Medical Writing Asset Lead ClinPharm (Associate Director)

Associate Director Medical Writing Asset Lead Clinical Pharmacology

Are you energized by a medical writing role that allows you to shape operational strategy and accelerate product approvals? Do you have experience in clinical pharmacology?

If so, this Associate Director Medical Writing Asset Lead role could be an exciting opportunity to consider.

As an Associate Director Medical Writing Asset Lead, you will implement operational strategy guided by the Therapeutic Area Head of Medical Writing.

You will apply experience, scientific and operational expertise, and leadership in a matrix organization to provide Medical Writing strategy to one or more therapeutic area assets, to design and deliver high-quality fit for purpose clinical documents including those for regulatory submissions, to plan for efficient and accelerated ways of working, and to contribute to key organizational process improvements.

This is a highly visible medical writing role, that will provide YOU the opportunity to lead key activities to progress YOUR career.

Leadership and Expertise:

• Medical writing lead for one or more medicines and/or vaccine assets throughout the live cycle of drug development, with a focus on clinical pharmacology
• Lead matrix team to deliver 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
• Clinical documents in scope include clinical study protocols, clinical study reports, briefing documents for regulatory authorities, Common Technical Document Summaries (m2.7.1/m2.7.2), clinical overview, ethnic sensitivity analysis reports, responses to regulatory authority questions, clinical sections of the IMPD/IND for clinical trial applications, Investigator Brochures.
• Collaborate with in house, CROs and/or independent contractor medical writers to ensure on-time delivery of high-quality fit for purpose documents. Collaborate closely with g cross-functional groups to understand business needs and clinical data
• Ensure Medical Writing strategy is aligned with the portfolio strategy (e.g., prioritization, acceleration, meeting upper quartile performance). Provide guidance and facilitation to submission teams in development of submission plans. Recommend solutions for problems that affect timelines
• Drive, promote and implement key organizational process improvement initiatives.  Proactively generate 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) and champion novel business solutions in technology and ways of working
• Lead development of training materials for a range of clinical documents.