Director, Medical Writing

April 9

Intel Corporation

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Intel’s mission is to shape the future of technology to help create a better future for the entire world$1. .$1

semiconductor design and manufacturing • artificial intelligence • autonomous driving • non-volatile memory solutions

10,000+

Description

• Reporting to: Head of Medical Writing Operations & Regulatory Business Operations • Organizational Overview: Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. • The Role: Responsible for partnering cross-functionally to deliver high quality regulatory and clinical documents. • Coordinate and author clinical and regulatory documents to ensure integration of scientific and medical input from development team members. • Lead submission-level documents at the project manager level and handle all components of writing clinical regulatory documents (e.g., Protocols, clinical study reports [CSRs], investigator brochures [IBs], etc.,). • Evaluate the consistency of style guide, scientific technical aspects and consistency of messaging across therapeutic area documents • Contribute to strategy from a medical writing perspective. • Assure documents are in accordance with the International Council for Harmonisation (ICH) and other regulatory guidelines. • Direct, train, and assist other medical writers in the writing and editing of clinical and regulatory documents.

Requirements

• S./B.A. degree required, advanced degree highly desirable. • Minimum of 12 years of relevant medical writing experience in the pharmaceutical industry, especially writing in one or more of the ophthalmology or rare diseases therapeutic areas. • An understanding of the drug development process. • Strong leadership skills. • Mentorship skills to train early career writers • Experience managing direct and indirect reports, including medical writing contractors. o Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing. o Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details. o Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately. o Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members. o Ability to utilize a balanced approach to problems, using flexibility and persistence as appropriate. o Read, write, and speak fluent English; excellent verbal and written communication skills.

Benefits

• Remote-based • Dynamic, interactive, fast-paced, and entrepreneurial environment • Domestic or international travel are required (10-20%)