Associate Director, Global Regulatory Affairs and Clinical Safety, External Operations / Supplier
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
This position will be responsible for working alongside the Head of External Partner Operations in developing and implementing a multi-year strategy that expands the capability and flexibility of working with external partners across the GRACS organization at Merck. This will include developing and supporting outsourcing of work across GRACS areas to be determined.
This position will be responsible for directing the activities in support of our current (and future) outsourced scope of work.. Responsibilities will include managing processes and connections between the external partner and the various stakeholders within MRL including Global Regulatory Affairs and Clinical Safety (GRACS) Functional Area Managers, GRACS-Leadership and the regulatory and clinical safety teams to ensure that we are efficiently and effectively delivering high quality regulatory and safety submissions on time globally. Additionally, the incumbent will need to have a close working relationship with Procurement as part of effective execution of the sourcing management process.
The incumbent will require a working knowledge of and skills in regulatory affairs, clinical safety, business operations, outsourcing, and project and change management with a strong track record of demonstrated leadership.
- Building and managing the processes and facilitating the network of resources to support the partner’s ability to execute on our sourced scope of work.
- Managing the regulatory and clinical safety books of business and schedules of sourced activities to support efficient, on-time execution of regulatory and clinical safety submissions.
- Establishing and managing the relationships between Merck and external partners to deliver on objectives.
- Active facilitation (and escalation as necessary) of process issues related to the delivery of high-quality, on-time materials.
- Collaborating 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 collaborating 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.
- Facilitate the collection and development of business requirements with the cross-functional regulatory team and external business partners.
- Support of annual business planning and the analysis and proposal of the annual financial plan related to external partner expenditures.
- 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 4 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.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to firstname.lastname@example.org.
Visa sponsorship is not available for this position.
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Job: Regulatory Affairs Generic
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck