Manager, Business Development, GRO

Job Purpose:

The role of the Business Development Team is to establish and embed a fully harmonised global team supporting the execution of regulatory operational business development (BD) strategies and activities, including diligence, integration, and divestment across all modalities and taxonomies (e.g., Clinical, Nonclinical, Quality and Regulatory) enabling the delivery and support of Regulatory Information Management (RIM). This includes:

• Enabling the execution of the various regulatory processes (including maintaining awareness of evolving external environment driving greater need for structured data)

• Ensuring the timely update of compliant data and adherence to record keeping requirements

• Delivering data quality and integrity whilst continuously seeking innovative opportunities to improve ways of working, business efficiency and drive automation

The information (data and documents) managed by BD is critical to patient safety, regulatory compliance and effective business operations. The position holder is accountable for the quality and accuracy of their own work and for the support of the large number of other users across GSK and our BD partners. The position holder will inform stakeholders on best practices with regards to global regulatory systems and processes and (on a continuous basis) will feed back suggestions for improvement.

Key Responsibilities:

• Engage with teams of geographically dispersed BD stakeholders, enabling the creation, curation and stewardship of Regulatory Information for integrations, reversions and divestments in accordance with defined Business Development Plans / Service Level Agreements.

• Support (or lead) the assessment of the regulatory operational capabilities of acquisition partners and manage the integration of regulatory information (data and documentation) into GSK's systems, such as Veeva Regulatory Vault, eArchive, etc.

• Creation and maintenance of Regulatory Information within the company's Regulatory Information Management (RIM) system with information provided 'on demand' from diverse business development partner companies- typically supporting urgent 'timebound' integration plans.

• Monitoring data quality routinely to identify and mitigate issues against agreed BD validation criteria. Additionally, conducting root cause analysis and trend analysis to identify appropriate corrective/preventative actions to drive optimization of BD E2E processes. Preparation of BD Data Transfer Reports (DTRs) in compliance with the GSK DTMS framework.

• Recognized as a Subject Matter Expertise in Regulatory Information Management Systems and Processes, requiring an expert level understanding of the Regulatory Vault data model, taxonomies, reporting and analytics.

• Accurate completion of more complex or non-routine data maintenance tasks to an agreed schedule.

• Ensure own work and that of junior colleagues is compliant with data standards and defined procedures

• Routine/ ad-hoc extraction and transformation of raw data from various Regulatory Information Management (RIM) systems for KPI generation in the context of data quality improvement and performance monitoring

• Ensuring continuous improvement (process & system) culture within the team for the benefit of GRA. Ensure understanding of upcoming system changes, propose changes and support the implementation of those changes within RIM.

• Ability to support RIM projects, activities, and tasks on an as needed basis.

Why you?

Basic Qualifications:

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

• Bachelor's degree in Scientific or Technical discipline.

• 6+ years of experience in Regulatory Information Management (RIM) AND/OR previous work experience in a customer-facing role utilising databases within a regulated or quality-critical environment.

• Experience working independently Regulatory Information management in a multinational environment.

Preferred Qualifications:

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

• Project management skills, overseeing and prioritizing multiple activities

• Good analytical skills and process thinking

• Good team player within multi-cultural environment

• Service/customer-oriented attitude and ability to interact effectively with all levels of personnel with all levels of personnel in an interdisciplinary and matrix environment

• Excellent written and verbal communication skills and ability to present information in a clear and concise manner

• Good understanding of the role and responsibility of Registration Information Management

• Attention to detail, excellent organization and time management skills

• Awareness of standard submission formats, with ability to navigate submission content plus awareness of system validation methodology

• Has strong sense of urgency, able to effectively prioritize such that key issues or emerging high priority matters are handled in a timely and effective way

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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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