Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compound, batoclimab, is a novel, fully human, monoclonal antibody targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.
The Senior Director, Medical Writing prepares and reviews clinical/regulatory documents to support all phases of drug development by leading the writing activities of an interdisciplinary team to develop documents that are strategic, high quality, and comply with internal and external standards. This role is responsible for the complete preparation, including but not limited to, the writing, reviewing, editing, and finalization of protocols and protocol amendments, Investigator’s Brochures (IBs) and IB updates, clinical study reports (CSRs), Summary Modules for Regulatory Submissions, regulatory agency briefing documents, and regulatory agency responses.
The Senior Director, Medical Writing will lead the writing activities for all clinical and regulatory documents for the program, which include leading and managing the writing process, managing and driving timelines for multiple parallel documents, and ensuring documents are quality-checked. This individual will develop strong collaborative working relationships with cross-functional team members. As a content expert, this position has a significant understanding of regulatory requirements and ICH guidelines (including E3 and E6), and knowledge of electronic document formats and document management systems. The Senior Director, Medical Writing will collaborate with the Head of Medical Communications to align core concepts and strategic messaging between clinical/regulatory documents and medical communications such as publications/posters/abstracts.
- Authoring, facilitating review cycles, finalization of submission-ready documents compliant with regulations and aligned with core messages
- Manage timelines and cross-functional relationships
- Interpret complex data for communication
- Minimum 5 years of medical writing experience in pharma/biotech with a Master’s of Science degree, PharmD, PhD, or MD preferred;
- Minimum 7 years of medical writing experience in pharma/biotech with a Bachelor's degree in Life Sciences.
- Experience authoring successful global clinical and regulatory documents, such as clinical protocols and amendments, clinical study reports, investigator’s brochures, regulatory agency meeting briefing documents, regulatory agency responses, NDA/BLA/MAA summary sections, white papers
- Strong science background that enables the ability to independently interpret and present scientific and clinical data, and to understand statistical methods and analysis plans
- Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submissions.
- Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs and electronic submission-ready documents).
- Proven ability to lead cross-functional teams through the authoring, reviewing, and finalization process and meet timelines
- Strong communication and interpersonal skills and the ability to negotiate and influence in a cross-functional environment to achieve results
- Excellent team player who can effectively collaborate with varied opinions and personalities
- Able to work well both independently and as part of a team
- Excellent organizational and project management skills, including managing simultaneous projects in a fast-paced environment
- Familiar with style rules from the American Association Manual of Style and stays current with changes and expectations in templates and document formats
- Excellent understanding of Microsoft Word and Powerpoint, document management systems, and electronic review tools
- Immunology or biologics experience preferred
- Experience with neurology, rare diseases preferred
- Experience with orphan drug designations, other regulatory designations, PSP/PIPs a plus
- Commitment to company values and culture
- Proven ability to adapt to change and uncertainty as projects evolve
- Strong oral and written communicator
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
- Ability to multi-task and adjust priorities quickly while working under tight deadlines.
- Skilled in developing collaborative internal and external relationships.
- Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
- Immunovant’s headquarters is located in New York City. The position is flexible for remote work
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- May need to travel to NYC office or Durham office as needed