Associate Director Principal Medical Writer

Role Summary

Associate Director-Principal Medical Writer. Location: USA, Remote. Proximity to Cambridge/Boston, MA or Morristown, NJ is highly desirable for attending occasional team meetings.

Responsibilities

• Produce and/or coordinate timely English-language regulatory documentation for planning, initiation, performance, and reporting of clinical studies and for marketing approvals worldwide, in close cooperation with the Clinical Trial Team and Project Team.
• Provide dedicated scientific authoring to ensure clinical opinions are presented accurately and concisely.
• Coordinate with external services (e.g., CROs, subsidiaries, co-development partners) and internal support staff for tables, illustrations, and appendices.
• Mentor/train junior colleagues, manage Clinical Documentation teams, maintain contact with external departments, and coordinate external contractors.
• Represent Clinical Documentation in transversal initiatives to improve processes; lead projects to develop innovative solutions and technologies (e.g., content reuse, AI) to increase efficiency and reduce cost.
• Contribute to training preparation and delivery and support the medical writing teams.

Qualifications

• Minimum 6 years of experience as a Medical Writer, or equivalent.
• Ability to clearly, accurately, and concisely prepare all types of clinical documentation, including major submissions and/or complex documents in English.
• Excellent interpersonal and leadership skills.
• Ability to work autonomously and collaboratively within transversal, multicultural, multilingual, geographically dispersed teams.
• Deadline-oriented with a sense of urgency, accuracy, and meticulous attention to detail.
• Strong technical skills in electronic document management and word processing; proficient with Microsoft Word.
• Interest in emerging digital technologies, including content reuse and AI-assisted document authoring solutions.
• Native English speaker or proven excellent spoken and written English.
• Strong work ethic, professionalism, organizational ability, and follow-up skills.
• Advanced degree (Master or Ph.D.) in life sciences, PharmD, or medically qualified; more than 6 years of relevant medical writing experience or equivalent qualifications; experience as Lead Project Medical Writer on multiple clinical documents; solid understanding of clinical development, study performance/methodology, statistics, and regulatory environment; knowledge of targeted therapeutic areas is strongly desirable.

Skills

• Medical writing expertise across regulatory documents and clinical studies.
• Leadership and mentorship capabilities.
• Strategic thinking for regulatory documentation and process improvement.
• Proficiency with digital technologies and AI in document authoring.

Education

• Advanced scientific degree (Master or Ph.D.) in life sciences, PharmD, or medically qualified.

Additional Requirements

• None beyond qualifications listed.