Associate Director, Medical Writing (Regulatory)

Role Summary

The Associate Director, Medical Writing (Regulatory) will provide strategic and operational medical writing expertise to prepare high-quality clinical regulatory documents for Health Authority submissions. This position will collaborate across the organization to implement and maintain a standardized document development process for regulatory documents. This is a hybrid role typically requiring on-site presence at least 3 days per week.

Responsibilities

• Develop and execute strategies for organizing and preparing documents for regulatory health authority submissions
• Plan, prepare, write, edit, format, and finalize regulatory documents including IND, CTA/IMPD, NDA, MAA, clinical and non-clinical summaries, updates to regulatory submissions, meeting requests, briefing books, annual reports/development safety update reports (DSURs)
• Oversee document preparation activities and track progress against targets; produce timely and accurate status update reports
• Provide oversight of document quality and consistency for ease of review across multiple documents assembled in a regulatory dossier or briefing package
• Lead document review and comment resolution processes with cross-functional teams
• Leverage scientific expertise to write, review, and edit science-based documents such as those included in IND/NDA sections, meeting requests, briefing books and annual reports
• Coordinate the review and approval of documents
• Develop templates, style guidelines, and SOPs for regulatory documentation
• Ensure final documents adhere to standard operating procedures (SOP), good clinical practice (GCP), and International Council on Harmonization (ICH) requirements

Qualifications

• JD/Paralegal degree with scientific background or advanced scientific degree (MS, PhD or PharmD)
• Regulatory medical writing experience in the pharmaceutical industry/CRO environment or equivalent experience writing technical materials for submission to regulatory authorities, legal entities and/or other audiences
• Able to compile, analyze, and present data clearly, concisely, and effectively
• Experience participating in submissions to the US FDA (IND, NDA) and EMA (MAA)
• Strong understanding of drug development and regulations (US, EU and ICH)
• Broad knowledge of relevant regulatory guidelines (e.g., FDA, EMA) and compliance requirements
• Proficiency with Electronic Common Technical Document (eCTD) templates
• Strong verbal and written communication skills to effectively collaborate with cross-functional teams and address regulatory queries

Education

• JD/Paralegal degree with scientific background or advanced scientific degree (MS, PhD or PharmD)

Additional Requirements

• Applicable to travel/onsite requirements if relevant to the role: hybrid role typically requiring on-site presence at least 3 days per week