Director, Submission Delivery Excellence - Publishing Job at GlaxoSmithKline in

Site Name: USA - Pennsylvania - Upper Providence, UK – London – New Oxford Street
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 following 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. Negotiates 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.
• Establishes a culture and framework for staff development. Identifies key talent and provides appropriate stretch objectives and growth opportunities.
• Maintains a network amongst industry peers, vendors, and Regulatory trade associations for awareness of best practices and future opportunities.

Why You?

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 system 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.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

#J-18808-Ljbffr