ORGANON - Associate Director, Clinical/Medical Affairs/CORE Vendor Relationship

Job Description

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.

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.

We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

#NEWCO

Search Firm Representatives Please Read Carefully
Organon & Co., Inc., Jersey City, NJ. USA , also known as Organon & Co., Inc., Jersey City, NJ. USA , does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R98969