[Hiring] Director, Medical Writing @Inctye

Role Description

The Director, Medical Writing is responsible for the medical writing activity within a portfolio of programs. This role ensures oversight of the development of clinical documents (e.g., Investigators' Brochures [IBs], Clinical Study Reports [CSRs], and marketing authorization submission documents) that accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements.

• Writes or provides direction and leadership to other writers to ensure timely delivery of high-quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation.
• Partners with the Head of Medical Writing to ensure deliverables are resourced and any issues are escalated.
• Keeps abreast of the clinical development of each compound within the assigned programs and has a functional understanding of global regulatory document standards.
• May have direct people management responsibilities and reports to a Director of Medical Writing or above.
• If a people manager, is a member of the Medical Writing Leadership Team contributing to the strategic direction of the department.

Qualifications

• Bachelor's degree required; advanced degree in a relevant scientific/clinical/regulatory field preferred.
• More than 10 years of medical writing experience in the biopharmaceutical/CRO industry required.
• Demonstrated ability to understand and interpret clinical and scientific data.
• Excellent project management skills, including in-depth understanding of clinical timelines and interdependencies among groups.
• Strong verbal, written, and interpersonal communication skills.
• Proficient understanding of global regulatory requirements; knowledge of therapeutic areas in all phases of clinical development desired.
• Demonstrated ability to independently lead the clinical portions of a marketing authorization submission.
• Proficient in MS Word and working knowledge of electronic document management systems.
• Ability to interact effectively with team members/leaders and senior leaders at Incyte.
• If a direct people manager, prior management experience preferred.

Requirements

• Ability to manage people and provide active support in all aspects of the job.

Benefits

• Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.