Project Manager - MRL ONLY

34455

Education: • BS Degree/MS degree in any field. Required Experience: • At least 12 years in the pharmaceutical industry with at least 5 years in Regulatory, Pharmacovigilance/Licensing and/or MRL • Ability to influence and effectively operate in an ambiguous/rapidly changing environment while being quality and compliance oriented. • Proven and demonstrated skills in project management and leadership, strategic, proactive, and a creative problem-solver that generates options and drive results in a deadline driven environment. • Experience managing cross-functional teams and track record of effective collaboration with noted ability to lead by influence and work effectively in matrix organizational structures. • Well-developed effective collaboration, facilitation and leadership skills; able to establish cooperative team environments. • Demonstrated ability to effectively drive decisions making across organizational levels and disciplines. • Highly organized, motivated and detail-oriented while still able to keep overall "big picture" view of projects and strategies. • Proficient in MS Office tools including but not limited to Word, Excel, Power-Point and SharePoint. • Experience creating and modifying MS Teams and MS Project or related tools to manage project timelines and collaboration. • Proficient in conducting on-line communications and meetings with business partners in accordance with Merck IT guidelines. • Technically skilled in process improvement methodologies (e.g. PMP, Six Sigma, or Change etc.) and associated toolsets. • Demonstrated sensitivity and knowledge of Diversity and Inclusion principles. Note: Travel between: Rahway and Upper Gwynedd for meetings when needed. Hybrid role. Position can be located in Rahway, NJ / Upper Gwynedd, PA. Hours can be 8am-5PM EST. Functional Area: Regulatory Affairs (MRL, GRACS) Division/Area: MRL, Global Regulatory Affairs and Clinical Safety Quality & Compliance (GRACS) Department: Business Development, Partner, and Supplier Management Reports to: Senior Director, Business Development Execution Brief Description of Position: Under the minimal guidance of the Senior Director, Business Development Execution, the incumbent manages and is responsible for the business process and related activities associated with Global Regulatory Affairs and Clinical Safety (GRACS) Business Development Execution. The primary function includes coordinating various GRACS functional areas, to ensure implementation and maintenance of regulatory activities associated with assigned Company Business Development (BD) Agreements. These agreements include but are not limited to divestitures, mergers/acquisitions, in-licensing, out-licensing, collaborations, public private partnerships, distribution, co-marketing, and authorized generic agreements. Facilitates the processes, communications, and governance to ensure GRACS contractual obligations and commitments are met while maintaining regulatory compliance. 1. Partner with Business Development Leads responsible for Merck negotiations with external partners and agreements activities that have GRACS organizational impact. Support the definition of the right strategy and approach with the partner to ensure global regulatory compliance for Merck and/or MSD. This includes influence on the external parties as well as internal to Merck – the executive level management, across divisions, and across countries. 2. Upon execution of assigned Business Development agreements, ensure communication, and implementation within GRACS functional areas as deals require. 3. Collaborates with all functional areas as well as Business Development Partnership and Supplier Management, Clinical Research, Legal, Alliance Management, and Manufacturing as deals require to identify detailed obligations of each agreement and develop strategies to accommodate such requirements as efficiently as possible. Ensure and/or facilitate assessments to evaluate the organization’s ability to meet those business development execution strategies. 4. Assist in the identification and prioritization of agreements to maintain compliance with worldwide regulatory requirements including but not limited to post-marketing commitments/requirements, renewal regulations, labeling updates, pharmacovigilance. 5. For all assigned Business Development Agreements a) Act as a project lead and point of contact that require functional area deliverables related to implementation and maintenance across GRACS. Anticipate internal/external business and regulatory compliance issues, assess problem situations to identify causes, gather and process relevant information, generate possible solutions, make recommendations and/or resolve the problem and direct the resolution of complex business problems. Develop and manage the project plan and facilitate related status meetings. Ensure adherence to the established governance structure including roles and responsibilities and behavioral protocols to encourage collaborations as well as review committees to facilitate decisions and oversight deal’s execution. b) Ensure adherence to the established common network framework for GRACS functional areas to understand/evaluate business partner operations, establish guidelines for working together and leverage differences to create value, share best practices and deliver activities to drive knowledge transfer between GRACS team members. Provide training as necessary on successful partner relationship skills including process, collaboration, communication, and tools. c) Ensure establishment and monitoring of meaningful performance indicators associated not only to deal objectives but also to the progress or factors that will affect the ultimate performance (leading indicators) and establish mechanism to guarantee frequent review of the organization’s own data to enable assessment of current performance and identify where early efforts can be made to improve future quality/process scores. d) Treat the various agreements as a living document ensuring feedback and collaboration with Business Development, Legal, and/or Pharmacovigilance Licensing & Business Development for the deal life cycle management. 6. When alliance relationship is required in support to the business deal execution, engage partners and GRACS applicable personnel to explore the potential challenges of working together, examine differences, develop shared protocols for managing those differences, and establish mechanisms for their day-to-day work. 7. Responsible to define, establish, and drive continuous improvement of the Business Process for the pre and post execution phases of Business Development Agreements with focus on how the different GRACS functions and business partners collaborate. 8. Specific to opportunities where an ongoing relationship is maintained with the business partner, the incumbent will be responsible for serving as the point of contact for all alliance management issues related to ongoing GRACS activities. 9. Interact closely with the business system owner for the maintenance of the Business Development Lifecycle Management system used for extraction of key fields from executed contracts and accessed for partner notifications. 10. The Director may also have people management responsibilities related to oversight of team members in supporting opportunities in a similar manner as described above. Additionally, the incumbent will assume the responsibilities for employee development and management consistent with Company Leadership and Diversity and Inclusion principles.

Two Companies, One Partnership.
AgileOne is proud to be responsible for placing temporary employees on assignment at Merck & Co. We are always looking for talented people who can bring their empathy, creativity, organization, and other skills to Merck. It is these unique skills that contribute to their company purpose of saving and improving lives around the world. Please join us as an AgileOne temporary employee on assignment at Merck —and start making your impact today!

EEO Employer Verbiage:

About Us
AgileOne is headquartered in Torrance, California, and is the Global External Workforce Solutions Provider for Merck & Company. Our temporary employment opportunities are perfect for highly skilled professionals who want to make an impact at a top-tier company, without committing to a long-term employment relationship! When you join one of our projects, you’ll take on exciting work with our client. Merck is a global leader, and their products are found in 79% of countries worldwide. They have approximately 68,000 employees.

Employee Benefits
While on temporary assignment at Merck, your employer of record and employee benefits are through AgileOne. At AgileOne, we invest in employee development and wellbeing. Our corporate culture rewards productivity, world-class customer service, and creative approaches to problem solving. Some of the employee benefits include:

• Weekly compensation!
• Medical, dental, and vision insurance
• 401(k) and Flexible spending account (FSA)
• Employee recognition programs
• Career development opportunities
• Life & disability coverage

Diversity & Inclusion
The ActOne Group bears the distinction of being the largest, zero-debt, certified woman/minority-owned workforce management company in the United States. AgileOne strives to offer each employee an inclusive, respectful, and engaging work environment that celebrates the wide range of talents they bring to our organization.

Corporate Social Responsibility (CSR)
Giving back to the local communities is a fundamental part of AgileOne. We pay it forward by encouraging our employees and teams to lend their time and talent. We have a strong history of supporting the following causes:

• Local food banks and rescue missions
• AIDS Walk Los Angeles
• Run from Hunger
• Just in Time for Foster Youth

Diversity of talent. Diversity of thought. Diversity of background. Many experiences: ONE voice.
AgileOne is an Equal Opportunity Employer