• Job Description

  Req#: 370498

  Job Purpose:

  • Provide leadership to align Medical Writing capabilities, priorities and resource management in Medical Writing, with business and operational needs for Research and Development Centers for competitive delivery of our pipeline.
  • Collaborate effectively with contacts at the R&D Centers (e.g., Medical Writing TA Head and Asset Leads) to ensure clarity in project work scope and need.
  • Ensure the Medical Writing Team have the capability to provide 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.
  • Support the range of regulatory documents in scope including those that are study-based (e.g., protocol,
  • clinical study report) and above/cross-study (e.g., Investigator Brochures, clinical summaries). These
  • documents are used by clinical investigators, ethics committee and regulatory agencies.
  • Lead and align with key organizational process improvement initiatives and champion improvements in
  • ways of working. Proactively generate ideas for improvement and promote environment for others to generate ideas too.

  Key Responsibilities:

  • Manage a team of 8-10 in-house medical writers to develop the clinical regulatory documents in scope to support delivery of the portfolio. Identify needs for development and for team members to expand their competence and capability in generating documents and working effectively with colleagues in the central teams. Set annual objectives to meet writers' capabilities, development potential and business needs. (People Management/Development)
  • Ensure medical writers are trained in relevant procedures, policies and standards to be applied for Pharma and Vaccines Clinical R&D writing activities. Lead development of training materials for clinical documentation, and provide mentoring, coaching and/or training to individuals or team. Promote best writing practices and build capability (GCP standards, Process development, application and alignment).
  • Evaluate resources required for Medical Writing activities to ensure alignment with the Development's strategic and operational objectives. (Setting priorities and resource management)
  • Interface with the Medical Writing TA teams, other functions and third parties, as required, to ensure appropriate input from and alignment with stakeholders for the resourcing and generation of clinical regulatory documentation in scope. (On-time delivery with quality)
  • Drive and implement key organizational process improvement initiatives. Proactively generate ideas for improvement and promote environment for others to generate ideas (e.g., for accelerated, simplified
  • processes); champion improvements in technology and ways of working. (Process improvement)
  • In collaboration with the Medical Writing CoE Head and leadership team, measure and monitor efficiency and quality of the Medical Writing team’s output on the Medical Writing function (On-time delivery and quality).

  Minimum Level of Job-Related Experience Required:

  • 6-10 years’ experience in hands-on regulatory Medical Writing including leading the development of clinical study reports and submission documents in a clinical setting within the pharmaceutical industry.

  Minimum Level of Education Required:

  • MSc Life-science The role will require understanding of complex regulatory

  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.

  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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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• About the company

  GlaxoSmithKline plc is a British multinational pharmaceutical company headquartered in Brentford, England.

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