Associate Director Of Medical Writing

Overview

• Lead strategic and operational medical writing activities for clinical development programs, ensuring high-quality regulatory documents.
• Collaborate with cross-functional teams to align messaging and mitigate risks for successful regulatory interactions and filings.
• Provide hands-on writing expertise while managing resource planning and matrix leadership responsibilities.
• Develop and execute document strategies for complex regulatory submissions, ensuring alignment with program objectives.
• Contribute to departmental goals, including process improvements and adoption of new tools and technologies.
• Operate in a hybrid work environment with a flexible onsite and remote schedule.
• Support marketing authorization applications, IND submissions, and other major regulatory filings.
• Apply advanced technical judgment to solve complex problems and ensure cohesive messaging.

Key Responsibilities & Duties

• Accountable for medical writing deliverables, ensuring aligned timelines, quality, and resourcing.
• Independently author and lead planning, review, and delivery of clinical and regulatory documents.
• Coordinate clinical content development for complex regulatory submissions, ensuring alignment with strategy.
• Serve as the primary medical writing lead on program teams, proactively identifying risks and driving resolutions.
• Oversee outsourced writing support, managing review cycles and ensuring inspection-ready quality.
• Contribute to departmental goals, including process improvements and adoption of new technologies.
• Collaborate with Clinical Development, Regulatory Affairs, and Biostatistics teams to ensure cohesive messaging.
• Lead initiatives to enhance inspection readiness and optimize resource utilization.

Job Requirements

• Advanced degree (PhD, PharmD, or equivalent) in a relevant discipline required.
• Minimum of 8 years of experience in medical writing, clinical research, or related functions.
• Experience supporting major regulatory filings, including NDA/BLA/MAA and IND submissions.
• Proven ability to lead complex projects and manage competing priorities.
• Strong communication skills with the ability to influence and collaborate across diverse teams.
• Broad scientific understanding across therapeutic areas; neuroscience experience preferred.
• Experience with resource planning, vendor management, and adoption of new tools and technologies.
• Hybrid work environment requiring onsite presence three days per week.