Senior Manager, Medical Writing (M)- 2249768

Job Summary

The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle management, with support from management as needed. The qualified candidate will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers.

Essential Functions

• Independently preparing PCS, protocols, and protocol amendments often acting as the compound lead
• Lead project management for medical writing deliverable by defining milestones, managing budget, resources and timelines, developing metrics etc.
• Independently preparing all sections of the CSRs, including narratives, working across functional areas to obtain all applicable source material
• Collaborate with cross functional teams like Clinical Research, Biostatistics, Statistical programming, Clin Ops. etc. to ensure alignment on program objectives, facilitate document reviews, proactively resolve any issues etc.
• With minimal supervision, preparing and / or reviewing the clinical sections of submissions documents such as briefing books, Global Investigator Brochures (GIB) and annual regulatory reports
• Prepare and review marketing application submission documents
• At the Director's discretion, may provide work direction to vendors / contractors / consultants
• Contributing to process improvement within and across functional areas by obtaining feedback for improvements for document processes, standards, and structure
• Championing medical writing strategies and processes within and across functional areas
• Continuously work towards improving medical writing capabilities within own area by improving systems / tools and providing training
• Monitoring and evaluating project metrics, escalating issues as needed

Requirements