Full-Time Director, Global Medical Writing

This is an exciting leadership opportunity for a passionate and talented individual.

The Role: The Medical Writing team seeks an experienced, self-motivated Director, Medical Writing, knowledgeable about the current Medical Writing landscape.

Responsibilities Include:

1. Leading document strategy and development of complex clinical documents.
2. Mentoring junior medical writers.
3. Planning, implementing, and adhering to medical writing timelines.
4. Representing Medical Writing on cross-functional teams.
5. Participating in NDA/MAA/IND submission planning and preparation.
6. Leading/participating in significant workstreams.
7. Developing and participating in department training.
8. Performing reviews of medical writing deliverables.
9. Maintaining cutting-edge knowledge.
10. Representing Medical Writing in Inspection Readiness and GCP Audits.

Qualifications:

• PhD or equivalent + 8+ years experience, or Master's/Bachelor's + 12+ years experience.
• Extensive experience authoring regulatory and clinical documents.
• Strong experience across ICH regions.
• Excellent verbal and written communication skills.
• Knowledge of clinical trial disclosure.
• Proficiency with eCTD Starting Point templates, Smart Sheet, databases, presentation software (MS Office), Veeva Vault.
• Oncology, immunology, or neurology experience preferred.

What is the last date for applying to the job?

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