[Hiring] Associate Director, Principal Medical Writer II @Incyte Corporation

Role Description

The Associate Director, Principal Medical Writer II is responsible for the development of clinical documents for submissions to regulatory authorities globally. Provides strategic direction to cross-functional project teams with minimal oversight to ensure that clinical documents (e.g., Investigators' Brochures [IBs], Clinical Study Reports [CSRs], and marketing authorization submission documents) 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 the timely delivery of high-quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation.
• Oversees the medical writing activities of multiple compounds and serves as lead writer for individual summary documents.
• Has a broad understanding of clinical research processes and global regulatory document standards.
• Mentors less experienced writers.
• Reports to a Director of Medical Writing or above.

Qualifications

• Bachelor's degree or equivalent experience required.
• Advanced degree in a relevant scientific/clinical/regulatory field or equivalent experience preferred.
• Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.
• Proficient in MS Word.
• Experience with an electronic document management system and templates is required.
• Proficient understanding and knowledge of global regulatory requirements needed and knowledge of therapeutic areas in all phases of clinical development preferred.
• Excellent project management skills including in-depth understanding of clinical timelines (study and submission level) and working knowledge of roles of other functional areas and the interdependencies among groups.
• Demonstrated ability to understand and interpret clinical and scientific data with minimal oversight; ability to define data presentation to meet key messages developed by the clinical team.
• Ability to interact effectively with colleagues and leaders at all levels, proactively facilitating effective information exchange and communication, including problem solving and issue resolution.
• Demonstrated ability to independently lead the development, review, and approval of clinical documents and the ability to identify any new or unique document types that may require a different approach.

Company Description

A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.