Position: MRL Project Manager
Location: Rahway, NJ
Duration: 9 Months

Focus:

• Project Management, but not IT projects.
• Need Operational experience
• PMP certification is desirable
• Change management experience
• Sigma certification is desirable
• Regulatory experience
• Pharmacovigilance licensing experience
• Alliance management experience
• Multiple project handling experience
• Change management experience
• Implementing contracts which are already developed.
• Someone who has worked as a Project leader/Project Manager or in any leadership role
• Facilitation experience
• Execution experience

Responsibilities:

• 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 (Client) 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.
• Partner with Business Development Leads responsible for Client 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 Client. This includes influence on the external parties as well as internal to Client – the executive level management, across divisions, and across countries.
• Upon execution of assigned Business Development agreements, ensure communication, and implementation within GRACS functional areas as deals require.
• 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.
• 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, labelling updates, pharmacovigilance.

For all assigned Business Development Agreements

• 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 behavioural protocols to encourage collaborations as well as review committees to facilitate decisions and oversight deal's execution.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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 Client 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.