibility forms), sites budget and negotiation process, review of the clinical trial agreement (CTA)
• Regular teleconferences (TCs) with CRO: first point of contact for CROs and other US vendors
• Regular teleconferences (TCs) with Corporate R&D Scientific Affairs team
• Reviews of Monitoring Visit reports and any related documents, after CRO PM first review; Monitoring visit plan management
• Review of Clinical Study Report and appendices
• Study documents review when applicable (i.e., Protocol, Protocol Amendments, PIS&ICF, and other study documents and forms)