Associate Director, Medical & Regulatory Writing

• Serve as medical writer and subject matter expert preparing clinical regulatory documents through all phases of clinical research
• Execute the clinical trial transparency and disclosure book of work and provide vendor oversight
• Collaborate with regulatory affairs, clinical development, clinical operations, biostatistics, pharmacology, translational research, manufacturing, and other cross‑functional teams
• Manage document review processes and resolve conflicting or ambiguous comments
• Establish and monitor timelines for document deliverables
• Prepare documents according to agreed timelines and regulatory standards, including ICH-E3 and company SOPs
• Develop, improve, and maintain medical writing work‑practice documents, SOPs, and templates
• Represent medical writing in cross‑functional meetings
• Lead global clinical trial transparency and disclosure policy development
• Lead preparation and maintenance of CCI and PPD rules across programs
• Apply lean writing practices to minimize CCI and PPD
• Analyze, validate, and prioritize complex information from diverse sources
• Manage, track, and present assigned work; compile and report performance metrics
• Manage plain‑language synopses, summaries, and clinical‑document redactions under FDA, EMA, EU Clinical Trial Regulation, Health Canada PRCI, and other global requirements
• Educate the company on transparency/disclosure regulations, industry trends, layperson summaries, and clinical study diversity planning
• Coordinate cross‑functional teams and liaise between vendors and internal teams for documents and postings
• Collaborate on diversity action plans in accordance with FDA guidance
• Coordinate multiple projects and programs aligned with corporate timelines and strategic plans
• Maintain current knowledge of medical‑writing industry trends and best practices
• Perform other duties as assigned

Requirements

• Masters or advanced degree in scientific, medical, or clinical discipline (e.g., PhD, PharmD, or equivalent) is required; PhD preferred
• Minimum of 8–10 years of relevant industry experience as a regulatory/scientific writer in a pharmaceutical, biotech, or CRO environment
• CTD experience; vendor oversight a plus
• Experience authoring clinical study reports, protocols, protocol amendments, and Investigator’s Brochures
• Experience authoring briefing books and Module 2 clinical summaries is a plus
• Solid understanding of drug development, clinical research, data analysis, CTD, ICH guidelines, GxP, regulatory interactions, and relevant regulations and guidance
• Ability to manage competing priorities in a fast‑paced environment
• Excellent problem‑solving, organizational, analytical, and critical‑thinking skills
• Excellent written and verbal communication skills
• Strong attention to detail regarding consistency, grammar, syntax, and formatting
• Familiarity with eCTD‑compliant templates and formatting tools such as ISI Writer, Liquent Smart Desk, or Acumen Stylus is a plus
• Proficient in MS Office Suite, EndNote, and Adobe Acrobat
• Experience with an EDMS such as Documentum, Core Dossier, or Veeva
• Ability to travel up to approximately 10% of the time
• Ability to work collaboratively and facilitate cross‑functional coordination
• Must have proficiency in Veeva or equivalent software for document creation, review, and QC

Core Competencies

Demonstrates expertise in medical writing and regulatory documentation, with a strong focus on clinical trial transparency and compliance with ICH guidelines and global regulations. Proficient in managing cross‑functional collaboration and document review processes while maintaining high standards of quality and detail.

Highest‑signal resume keywords

• Medical Writing Expertise
• Regulatory Documentation
• Clinical Trial Transparency
• CTD Experience
• Vendor Oversight

ATS Optimization Keywords

Hard Skills

• Clinical Study Report Authoring
• Protocol Authoring
• Data Analysis
• GxP Compliance
• ICH Guidelines
• Regulatory Interactions
• Document Review Management
• Lean Writing Practices
• Performance Metrics Reporting
• Plain‑Language Summaries

Soft Skills

• Problem‑Solving
• Organizational Skills
• Analytical Skills
• Critical Thinking
• Attention to Detail

Certifications & Qualifications

• Masters or Advanced Degree in Scientific Discipline
• PhD Preferred

Industry Keywords

• Pharmaceutical
• Biotech
• CRO
• FDA Regulations
• EMA Regulations
• EU Clinical Trial Regulation
• Health Canada PRCI
• Clinical Research
• Diversity Action Plans
• SOP Development

Tools & Technologies

• MS Office Suite
• EndNote
• Adobe Acrobat
• ECTD Templates
• ISI Writer
• Liquent Smart Desk
• Acumen Stylus
• Documentum
• Core Dossier
• Veeva