Organon - Associate Director, Regulatory & Pv Vendor Relationship Management Job in Msd Pharmaceuticals Private Limited

WHAT WILL YOU DO:

• Build and managethe processes and facilitating the network of resources to support the partners ability to execute on sourced scope of work.
• Managethe regulatoryaffairsand clinical safety sourced activities to support efficient, on-time execution of regulatory and clinical safety submissions.
• Activelyfacilitate(and escalation as necessary) of process issues related to the delivery of high-quality, on-time materials.
• Collaboratewith internal teams and external parties to ensure best possible delivery of sourced submission work through clearly defined objectives and actively managing and tracking overall performance (via metrics) ofassigned vendors. This includes providing regular feedback to management on the performance of vendors, ensuring deliverables are met and performance issues are identified, managed, and rectified, and providing regular feedback to vendor management and internal teams on performance issues.
• Actively collaboratewith and providing guidance to vendors to assure new capabilities and services are developed and existing capabilities and processes are assessed and improved (on an ongoing basis) andassuring consistent application of roles and processes across projects.
• Support of annual business planning and the analysis and proposal of the annual financial plan related to external partner expenditures.
• Managing processes and connections between the external partner and the various stakeholders within R&D including Global Regulatory Affairs and Pharmacovigilance functional teams and Procurement to ensure that we are efficiently and effectively delivering high quality regulatory and safety submissions on time globally.

WHAT YOU MUST HAVE:

• Educational background of candidates with PhD / MD or equivalent degree is preferred.
• Experience working inanydrug development outsourced model, either on the outsourcer or client side with an ability to translate learnings to a regulatory and clinical safety submissions outsourcing model
• Extensive experience with leading successful delivery of projects (pipeline, business improvement, and/or change management projects)
• Knowledgeable of regulatory, CMC, and global safety processes for pharmaceutical products, vaccines and/or biologic products.
• Strong negotiation, interpersonal, communication, and leadership skills.
• Ability to lead by influence and work effectively in matrix organizational structures
• Expert at motivating individuals, teams to manage the change aspects of implementing a new, outsourced model.
• At least 7 years of working experience with or within a healthcare/consumer care industry project management, regulatory affairs, or pharmacovigilance function that includes working with external partners.