Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Associate Director, Medical Writing

5-8 years
USD 154,400 – 231,600
10 Dec. 18, 2025
Job Description
Job Type: Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Associate Director, Medical Writing | Remote / Home-Based (Global)

Req ID: R010768
Job Category: Research & Development / Medical Writing
Job Type: Full-Time
Locations: Mississauga, ON, CA; Cambridge, Cambridgeshire, UK; London, UK; Carlsbad, CA; Palo Alto, CA; Philadelphia, PA


About Jazz Pharmaceuticals

Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and often underserved medical conditions. Our portfolio spans neuroscience, oncology, sleep disorders, and epilepsy, combining scientific innovation with a patient-centric approach. With research and development laboratories, manufacturing facilities, and teams across multiple countries, Jazz is committed to advancing breakthrough therapies worldwide.

For more information, visit www.jazzpharmaceuticals.com.


Role Overview

The Associate Director, Medical Writing is a senior medical writing professional responsible for producing high-quality, strategically aligned regulatory documents across one or more clinical programs. This role involves collaboration with cross-functional teams to author protocols, clinical study reports, briefing documents, submission packages, and investigator brochures.

The position may include management of medical writers, oversight of contract writers, and participation in global regulatory submissions. The Associate Director ensures consistency in scientific messaging, mitigates risks related to medical writing processes, and contributes to best practices and SOP development.

This is a global, remote role with interaction across multiple regions and regulatory agencies.


Key Responsibilities

Strategic Medical Writing

  • Collaborate with cross-functional teams to ensure effective communication of clinical data.

  • Contribute to clinical development planning by ensuring early alignment of messaging and data presentation.

  • Analyze study-level documents to optimize clarity and regulatory impact.

  • Deliver high-quality regulatory writing consistent with global standards and departmental SOPs.

  • Participate in global submissions and contribute to regulatory interactions as required.

Team Leadership and Project Oversight

  • Mentor and provide guidance to medical writing teams.

  • Oversee contract medical writers to ensure timely and budget-compliant deliverables.

  • Coordinate multiple writing projects across programs while maintaining quality and consistency.

Communication and Collaboration

  • Serve as a strategic partner to R&D, regulatory, and commercial teams.

  • Facilitate alignment of content across documents to support company objectives.

  • Demonstrate multicultural sensitivity and the ability to collaborate in a global environment.

Compliance and Standards

  • Ensure adherence to ICH, GCP, CTD guidelines, and company SOPs.

  • Uphold best practices for clinical publications and external communications (ICMJE, AMA, GPP).

  • Critically evaluate complex scientific information to maintain scientific accuracy and integrity.


Required Qualifications

  • BA/BS with ≥8 years of pharmaceutical or clinical writing experience across therapeutic areas OR Advanced Degree (PharmD, PhD, MD, or equivalent) with ≥5 years of industry writing experience

  • Expertise in regulatory document authoring: protocols, clinical study reports, submission packages

  • Solid understanding of clinical development and global regulatory requirements

  • Exceptional written and verbal communication skills

  • Proficiency with MS Office (Word, Excel, PowerPoint) and medical writing tools

  • Ability to manage multiple projects and prioritize deliverables

  • Strong strategic thinking, problem-solving, and interpersonal skills


Preferred Qualifications

  • Experience leading complex medical writing projects and teams

  • Knowledge of early development and preclinical regulatory documents

  • Global submission experience across multiple regions

  • Ability to influence scientific content and align documents with regulatory strategy


Compensation and Benefits (US-Based Candidates)

  • Base Salary Range: USD 154,400 – 231,600 per year

  • Eligibility for discretionary annual bonus or incentive compensation

  • Long-term equity incentives

  • Comprehensive medical, dental, and vision coverage

  • 401(k) retirement plan and flexible paid vacation

Jazz Pharmaceuticals ensures competitive, equitable compensation based on experience, qualifications, and internal equity considerations.

For full benefits information: Jazz Pharmaceuticals Benefits


Equal Opportunity Statement

Jazz Pharmaceuticals is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration regardless of race, color, religion, sex, national origin, disability status, veteran status, or any characteristic protected by law.