Hybrid Director, Business Development Execution – Regulatory Affairs

at MSD

• Job title: Director, Business Development Execution – Regulatory Affairs
• Job type: Full Time
• Experience level: Lead
• Salary: $169,700 - $267,200 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Rahway, United States

About the role

• Director managing GRACS Business Development Execution for pharmaceutical company. Coordinating regulatory activities and ensuring compliance with business development agreements.

Responsibilities

• 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
• Facilitates the processes, communications, and governance to ensure GRACS contractual obligations and commitments are met while maintaining regulatory compliance
• Work closely with the Corporate Business Development, our Company's Research & Development Division Global Alliance Management (MGAM), Integration Management Office (IMO) and GRACS Business Development to understand the partner agreements and the goals of those agreements throughout the lifecycle post signing
• Following the GRACS Business Development Operating Model, performs all responsibilities of the GRACS Business Development Execution Lead including facilitation of discussions with GRACS SME execution team to identify gaps and risks, track progress and coordinate ongoing updates of progress to ensure GRACS Leadership is informed as needed
• Responsible for understanding contracts and working closely with the Corporate Business Development and our Company's Research & Development Division Alliance Management Teams
• Assess GRACS Integration related 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
• 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
• Develop the functional alliance relationship to support effective 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
• Work closely with the Mature Deals and Operations team 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
• 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

Requirements

• BS Degree preferably in technical, business or science
• At least 12 years in the pharmaceutical industry with at least 5 years in Regulatory/Pharmacovigilance Function or Business Development
• Proven and demonstrated skills in project management and leadership
• Strong virtual and in person collaboration
• Clear communicator and goal oriented
• Comfort and experience building and presenting effective slide presentations with audiences at all levels of the organization
• Highly organized, motivated, and detail-oriented while still able to keep overall 'big picture' view of projects and strategies
• Demonstrated analytical and data management skills
• Experience pulling together abstract milestones and data into centralized management report
• Demonstrated ability to lead cross functional teams and facilitate cross functional meeting to achieve a purpose
• Strong, demonstrated project management capabilities and skills
• Ability to communicate messages in a clear and concise manner both verbally and in writing
• Experience with change management concepts and execution
• Strong proficiency with generating content using all MS Office tools including but not limited to Word, Excel, Power-Point and SharePoint
• Some experience creating and modifying MS Teams and MS Project or related tools to manage project timelines and collaboration

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days