GlaxoSmithKline is hiring: Director, Submission Delivery Excellence - Publishing
GlaxoSmithKline, Collegeville, PA, United States, 19426
Posted Date: Feb 25 2025
Job Purpose
The Director, Submission Delivery Excellence, Publishing position holder(s) will be accountable for leading a team of Regulatory Submission Publishers to meet GSK's Investigational Drug Development, New File Registration, and Lifecycle management Objectives and Regulatory compliance obligations.
This is a strategic position which involves influencing stakeholders at all levels within GRA and driving harmonization and business change activities across a broad customer base, in addition to ensuring on time and quality delivery of submissions for R&D development and lifecycle products.
In this role, the position holder will be responsible for: ensuring timely delivery of compliant Regulatory submission packages through the provision of expert guidance on the Regulators’ technical requirements to R&D Project Teams; planning and directing Publishing work across a large resource pool at GRO global locations; and leading cross-divisional change initiatives which ensure GSK is able to maintain compliance with emerging Authority requirements in the e-submission space.
The Director, SDE Publishing, will work collaboratively with stakeholders to agree on priorities and implementation timelines for Regulatory submissions globally to maximize the business value from a GSK perspective while meeting Regulatory Authority requirements. This role will include leadership within and across enterprise matrix teams including GRA, GRO, and contributing departments (e.g. Clinical Operations, Data Management, Stats and Programming) as needed to meet submission delivery expectations.
The position holder will be a member of R&D Regulatory Submission Matrix teams for critical new products and expanded indications and will need to interface and negotiate with a wide range of stakeholders to ensure that R&D pipeline objectives are met, particularly in very late-stage Development. This position holder needs to demonstrate technical expertise along with astute matrix management and negotiation skills in highly pressurized stages of the medicine’s development process.
This role will provide functional leadership for the team with direct and indirect reports in multiple locations.
Key Responsibilities
- Lead a team of Global Publishing Leads (GPLs) who will be responsible for leveraging detailed submission requirement knowledge and technical capabilities to deliver fit for purpose and quality submission packages per agreed schedules.
- Precisely and consistently follow Regulatory System processes which are aligned to GRA SOPs, Work Instructions, and How to Guides.
- Guide Regulatory Matrix Teams on the optimum strategy for creation of submission content in regulated systems for complex product applications. Negotiate agreements with R&D stakeholders, including more senior leaders, on specific technical aspects of major submissions and timelines for delivery which best support the needs of the R&D Project.
- Act as the point of contact for R&D project teams for resolving technical issues with electronic submission deliverables raised by Regulatory Agencies and interact with Agencies as required.
- Drive best practice and continuous improvement of systems and processes.
- Collaborate with Submission Delivery Excellence colleagues and stakeholders to continuously improve the effectiveness and efficiency of the function.
- Ensure training and development of Publishing staff in accordance with GRA standards, as well as requirements established by Regulatory Authorities.
- Partner with colleagues in the Regulatory Asset Oversight team to identify and remove barriers that will prevent a successful outcome on submission delivery targets.
- Definition of meaningful metrics and KPIs to assess individual and team performance.
- Establish a culture and framework for staff development. Identify key talent and provide appropriate stretch objectives and growth opportunities.
- Maintain a network amongst industry peers, vendors, and Regulatory trade associations for awareness of best practices and future opportunities.
Minimum Requirements
- Bachelor's Degree in life sciences
- Has led the processing of submission content and publishing across a range of major submissions as an integral member of Regulatory Project teams.
- Has extensive experience (7+ years) of Pharmaceutical Regulatory Affairs covering a breadth of global regulatory procedures, particularly those related to electronic submission and data standards.
- Experience (5+ years) working with RIM systems within a regulated environment.
Preferred Requirements
- Ability to manage and motivate matrix teams in a globally diverse organization.
- Demonstrated ability to define and implement new processes with an agile mindset that promotes a culture of continuous improvement.
- Demonstrated Project Management skills, overseeing and prioritizing multiple activities across one or more sites for multiple customers.
- Expert knowledge of current Publishing technologies.
- Proven Line Manager and experience coaching and mentoring direct and non-direct reports.
- In-depth knowledge of relevant regulations and standards relating to the submission of regulatory applications worldwide.
- Ability to work well both independently and within a team to ensure on-time delivery of objectives/projects.
- Demonstrated ability to think flexibly to meet constantly shifting priorities and timelines, including when under late-stage development pressures.
- Project management skills, overseeing and prioritizing multiple activities across one or more sites for multiple customers.