Site Name: UK - London - Brentford, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence
Posted Date: Aug 10 2023

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: 02/09/2023

Please note that we reserve the right to close the advert early if we identify a sufficient number of suitable candidates.

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.

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. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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