NHS Human Services, Inc.

Reference #: 398710 Site Name: UK - London, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence Posted Date: Jun 18 2024 We're excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we're building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it'll be one of the healthiest workplaces in the world, with best-in-class tech and bright, light spaces to help us thrive.

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery.  We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together. Find out more: Our approach to R&D.

The role is part of the R&D Written Standards and Compliance Learning Organization responsible for simplifying R&D processes and collaborating with Global Process Owners and Subject Matter Experts (SMEs) to streamline and optimize the R&D operating environment. Processes are to be executed in compliance with our procedural documents specifying regulatory and business critical requirements. This role will contribute to the quality and integrity of processes and documents to support successful implementation across R&D. This role will partner with Global Process Owners and Subject Matter experts (SME) across R&D to develop simple and clear procedural documents, and where possible, align them to end-to-end processes. Key Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following... Create a strategy with the Global Process Owner to define the information package required for each process, identifying, and securing the necessary SME resource to simplify and deliver it. Lead projects to create the package of information for a process (or process change) which could include development (or revision) of Standard Operating Procedures (SOPs), Work Instructions, templates, How-to guides, communication materials. The information will be delivered on time and to high quality standards. Lead the contribution of functional area representatives including learning developers and learning systems experts. When appropriate, author documents and lead the comments resolution process and evaluation meetings efficiently and effectively. Ensure consistency of writing style, level of detail and documentation standards. Drive Global Process Owners and SMEs to develop and approve the package of information (including associated training) that describes the process and its operation simply to users while supporting compliance with relevant laws and regulations. Collaborate with all relevant SMEs to ensure the process and documents are fit for purpose and operationally efficient, ensuring business benefit from package delivery. Challenge SMEs on the appropriate level of detail required to ensure processes and documents are simple, clear, and effective for users. Ensure integration of the information into the process landscape by identification of potential overlaps and interactions with other topic areas/processes for resolution by the relevant SMEs and Global Process Owners. Ensure an impact assessment is performed and any resulting actions completed to mitigate the risk to impacted processes from implementing the proposed changes. Collaborate with other Written Standards and Compliance Learning members to facilitate the delivery of a package of information and its accessibility via a one-stop-shop. Partner with Global Process Owners and Quality representatives within Process Governance Boards (Trios) to govern the documentation package for a process to ensure its integrity and simplicity are maintained, escalating any issues that require higher level governance involvement. Proactively seek feedback to continually improve service levels through innovation and increased efficiency in the development and delivery of processes and documents. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Leadership Project management Authoring skills / Medical writing experience Stakeholder management and business partnering Ability to transform the complex into the simple with no loss of meaning or relevance Ability to rapidly establish credibility and trust with experts Highly developed influencing skills Knowledge of drug development processes and regulatory requirements Document management Preferred Qualifications: If you have the following characteristics, it would be a plus: Good Clinical Practice (GCP) knowledge Familiarity with process design and process mapping Awareness of lean sigma / operational excellence (preferred but not essential) Problem solving and root causing of issues Quality mindset

APPLICATION CLOSING DATE: 02/07/2024 Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

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.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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(US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage y