Associate Director – Medical Writing
Locations: Mississauga, ON (Canada); Cambridge, Cambridgeshire & London (UK); Carlsbad, Palo Alto & Philadelphia (USA) – Remote/Home-Based Options Available
Category: Research & Development
Experience Required: Minimum 8 years in medical writing; advanced degree holders: 5+ years preferred
About Jazz Pharmaceuticals
Jazz Pharmaceuticals is a global biopharma leader dedicated to transforming the lives of patients and families affected by serious diseases. With a diverse portfolio spanning sleep disorders, epilepsy, and oncology, Jazz combines patient-focused innovation with science-driven research to deliver life-changing therapeutics worldwide. Headquartered in Dublin, Ireland, Jazz operates across multiple countries, maintaining R&D laboratories, manufacturing facilities, and a strong global workforce. Learn more at www.jazzpharmaceuticals.com.
Role Overview
The Associate Director, Medical Writing will provide strategic leadership in medical writing deliverables across clinical programs, ensuring scientific accuracy, clarity, and regulatory compliance. This role involves collaboration with cross-functional teams to author regulatory documents, including protocols, clinical study reports, briefing books, submission dossiers, and investigator brochures. The incumbent may oversee contract or junior writers, ensuring consistent messaging and alignment with program objectives across global submissions.
Key Responsibilities
Lead the preparation of high-quality medical writing deliverables aligned with clinical and regulatory strategies.
Collaborate with cross-functional teams to ensure consistent communication of clinical data across study documents.
Analyze clinical study documents for clarity, accuracy, and compliance with regulatory requirements.
Participate in global regulatory submissions, ensuring alignment with ICH, CTD, and GCP guidelines.
Provide oversight of contract medical writers and coordinate project timelines and deliverables.
Contribute to best practices, SOPs, and process improvements in medical writing and disclosure management.
Review and ensure scientific accuracy, clarity, and compliance of all documents for health authority submissions.
Mentor and support team members in medical writing practices and program strategy alignment.
Required Qualifications
BA/BS in Life Sciences or related field with 8+ years of medical writing experience in pharmaceutical/biopharma industry; or advanced degree (MS, PharmD, PhD) with 5+ years of experience.
Proven experience in authoring regulatory documents across clinical development phases.
Strong understanding of clinical development processes, preclinical/nonclinical requirements, and global submission standards.
Expertise in ICH, CTD, and GCP guidelines, and familiarity with ICMJE, AMA, and GPP publication standards.
Exceptional English writing and editing skills with the ability to synthesize complex scientific information.
Experience in team leadership, mentoring, and managing multiple projects.
Proficient in MS Office and scientific document authoring tools.
Strong communication, strategic thinking, and cross-cultural collaboration skills.
Why Join Jazz Pharmaceuticals
Competitive compensation packages with base pay ranging from $154,400 – $231,600 USD (US-based candidates), plus discretionary bonuses and long-term equity incentives.
Comprehensive benefits programs, including medical, dental, vision, 401(k), and flexible vacation options.
Opportunity to work on global, high-impact clinical programs with a patient-centric and innovative biopharma company.
Inclusive and diverse workplace culture, emphasizing collaboration, professional growth, and global impact.
Jazz Pharmaceuticals is an Equal Opportunity Employer. All qualified candidates will receive consideration without regard to race, gender, religion, national origin, disability, veteran status, or other protected categories.
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