Associate Director, Medical Writing
Company Summary:
Immunovant, Inc. is a clinical-stage immunology company, dedicated to enabling normal lives for people with autoimmune diseases. As trailblazers in anti FcRn technology, we are developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.
Immunovant’s two investigational products, batoclimab and IMVT-1402, are novel, fully human, monoclonal antibodies that target FcRn and may reduce harmful immunoglobulin G (IgG) autoantibodies, which are common causes of autoimmune diseases. Currently, we are focusing on treating patients with Myasthenia Gravis (MG), Thyroid Eye Disease (TED), Chronic inflammatory demyelinating polyneuropathy (CIDP), and Graves’ Disease (GD).
Please see https://www.immunovant.com for more information
Associate Director, Principal Medical Writer Position Summary:
- 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.,).
- Contribute to strategy from a medical writing perspective.
- Assure documents are in accordance with the International Council for Harmonisation (ICH) and other regulatory guidelines.
- Represent medical writing at cross-functional meetings (e.g., kick-off meetings [KOMs], comment resolution meetings, strategy discussions, etc.,) and provide information regarding requirements for medical writing deliverables.
- Review protocols; amendments; statistical analysis plans (SAPs); table shells; tables, listings, and figures (TLFs), regulatory responses, and other regulatory documents to ensure consistency across all documents.
- Raise any concerns regarding inconsistencies across documents or writers with the IMVT Director or Medical Writing to resolve and ensure consistency across both assets.
- Arrange and lead team review meetings over the course of project progression.
- Produce high-quality and timely documentation and provide input on data analysis, planning, and interpretation.
- Maintain strict timelines as project lead.
- Coordinate QC review of documents.
- Mentor junior writers that are within the team.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the experience, knowledge, skill, and/or ability required.
Education/Experience: The ideal candidate will offer:
- At minimum a bachelor’s degree or equivalent in medical-related field or life science Post-graduate degree preferred.
- Minimum of 5 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.
- Experience in interacting with cross functional study team members Knowledge, Skills, and Abilities:
- 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.
- 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.
- 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.
- Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.
- Ability to utilize a balanced approach to problems, using flexibility and persistence as appropriate.
- Read, write, and speak fluent English; excellent verbal and written communication skills.
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