Associate Director-Principal Medical Writer

Role Summary

Associate Director-Principal Medical Writer responsible for timely preparation and coordination of English-language regulatory documents for clinical studies and regulatory submissions, providing scientific authoring expertise, and mentoring/leading Clinical Documentation teams.

Responsibilities

• Produce and update clinical documents in a timely manner for study start, conduct and completion, as well as regulatory submissions to gain regulatory approval of therapeutic indications.
• Coordinate medical writing activities in study teams, including external services; share information among medical writers and contribute to improving standards of clinical documentation.
• Review clinical development plans to ensure adequate planning of medical writing activities; advise on regulatory requirements and efficiency strategies.
• Prepare or coordinate preparation of clinical modules for registration dossiers (EU/US) ensuring consistency across documents.
• Prepare or coordinate responses regarding drug submission dossiers to Health Authorities.
• Review and edit work of contract writers to ensure quality.
• Build and sustain rapport with clinical personnel and establish cross-functional relationships with other departments, especially Regulatory Operations.
• Maintain awareness of current clinical documentation requirements for target regulatory agencies; notify management of changes and their impact on systems/processes.
• Represent Clinical Documentation as Subject Matter Expert on transversal initiatives; lead projects implementing new processes or IT solutions to improve efficiency and reduce costs.
• Act as change agent for the medical writing teams; share experience and train other medical writers.
• In collaboration with ITS, lead transversal project teams implementing new technologies to accelerate document preparation and provide cost savings.

Qualifications

• Minimum 6 years of experience as a Medical Writer, or equivalent.
• Ability to prepare all types of clinical documentation clearly, accurately, and concisely in English, including major submissions and complex documents.
• Excellent interpersonal and leadership skills; ability to work autonomously and collaboratively in a multicultural, multilingual, and geographically dispersed environment.
• Deadline-oriented with a sense of urgency, accuracy, and attention to detail.
• Technical proficiency with electronic document management and Microsoft Word; interest in emerging digital technologies including AI-assisted authoring.
• Native English or excellent spoken and written English; solid work ethic and organizational skills.

Education

• Advanced scientific degree (Master or Ph.D. in life sciences, PharmD, or medically qualified).
• 6+ years as a medical writer or equivalent; experience as Lead Project MW on multiple clinical documents.
• Strong understanding of clinical development, study performance/methodology, basic statistics, and regulatory environment.

Skills

• Clear, accurate, concise clinical documentation in English.
• Leadership and collaboration across cross-functional teams.
• Project management and coordination of external services.
• Regulatory documentation standards and strategic thinking for efficiency gains.
• Content reuse strategies and AI-enabled document authoring solutions.

Additional Requirements

• Knowledge of company-targeted therapeutic areas is desirable but not essential.