Associate Director, Regulatory/PV Sourcing & Vendor Management
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!
This position will be responsible for working alongside the Director of Regulatory/PV 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 Regulatory Affairs / Pharmacovigilance team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. 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 regulatory affairs and clinical safety 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.
WHAT YOU MUST HAVE
- Bachelor’s degree or equivalent work experience in pharmaceutical research and development
- Experience working in an drug 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.
- Travel may be required (10-25%)
- Must have proven track record to be able to think critically, strategically, independently and problem solve
- Must have high level of motivation, drive, and demonstration of Organon leadership values
- Excellent written and verbal communication skills including ability to write clearly and concisely
- Top notch interpersonal skills in difficult situations
- Driver of change and innovation
- Ability to work seamlessly with all levels of personnel
- Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations
- Excellent word processing, sharepoint, excel, e-mail, and online meeting tool skills
Who we are …
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.
Our Vision is clear: A better and healthier every day for every woman.
At launch, we will be more than 10,000 Founders strong, ready to rise together as we make a difference in a new way. As Founders, employees will create their future and will help shape the direction of Organon and its impact on the world. Our culture reflects our passion for those we champion.
At Organon, we all belong. We embrace diversity and give it a voice. Our commitment to supporting women is reflected in the make-up of our leadership team, which is majority female and our diversity of experience is core to who we are and what we are designed to do.
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
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