Regulatory Promotion Policy Compliance Manager

This role will require providing support to US Commercial and ViiV Healthcare, US Operations, and US Regulatory Advertising and Promotions staff in governing the enterprise content review/approval/distribution/submissions Standard Operating Procedures framework; mandatory electronic submissions of promotional activities to the FDA; training of staff on said processes, as needed; and Monitoring the process, where applicable, to ensure all functions are proficient and compliant with highly-regulated processes for developing, approving and distributing promotional materials in US Market. Project-related submissions include a range of documents relevant to US applications (INDs, NDAs, BLAs), for 2253 submissions, Advisory Comments and Accelerated approval, together with submission of information required to maintain regulatory compliance for existing biologic and drug marketing licenses.

The role will provide oversight of the electronic Form 2253 submissions process and accompanying promotional items to the FDA (over 4,000 submissions per year). Role is accountable for managing current processes and the end-to-end service model to ensure performance and compliance goals are consistently met against the mandatory electronic technical document (eCTD) submission process for advertising and promotional activities.

The USRA Regulatory Promotion Policy Compliance Manager will help guide process, training, and monitoring to enable the timely completion and submission of Form FDA 2253 and associated assets, as well as other promotional submissions to FDA. This role is accountable for managing workload priorities, promotional filing compliance, and effective matrix relationships with Regulatory Advertising and Promotion Teams, Global Regulatory Publishing, US Ethics & Compliance, US Content Strategy & Operations, and US Commercial Marketing stakeholders across all US Business Units. Additionally, the role includes governance of select promotional compliance processes to include associated Training, Reporting, US Promo Review framework of enterprise Standard Operating Procedures (SOPs), Quality Initiatives, and Controls and Monitoring, as applicable.

The individual will take full accountability and lead all aspects of assigned tasks in support of project deliverables, including ensuring full compliance with GSK process and policy as they apply to the tasks

The job holder will be responsible for:

• Support management and governance of US enterprise Standard Operating Procedures (SOP) framework for the development, review and approval, distribution and FDA submissions of promotional activities.

• Primary oversight of the 2253 process for electronic submissions to the FDA ensuring quality of process and monitoring quality of contributing group deliverables to comply with US regulatory promotional processes and standards:

• Ensuring US 2253, Accelerated Approval and Advisory submissions comply with regulatory guidelines and within required timelines.
• Ensuring operational compliance with archiving of regulatory information in databases, i.e., CARDS, GRACE or Veeva Vault, in conjunction with Publishing.
• Ensure system functionality and a streamlined electronic process to enable accurate and timely completion of promotional submissions to FDA including: 1) Form FDA 2253 and accompanying promotional assets; 2) Accelerated Product Hold submissions; and 3) Advisory submissions, as needed.
• Support oversight of process, performance, and strategy for electronic Common Technical Document (eCTD) delivery of FDA promotional submissions for all US business products and launches.
• Accountable for leading continuous improvement initiatives in support of US regulatory promotional governance priorities and FDA promotional filing processes.
• Enable effective processes and system functionality working with matrix stakeholders.
• Provide training and documentation, as needed, to all roles participating in eCTD processes supporting FDA promotional submissions to ensure ongoing proficiency and compliance.
• Support US Regulatory staff in FDA eCTD filing processes, system functionality, and operational troubleshooting, including performing in regulatory role of complex agency pre-clearance submissions.
• Accountable for optimization and continuous improvement of FDA 2253 process and systems working with Regulatory, Publishing and Commercial stakeholders.

• Accountable for development, stakeholder review, and management of Standard Operating Procedures (SOP) and Work Instruction Documents for appropriate governance of required regulatory processes.
• Accountable for specific Controls and Monitoring processes to ensure compliance with relevant SOPs such as Expiry/Withdrawal and In-Market Deviations; Monitor compliance activities and issue coaching letters; track frequency and managed tiered escalation process.
• Collaborate with stakeholders in Commercial Marketing, Regulatory, Legal, Medical, Content Strategy & Operations, and Ethics & Compliance to develop solutions that ensure compliant process execution.
• Partner with US Regulatory Advertising and Promotion Senior Director to provide training to all Regulatory roles participating in promotional material development to ensure proficiency and compliance, as needed; Provide training to educate enterprise staff on important regulatory compliance procedures and policies such as FDA 2253 Compliance Binder creation, 2253 submissions to FDA, including Pre-submissions for Accelerated Approval Products (i.e., 30-day hold), expiration of materials, Reapproval of assets and general content review/approval/distribution process requirements.
• Prepare and present compliance controls, metrics and deviations reports to governing bodies for informing key business decisions.
• Lead and facilitate In-Market Deviation triage meetings and conduct investigations and analysis to identify the root of a compliance issue and/or In Market Deviations (Quality CAPAs), in order to resolve and provide solutions for process improvements/ risk mitigation, liaising with legal, regulatory, medical, Operations, Commercial Marketing, Process Controls Oversight, and US Ethics & Compliance to address issues.
• Create, revise, and modify company Standard Operating Procedures (SOPs) and work instructions to minimize risk of non-compliance, inform electronic system updates and FDA guidance.
• Partner with Operations on process updates for copy approval and system requirements (Veeva PromoMats - US 'Content Lab').
• Serve as Subject Matter Expert for design, testing and implementation of electronic routing systems, (e.g., Veeva Vault/Content Lab/Smartsheets) as related to FDA Ad Promo submissions; Asset Expiry/Withdrawals, TranSped eSign, select Compliance controls, and Reporting.
• Lead workstreams for eCTD 2253 submissions to the FDA, which include, testing, file requirements, volume assessment, process maps; interface with Veeva Support & Global Regulatory Publishing IT.
• Provide 1:1 coaching and training of US Regulatory staff for FDA 2253 filing process and system troubleshooting.
• Be proficient in digital fluency capabilities to enhance project delivery and drive efficiency and innovation.

Other duties to be assigned as needed:

• Lead In Market Deviation Team for triaging, administration, tracking, metrics, and resolutions for copy approval deviations.
• Assist in evolution of FDA electronic submission filing process - conducting UAT for submissions files in advance of revised processes implementation (other duties as needed).
• Monitor Asset Expiry/Withdrawal reports - manage the process to include Commercial follow up and coaching.
• Assist in compliance training - FDA 2253 and other submissions; Asset Expiry/ Withdrawal; and In Market Deviation promotional process steps.
• Manage Prescribing Information updates from GSK internal system Veeva Vault alongside the Content Lab Support team throughout process cycle, as needed.

• Will contribute to evolution of the Global Regulatory efforts to embed quality and compliance aspects, including level 1 assessment checks, into regulatory processes
  • prepare and present compliance controls, metrics and deviations reports to governing bodies for informing key business decisions.
  • monitor compliance activities and issue coaching letters, track frequency and managed tiered escalation process.
  • conduct investigations and analysis to identify the root of a compliance issue and/or In Market Deviations (CAPAs), in order to resolve and provide solutions for process improvements/ risk mitigation.
  • liaise with legal, regulatory, medical, Operations, Commercial Marketing, Process Controls Oversight and US Ethics & Compliance to address issues.

Competencies and Capabilities

• Proven written and verbal communication skills required to deliver communications with credibility and clarity (concise, well structured, authentic and easily understood) within the GSK matrix environment.
• Sound interpersonal skills
  • Proven ability to effectively network in a matrix environment
  • Involves people in issues that affect them, facilitates dialogue between team members so the links between different ideas and perspectives are understood.
• Capability to work flexibly across different areas of medicines and teams, potentially managing multiple submissions simultaneously.
• Sound problem solving skills
  • Ability to seek information from a broad range of sources, within and outside the normal range of inquiry, to obtain information relevant to a particular task or activity, and to understand wider context.
• Ability to build effective working relationships, aware of the value of new ideas and is open to ideas put forward by others.
• Demonstrates a focus on improving performance and excellence in all tasks; challenges and questions ways of working to seek improved process.
• Ability to interpret and advise on guidelines and requirements as appropriate.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Associates Degree or equivalent experience in Pharmaceutical and/or Regulatory operations.
• Regulatory and/or compliance operations; promotional review, approval, and regulatory submissions requirements.

• 3 plus years of experience working in Pharmaceutical Commercial Operations OR Regulatory Operations.

• Experience in pharmaceutical promotional review and approval policies and processes, including knowledge and/or experience in electronic/eCTD filing, and /or filing of Form FDA 2253 and other promotional submissions (eg, Advisory, Pre-clearance) as a Regulatory requirement.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Knowledge and/or experience in leading and managing the execution of processes, projects, and matrix contributors within a team.

• Knowledge of regulatory agency guidelines and expectations for submissions, and ability to interpret as required.

• Knowledge of Form FDA 2253 submission process in Veeva electronic routing systems.

• Knowledge / awareness of the Regulatory environment, FDA Guidelines, laws and regulations.

• Demonstrated ability for writing of Standard Operating Procedures (SOPs), Work Instruction Documents, and control monitoring.

• Demonstrated ability to develop content and train others on key processes.

• Strong presentation skills; training development and delivery experience.

• Demonstrated ability to manage and troubleshoot process/system complexity.

• Demonstrated ability to influence key stakeholders in matrix environment.

• Demonstrated application of ADP principals to identify opportunities for process improvement and deliver successful solution.

• Strong verbal and writing communication skills; Ability to work independently without direct supervision.

• Completion and submission of Form FDA 2253 and accompanying promotional items to FDA during product launches.

*This is a job description to aide in the job posting, but does not include all job evaluation details.

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

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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).

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