Director - Rapid Filing Team - Medical Writing

4 days ago

Apply Now

Receive Emails with Similar Jobs

Immunovant

WebsiteLinkedInAll Job Openings

Biotechnology Research

51 - 200

Description

• Organizational Overview: Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. • The Role: 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, and facilitating incoming Health Agency inquiries and 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

Benefits

• Unlimited paid time off • Parental leave • Medical insurance • Dental insurance • Vision insurance • 401k