Reporting to the Vice President, Regulatory Affairs, the North American Publishing Lead, will serve as the NAM publishing leader leading a team of publishers in addition to being a publishing expert to support our operating systems, ways of working with our clients and PLG teams. This role combines deep regulatory operations expertise with strategic foresight, operational leadership, and business development acumen.
The NAM Publishing Lead Consulting position is a remote position. Travel may be required to support client deliverables, company events, and industry events & conferences.
· Expert and Business owner for Systems:
• docuBridge
• EXTEDO
• DXC ToolBox
• Ensures system is updated as necessary and is the Business owner for any risk assessments and or validation activity
· Sets Quality Standards for Team
· Monitors and Actions changes in Guidance and Regulation related to RegOps/ publishing for eCTD submissions work
· Establish acceptable turn-around times for Regulatory Operations Projects
· Develop future state regarding using existing PLG publishing resources and support of Ex-US projects.
· Reviews and approves invoices relating to software systems and licensure
· Develop, Maintain, Facilitate, Lead Training:
• New staff/contactors quality systems / SOPs/ Work Instructions
• Training new staff / contractors / clients DocuBridge / EXTEDO Access and use
Billable Utilization Target
· Meet a target billable utilization of 70% while driving client satisfaction and delivery excellence.
Team Leadership and Talent Development
· Provide line management and performance management to inform optimal resource planning and oversee billable utilization tracking for direct reports.
· Support team capacity planning and utilization trending to ensure optimal resourcing and project delivery across the portfolio of projects
· Coach and mentor and guide publishers, to demonstrate the tools, skills, and resources needed to perform their job responsibilities. Foster a culture of innovation, collaboration, and continuous professional development.
Business Development and Account Growth
· Partner with Business Development leadership to foster the continuation and of strong, long-term relationships with clients and identify expansion opportunities for Halloran services. This includes participation in BD calls as the subject matter expert (SME), contributing and participating in generating a Response For Proposal (RFP), proposal development, BID defense meeting(s), as the SME.
· Build and maintain strong relationships with clients to expand existing client relationships and identify new opportunities through consultative expertise and industry engagement.
· Ensuring that clients are satisfied with the quality of our delivery product.
· Identify new business and expand active accounts through networking, industry events, maintenance of client relationships and professional associations.
Thought Leadership and Industry Impact
· Contribute to thought leadership rainmaking activities to influence and provide perspectives to our industry and clients.
· Generate content (whitepapers, case studies) to showcase expertise and shape industry perspectives.
· Provide presence at industry events, conferences and forums.
· Support the development of marketing materials and social media posts that showcase Halloran’s expertise and breadth of expertise. Other related duties and projects as required and assigned.
Knowledge, Skills and Abilities:
· Bachelor’s degree in scientific discipline with at least 8 years of Regulatory Operations experience in the biotechnology and/or pharmaceutical industry.
· Prior consulting or service provider experience and a demonstrated ability in managing high-profile accounts and fostering client satisfaction.
· Strong leadership skills in line management, coaching, and team development.
· Demonstrated strength in risk management, compliance governance, and process optimization.
· Highly collaborative, with exceptional written, verbal, and interpersonal communication skills.