Associate Director, Medical Writing Science

Job Description

Job Description

Position: Associate Director, Medical Writing Science
Location: Hybrid — 3 days per week in the Boston office; 2 days remote
Duration: 2+ month contract with possibility for extension or conversion

General Summary
The Associate Director, Medical Writing Science manages the overall operations of a team or major project and implements this through effective leadership. This role provides guidance and leadership for document development supporting regulatory filings and coordinates the clinical sections of complex regulatory submissions, including organization, content, and resource requirements.
The Associate Director applies advanced technical expertise to develop solutions to complex problems, fosters interdisciplinary understanding, and integrates Medical Writing Science activities with those of other departments. The role requires strong strategic thinking, cross-functional collaboration, scientific expertise, and the ability to lead teams and drive operational excellence.
Key Duties and Responsibilities

• Independently authors routine and complex clinical and regulatory documents.
• Provides strategic input into program-level plans and regulatory submission strategies.
• Demonstrates a deep understanding of how different functions contribute to the success of clinical development programs.
• Aligns, coordinates, and builds consistent information, data, and messaging across clinical programs.
• Provides leadership for Medical Writing Science activities and manages a team of medical writing professionals.
• Participates in developing and implementing departmental goals, strategies, and initiatives.
• Facilitates the implementation of new technologies, tools, and initiatives related to the preparation of clinical and regulatory documents.
• Proactively anticipates risks, solves complex problems, and develops and implements process improvements.
• Partners effectively with cross-functional stakeholders to ensure high-quality, timely, and consistent regulatory documentation.
• Supports resource planning and prioritization across projects and programs.
• Provides mentorship, coaching, and professional development opportunities for team members.

Knowledge and Skills

• Demonstrated ability to plan, manage, and optimize department resources, including staff and technology, to maximize and streamline organizational goals and objectives.
• Proven record of leadership, independence, and ability to solve non-routine, complex problems involving a broad range of issues.
• Strong ability to anticipate potential problems and develop contingency plans as needed.
• Broad understanding of scientific disciplines beyond one's primary area of expertise.
• Experience managing direct reports and supporting staff development.
• Demonstrated experience with marketing authorization applications and regulatory submissions.
• Strong knowledge of clinical development and regulatory requirements.
• Excellent written, verbal, organizational, and cross-functional communication skills.
• Ability to manage multiple priorities and deliver high-quality work within established timelines.

Education and Experience

• Bachelor's degree in a relevant scientific or related discipline.
• Ph.D. or equivalent advanced degree.
• Typically requires approximately 8 years of relevant professional experience and at least 2 years of supervisory or management experience, or an equivalent combination of education and experience.
• Experience in medical writing, regulatory writing, clinical development, or a related discipline.
• Experience supporting complex regulatory submissions and working within cross-functional development teams.