18 May, 2022
Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.
We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.
At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a fortune 500 company with an international footprint that serves people in more than 140 markets.
It’s going to be an exciting future—come be a part of it!
Associate Director will be responsible for working alongside the Director of Clinical/Medical/CORE Sourcing & Vendor Management in developing and implementing a multi-year strategy that expands the capability and flexibility of working with external partners across the R&D organization at Organon.
Our Clinical Development, Medical Affairs and CORE teams bring new medical advancements to the world by facilitating communications and developing promising new medical interventions that benefit patients. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
What Will You Do
- Build and manage the processes and facilitating the network of resources to support the partners’ ability to execute on sourced scope of work.
- Manage the clinical development/medical affairs/CORE sourced activities to support efficient, on-time execution of regulatory and clinical safety submissions.
- Actively facilitate (and escalation as necessary) of process issues related to the delivery of high-quality, on-time materials.
- Collaborate with 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) of assigned 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 collaborate with 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) and assuring 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 Medical Affairs, Clinical Development and CORE functional teams and Procurement to ensure that we are efficiently and effectively delivering high quality medical communications and clinical information on time globally.
What You Must Have
- PhD/ MD degree or equivalent is preferred; BS/MS is required.
- Experience working in any drug development outsourced model, either on the outsourcer or client side with an ability to translate learnings to a clinical development/medical affairs or outcomes research outsourcing model
- Extensive experience with leading successful delivery of projects (pipeline, business improvement, and/or change management projects)
- Knowledgeable of clinical development/medical affairs 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.
Apply through this Link