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

• Bachelor's Degree required; an advanced degree in science or related areas is preferred.
• 8+ years of experience in pharma or related industry OR equivalent combination of education and experience
• Experience writing/reviewing clinical regulatory documents and submissions for own area of study/ program/ marketing application, with direction
• Experience managing multiple projects by creating plans for budget, resources, milestones and collaborating with cross functional teams to drive accountabilities
• Experience in vendor management
• Proven performance in earlier role/comparable role
• Strong critical thinking and problem solving skills
• Self-motivated with the ability to influence others
• Able to attend on site meetings as necessary
• Advanced working knowledge of MS project and MS Word and Experienced in the use of a document management system