Associate Director, Regulatory and Medical Writer

Summary

The Associate Director, Medical Writing is responsible for leading the planning, development, and delivery of complex clinical and regulatory documents in support of global regulatory submissions and development programs. This role provides strategic leadership within the Regulatory and Medical Writing function, serving as a key partner to Clinical Development, Biostatistics, and other cross-functional teams to ensure high-quality, scientifically rigorous, and compliant regulatory documentation.

Responsibilities

• Working with the Executive Director, Regulatory and Medical Writing, lead the development, authoring, and delivery of complex regulatory documents such as clinical study reports and marketing application summary documents (Module 2), and lead and/or contribute to Investigator’s Brochures, clinical study protocols, and briefing documents.
• Serve as Regulatory Medical Writing lead on cross-functional program teams, partnering with Clinical Development, Regulatory Affairs, Biostatistics, Safety, and other stakeholders.
• Provide strategic input into regulatory document planning and submission strategies to support global regulatory filings.
• Function as subject matter expert within the department for assigned therapeutic/product areas.
• Responsible for planning (in collaboration with Global Project Management) and leading cross-functional teams to meet timelines for deliverables.
• Lead complex scientific key messaging/storyboarding cross-functional meetings, ensuring the messages are clear and consistent within and across documents.
• Understand, assimilate, and interpret sources of information independently.
• Ensure compliance with appropriate conventions, proper grammar usage, and correct format requirements, as needed (e.g., formatting, hyperlinking).
• Manage review cycles for documents; schedule and lead data interpretation meetings, comment resolution meetings, and other document-related meetings.
• Perform quality control (QC) reviews as necessary.
• Interact with Quality Assurance (QA) as document lead to resolve audit findings for specific documents.
• Maintain expert knowledge of US and international regulations, requirements, and guidance associated with preparation of regulatory documentation.
• Support Global Regulatory Lead with preparing information/responses requested by regulatory agencies.
• Mentor and provide guidance to junior and senior medical writers, contributing to departmental best practices and writing standards.
• Other duties as assigned.

Requirements

• Bachelor’s degree required; advanced degree in a scientific, clinical, or regulatory field preferred.
• 12+ years of medical writing experience in the pharmaceutical industry, including marketing applications (e.g., Module 2.5, 2.7.3, 2.7.4). Rare disease experience a plus.
• Proven lead writer experience for key regulatory documents (e.g., CSRs, protocols, IBs, INDs, NDAs, briefing documents), strong expertise in safety sections preferred.
• Demonstrated experience leading medical writing activities for major regulatory submissions, including marketing applications.
• Significant experience as lead writer for Module 2 summary documents (e.g., 2.5, 2.7.1, 2.7.2, 2.7.3, and 2.7.4) and other key regulatory documents.
• Experience writing clinical study reports, Investigator Brochures, clinical protocols, IND/NDA sections, and regulatory briefing documents. In depth experience writing Safety sections of regulatory documents preferred.
• Experience writing requests for regulatory designations (e.g., Breakthrough Designation, Orphan Drug, Sakigake, PRIME, etc) a plus.
• Strong understanding of the drug development lifecycle and regulatory submission processes.
• Extensive knowledge of FDA, EMA, and ICH guidelines (especially ICH E3 and E6[R3]).
• Demonstrated ability to lead cross-functional teams and manage complex document development projects.
• Strong ability to interpret complex scientific and clinical data and translate it into clear regulatory narratives.
• Proficiency in American Medical Association (AMA) style guidelines.
• Advanced attention to detail with expertise in scientific editing, formatting, and document QC.
• Technical proficiency with Microsoft Office and Adobe Acrobat, and document management systems such as Veeva.
• Experience with StartingPoint templates preferred.
• Advanced written and verbal communication skills (including presentations), and project management skills, with the ability to clearly communicate complex scientific concepts across functional teams.
• In-depth experience using style guides, lexicons, and eCTD requirements.
• Demonstrated ability to mentor writers and contribute to a collaborative team environment.
• Energetic, self-motivated, and able to thrive in a dynamic, intense, and fast-paced environment.
• Advanced time-management skills. Ability to balance multiple projects simultaneously.