Director, Specialty Documents - Medical Writing

Organizational Overview:

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

The Role:

Reporting to the Senior Director, Medical Writing Operations, this position is responsible for managing Medical Writing activities and deliverables for the authorship and support of safety-related documents, informed consent forms (ICFs), and various other submission documents, as well as Standard Operating Procedures (SOPs)/business processes across the Medical Writing/Regulatory Department. This role is also responsible for management of clinical trial registries.

Key Responsibilities: 

• Support of key documents, including but not limited to: Master Informed Consent forms, Investigator Brochures, safety documents (Health and Disability Ethics Committee [HDEC] Summaries, Development Safety Update Reports [DSURs], etc.)
• Standard Operating Procedures/Work Instructions
• Management and facilitation of clinical trial registries (e.g. Clinical Trial.gov, country specific registries)

Requirements:

• S./B.A. degree required, advanced degree highly desirable
• Minimum of 10 years of relevant Medical Writing experience in the pharmaceutical industry
• Preferred experience in clinical trial experience/clinical trial operations (3 years)
• An understanding of the drug development process
• 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; demonstrates the ability to interpret and apply these guidelines to document writing
• Ability to identify, provide, and manage Medical Writing resources for authorship and contributions to documents
• Expertise in authoring and editing safety-related documents and ICFs
• Comfortable and familiar with document authoring and formatting tools in conformity with style guides, templates, regulations, and internal standards
• Expert in data sourcing, verification, and internal consistency to ensure content accuracy across entire documents
• Familiar with authoring, editing, and reviewing SOPs in coordination with other team members
• Thorough knowledge of and proficiency with Clinical Trials.gov
• Excellent verbal and written communication skills with respect to different study team members
• Ability to resolve and/or escalate complex issues if appropriate
• Excellent interpersonal relationship skills; establishes and maintains professional and productive working rapport with team members
• Ability to interact with cross-functional study team members to access knowledge, skills and abilities
• Ability to contribute to determining realistic timelines and monitoring document progress to deliver within agreed company milestones
• Must possess excellent project management skills and attention to detail
• Must be able to read, write and speak fluent English

Work Environment:

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

Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $210,000 - $225,000.