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Director, Medical Writing
Reporting to: Head of Medical Writing Operations & Regulatory Business Operations
Location: Remote
Organizational Overview:
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As 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 Head of Medical Writing Operations & Regulatory Business Operations, this position is responsible for partnering cross-functionally to deliver high quality regulatory and clinical documents.
Key Responsibilities:
Requirements
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.
Work Environment:
Full Time
$248k-317k (estimate)
04/10/2024
06/30/2024
imvt.net
<25
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