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Director, Rapid Filing Team - Medical Writing

Remote

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 in support of the Rapid Filing Team (RFT) writing needs for documents such as protocols, substantial modifications, and informed consent forms (ICFs).

Key Responsibilities: 

  • Managing Medical Writing document deliverables
  • Supporting Rapid Filing Team (RFT) document deliverables and management
  • Responsible for the Rapid Filing Team writing needs for documents in Clinical Trial Applications (CTA) such as protocols, substantial amendments, redactions and ICFs.
  • Facilitate with team the incoming Health Agency inquiries and responses from the Sponsor.  Application, knowledge and ability to articulate the  study details and the disease state to support these queries are expected.
  • Expected to work with Director, Medical Writing indication leads on Request for Information (RFI) responses

Requirements:

  • S./B.A. degree required, advanced degree highly desirable
  • Minimum of 8 years of relevant Medical Writing experience in the pharmaceutical industry
  • 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
  • Excellent knowledge of Clinical Trials Information System (CTIS) and Clinical Trials.gov
  • Demonstrates an understanding of CTR in the EU and ex-EU requirements
  • Provides Medical Writing support and partners with Subject Matter Experts for the content of responses to the RFIs and to ensure the timely submission and review of CTAs and substantial protocol amendments
  • Collaborates with study teams to drive, facilitate and achieve Clinical Trials Regulation (CTR) transitions, substantial modifications and amendments, and scoped new CTAs
  • Coordinates with the RFT to provide Medical Writing support to perform redactions of protocols and ICFs consistent with new directives of Clinical Trials Information System (CTIS)
  • Excellent verbal and written communication skills with respect to different study team members to expedite CTA submissions in a time-critical but realistic manner and escalate complex issues appropriately
  • Excellent interpersonal relationship skills; establishes and maintains professional and productive working rapport with team members
  • Ability to interact with cross-functional study team members’ knowledge, skills and abilities
  • Ability to monitor progress against milestones to deliver within agreed internal and regulatory timelines
  • 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.

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