Executive Director, Medical Writing

Role Overview

• Oversee the Cardiorenal Medical Writing group, including leading, training, and mentoring for effective performance
• Lead medical writing (including coordination of other Medical Writers) from concept to final product for clinical study protocols and associated forms, protocol amendments, clinical study reports, investigator brochures, and related clinical study documents
• Provide strategic leadership to study teams to direct the preparation of protocols and CSRs, submissions, and other regulatory documents, and associated public disclosure documents.
• Lead medical writing (including coordination of other Medical Writers) from concept to final product for regulatory submissions including IND applications, health agency interaction Meeting Requests, Briefing Documents, and related submissions, NDA/MAA data modules and overall submission packages, and other related documentation for initial and/or supplemental applications for marketing authorization or label expansion
• Demonstrate in-depth knowledge of regulatory writing and data disclosure requirements
• Ensure company SOPs related to document development, templates, and medical writing deliverables conform with regulatory requirements (eg, International Conference on Harmonization (ICH) and other relevant regulatory guidelines). Take ownership of processes related to documents and guide teams through these processes
• Partner with clinical development, biostatistics, and data management in the review and development of tables, figures, and listings (TFLs), and for case narrative planning
• Work closely with study teams to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other data sources
• Project manage the document review process, ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed in a timely and efficient manner
• Ensure documents are generated in accordance with agreed internal processes and standards, are submission-ready, and are appropriately archived in the agreed document management system
• Ensure that appropriate documented quality control (QC) checks are performed on medical writing deliverables, respond to findings, and recommend quality process improvements
• Establish Medical Writing support models and implement strategies to improve operational efficiencies. Suggest or identify modifications and improvements to document preparation processes and company templates to continuously improve quality, efficiency, and productivity. Apply relevant experience in process initiative and/or vendor management

Requirements

• Post-graduate scientific or medical degree (eg, MS, MPH, PhD, PharmD, MD, DO) with 10+ years of experience as a regulatory medical writer within the biotechnology or pharmaceutical industry
• Experienced in medical writing activities for multiple regulatory filings at various development stages
• Experience managing consultants and their projects
• Excellent oral and written communication skills, with the ability to summarize and present complex scientific and clinical data effectively with concise, accurate, and clear narrative flow and syntax
• Proficient in the drug development process, and strong understanding of health authority regulations, ICH guidelines, and medical writing standards, with the ability to interpret and apply these to document writing
• Excellent interpersonal, active listening, and influencing skills
• Strong project management skills, ability to work independently, multi-task, and work effectively under pressure
• Experience with EndNote, StartingPoint templates, and Veeva Vault preferred
• You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies

Tech Stack

• Vault

Benefits

• Market leading compensation
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals
• Comprehensive health care with 100% premiums covered
• no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model
• employees have the autonomy in where and how they do their work
• Unlimited flexible paid time off
• take the time that you need
• Paid parental leave
• 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability
• Subsidized lunch via Forkable on days worked from our office