Associate Director, Medical & Regulatory Writing

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Act as a medical writer and subject matter expert, producing clinical regulatory documents throughout all stages of clinical research.

• Implement the clinical trial transparency and disclosure initiatives while overseeing vendor activities.

• Collaborate with teams across regulatory affairs, clinical development, clinical operations, biostatistics, pharmacology, translational research, manufacturing, and other cross-functional departments.

• Oversee document review processes and address conflicting or unclear feedback.

• Set and track timelines for document deliverables.

• Create documents in compliance with established timelines and regulatory standards, including ICH-E3 and company SOPs.

• Design, enhance, and maintain medical writing work-practice documents, SOPs, and templates.

• Represent the medical writing team in cross-functional meetings.

• Spearhead the development of global clinical trial transparency and disclosure policies.

• Lead the preparation and upkeep of CCI and PPD rules across various programs.

• Utilize lean writing techniques to reduce CCI and PPD.

• Assess, validate, and prioritize intricate information from various sources.

• Manage, monitor, and report on assigned tasks; compile and present performance metrics.

• Handle plain-language summaries, synopses, and clinical-document redactions in accordance with FDA, EMA, EU Clinical Trial Regulation, Health Canada PRCI, and other global standards.

• Educate the organization on transparency and disclosure regulations, industry trends, layperson summaries, and planning for clinical study diversity.

• Facilitate communication between cross-functional teams and vendors regarding documents and postings.

• Collaborate on diversity action initiatives in line with FDA guidance.

• Manage multiple projects and programs that align with corporate timelines and strategic goals.

• Stay informed about current trends and best practices in the medical writing industry.

• Perform additional duties as required.

⛳️ Requirements

• A Master's or advanced degree in a scientific, medical, or clinical field (e.g., PhD, PharmD, or equivalent) is essential; a PhD is preferred.

• At least 8–10 years of pertinent industry experience as a regulatory/scientific writer in a pharmaceutical, biotech, or CRO setting.

• Experience with CTD; vendor oversight is advantageous.

• Proficient in authoring clinical study reports, protocols, protocol amendments, and Investigator’s Brochures.

• Experience with authoring briefing books and Module 2 clinical summaries is a plus.

• Strong grasp of drug development, clinical research, data analysis, CTD, ICH guidelines, GxP, regulatory interactions, and associated regulations and guidance.

• Ability to handle competing priorities in a dynamic environment.

• Exceptional problem-solving, organizational, analytical, and critical-thinking capabilities.

• Outstanding written and verbal communication skills.

• Keen 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.

• Willingness to travel up to approximately 10% of the time.

• Ability to work collaboratively and facilitate coordination across functions.

• Must be proficient in Veeva or similar software for document creation, review, and quality control.

🏝️ Benefits

• Comprehensive benefits package featuring a variety of plans with a significant employer match.

• Annual target bonus.

• 401K with employer contributions.

• Generous stock options.

• Employee Stock Purchase Plan (ESPP).

• 20 days of paid time off (PTO) to start.

• 18 holidays, including Summer and Winter Break.

• Paid maternity/paternity leave.

• Opportunities for career advancement and development.

• In-office catered lunches.

• Home office setup support.

• Lifestyle spending stipend.

• Commuter stipend for the Boston Office.

• Regular employee social events, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and more.