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.
Executive Director, Strategic Sourcing & Supplier Management (Global Regulatory Affairs and Clinical Safety) North Wales, PA Rahway, NJ Job # R9640
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
This position will be responsible for providing leadership and direction for the planning and oversight for all supplier management activities in support of our flexible capacity model (functional service provider, outsourcing) across the Global Regulatory Affairs and Clinical Safety (GRACS) organization.
The incumbent will leverage relationships with our suppliers to support business needs, execute on business plans and will be held accountable for the performance of these groups. He/she will apply business and management expertise to drive operational performance across GRACS in the supplier management ecosystem, while directing the resolution of highly complex or unusual operational issues. In addition to developing plans to execute on the GRACS supplier management strategy, he/she will negotiate and influence the opinions of both internal and external key stakeholders in the supplier management operating model.
The incumbent is expected to have excellent strategic, problem solving, and critical thinking skills, as well as project leadership with a strong track record of demonstrated success through building strong teams and delivering results. The role will liaise closely with GRACS stakeholders across all functional areas in addition to Research & Development Procurement, IT, Finance, Functional Area representatives as well as resources at the Suppliers. This role requires the necessary regulatory and clinical safety knowledge, business acumen, demonstrated organizational outsourcing experience, negotiation skills, and change management skills to deliver business value to GRACS.
In addition to directly managing a team of supplier relationship managers, this role has oversight accountabilities for external capacity in excess of 250 resources externally with additional growth expected.
Responsibilities will also include: •Delivering the vision and continuously optimizing outsourcing for GRACS •Managing processes and connections between the external partners and the various stakeholders across GRACS, Research & Development, and our Company. •Continuing to build the supplier management capability in order to optimally manage the relationships efficiently and effectively •Understanding regulatory intelligence, technologies, and innovations and their applicability to transforming the GRACS business model •Envisioning future processes and technologies •Exploring approaches used by other industries beyond pharma/life sciences •Conducting rapid project cycles from evaluations through implementation
Primary Activities: •In collaboration with GRACS leadership and functional area partners, establish and maintain an outsourcing vision and posture to achieve GRACS future and current business objectives. •Design and oversee the execution of an implementation plan to achieve and continuously refine our sourcing vision. •Work with procurement, Finance, IT and Functional Area experts to oversee the conduct of due diligence evaluations and selection of external partner organizations. •Direct the build and management of the processes and facilitate the network of resources to support the partner's ability to execute on our sourced scope of work. •Drive external partner innovation in partnership with the functions to deliver tangible process improvements that enable a more digitally enabled GRACS organization. •Establish an industry-leading approach to joint process improvement and innovation across our Company and partner companies for externalized work. •Direct and manage the operational, management governance, and executive relationships between our Company and external partners to deliver on objectives. •Collaborate with internal teams and external parties to ensure best possible delivery of sourced activities according to KPIs and KQIs. Provide regular feedback to management on the performance of partners, ensuring deliverables are met and performance issues are identified, managed, and rectified, and providing regular feedback to partner management and internal teams on performance issues. •Actively collaborate with and provide guidance to partners 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. •Manage and continuously develop a team of our Company professionals that deliver industry leading supplier management
Education Minimum Requirement: •Required: Bachelor's degree •Preferred: Master of Business Administration degree
Required: •Demonstrated experience working in a 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) •Keen understanding of relationship management with demonstrated experience in partnering in large scale situations •Strong negotiation, interpersonal, communication, and leadership skills. •Ability to lead by influence and work effectively in matrix organizational structures •Expert at motivating individuals and teams to manage the change aspects of implementing a new, outsourced model. •At least 10 years in the pharmaceutical industry with at least 5 years in in project management, regulatory affairs, or clinical safety function •At least 5 years managing individual contributors
Preferred: •Regulatory Affair Certification (RAC) or similar certification •Green or Black Belt Certification •Demonstrated experience driving change / transformation projects
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com.
To be considered for this position, please visit our career site at merck.com/careers, search jobs, create a profile and submit your resume for requisition # R9640 to: