Back to jobsLead the Medical Writing efforts and strategy on drug development programs and ensure high quality and on-time writing deliverables in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs), including clinical protocols, amendments, investigator brochures, clinical study reports, summaries of biopharmaceutics, clinical pharmacology, clinical safety, and clinical efficacy, clinical overviews, and related documents.
Directly oversee, develop, and manage medical writers on multiple programs; provide leadership, coaching, guidance, and mentorship; ensure management and training of external writers/CROs.
Communicate program goals and priorities to the medical writers on assigned drug development programs.
Plan, coordinate, oversee, and drive clinical filing dossiers with colleagues from the Filing Excellence group.
Independently plan, write, and edit high-quality and on-time writing deliverables, as needed.
Contribute to the development of global department standards (including templates, style guides, and related processes) and implementation of process improvements.
Collaborate with Medical Writing leadership to ensure proper planning and resourcing for upcoming project writing deliverables.
Partner effectively with Data Sciences and Statistics, Clinical Operations, Clinical Development, Regulatory Affairs, Global Patient Safety and Risk Management, Early Development, Program Management, Research, and Quality, as well as with external stakeholders.
Serve as subject matter expert for Research and Development documents and their production, including clinical document strategies within the drug development program.
