Medical Writing TA Lead (Vaccine & Infectious Disease)

Job Purpose

Apply leadership, experience, scientific and operational expertise in a matrix organization to provide Medical Writing Strategy to complex or multiple Therapy Area assets, the design and delivery of high quality fit for purpose clinical documents including those for regulatory submissions, the plans for efficient / accelerated ways of working and key organisational process improvements.

Key Responsibilities

• Lead and manage a MW TA team for delivery a range of capabilities as required by the TA for clinical documents through the development lifecycle in line with the regulations of Japan and China.
• Drive collaboration across TAs in Asia MW as well as among China, Japan and Global MWs. Promote leadership behaviours that support GSK values.
• Establish quality, efficiency and effective teamwork across all document teams.
• Drive Medical Writing strategy to ensure alignment with the portfolio strategy (e.g. prioritization, acceleration, meeting upper quartile performance).
• Lead TA aligned collaborative ways of working by ensuring that TA Asset Leads lead matrix team to drive the delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data and are in line with GSK standards and global / regional / local regulatory requirements, while demonstrating high performance standards for own work and encouraging similar standards across the matrix teams.
• May lead one or more assets and serve as a medical writing point of contact for this / these assets. Support prioritising workload across an asset(s) to deliver MW portfolio.
• Lead and drive key organizational process improvement initiatives by proactively generating ideas for simplification and improvement taking advantage of opportunities that arise. Promote environment for others to generate ideas for improvement (e.g., continuously challenge the status quo, leverage digital tools to enhance efficiency, etc.) and champion novel business solutions in technology and ways of working.
• Provide mentoring, coaching and / or training to individuals or teams to develop others and shared learnings. Lead development of training materials for a range of clinical documents.
• Provide resourcing proposal to MW Asia Head to contribute to budget forecast with early escalation of risks and opportunities to ensure optimal resource utilization. Drive flexible resource allocation including short-term support to MW in other TAs.
• Build interactive relationships with team leaders and senior stakeholders.
• Lead external resourcing and CRO interactions for project resourcing agreements. Implement third party resourcing agreements and oversee contract medical writers for document delivery.

Qualifications :

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.

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