Senior Director, Medical Writing Operations

Organizational Overview:

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 compounds, Batoclimab (IMVT-1401) and IMVT-1402, are both novel, fully human, monoclonal antibodies targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, both are designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.

The Role:

The Senior Director, Medical Writing Operations, coordinates and facilitates Medical Writing operational needs to support all phases of producing high quality, specialty submission documentation that comply with internal and external standards. This position will need to understand regulatory requirements and ICH guidelines (including E3 and E6) and knowledge of electronic document formats and document management systems.  This role will manage the specialty document development writing process, managing and driving timelines for multiple parallel documents and ensuring all specialty documents are quality-checked.  These specialty documents include, but are not limited to, Informed Consent Forms (ICFs), Pharmacy Manuals, Instructions for Use and nonclinical sections.  This role will also:

• Manage key submission documents (Master ICFs, etc.) via effective supervisory responsibilities of Document Specialist role(s) in Medical Writing Operations group;
• Manage clinical trial registry activities ensuring compliancy to guidance and to defined process;
• Collaborate and partner with the Rapid Filing Team (exUS submission activities on clinical trial applications), which includes, but is not limited to, CTIS activities (e.g., review of CTIS forms), redactions in all documents, authoring of exUS Health Authority Requests for Information, protocols, ICFs;
• Manage the Medical Writing/Regulatory Department Standard Operating Procedures (SOPs) and processes; and
• Facilitation of any specific clinical operations, clinical development and medical writing process needs.

Key Duties and Responsibilities: 

• Authoring, facilitating review cycles, finalization of submission-ready specialty documents compliant with regulations and aligned with core messages.
• Ensure strong partnership and collaboration with the Senior Director of Medical Writing.
• Confirm that all specialty documents are in compliance with regulations, GXP standards and guidelines.
• Develop and grow the Medical Writing Department as needed to ensure quality output at all times, while prioritizing/delivering the pipeline.
• Contribute to cross-functional working groups to facilitate efficient development and finalization of specialty documents for submissions.
• Establish and manage timelines and cross-functional relationships.
• Assignment of writers, internal and external.
• Management and communication of budgets for operational writing resources; this includes management of vendor agreements, budgets and invoices for Operational Medical Writing.
• Management of Medical Writing contractors and full-time employee onboarding.
• Responsible for staff agendas, off-site meetings and functional administrative and logistical issues.
• Develop and manage department SOPs, working instructions, manuals and templates, as needed.

Requirements:

• BS./B.A. degree.
• Minimum of 10 years of medical writing experience.
• Minimum 4 years of business experience managing operations in the Medical Writing function.
• A very detailed oriented mindset to review and conduct detailed quality control metrics on a document.
• Ability to write and proofread documents and provide input to generate quality documents at all times.
• Proven ability to lead cross-functional teams through the authoring, reviewing and finalization process and meet timelines.
• Required experience in clinical operations for 2-4 years (e.g., clinical trial implementation, clinical operations, registries experience).
• Basic understanding of EU CTR and ROW submission document requirements.
• Excellent team player who can effectively collaborate with varied opinions and personalities cross-functionally.
• Able to work well both independently and as part of a team.
• Excellent organizational skills, including managing simultaneous projects in a fast-paced environment.
• Commitment to company values and culture.
• Proven ability to adapt to change and uncertainty as projects evolve/shift and to multi-task and adjust priorities quickly while working under tight deadlines.
• Strong oral and written communicator.
• Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
• Skilled in developing collaborative internal and external relationships.
• Strong PC experience, demonstrating proficiency in MS Office (Outlook, Word, Excel, PowerPoint), and electronic review tools (Veeva RIM).

Communication:

• Establish strong communication and interpersonal skills and the ability to negotiate and influence in a cross-functional environment to achieve results.
• Manage, develop, mentor and assist in retention of internal and external Operational Medical Writing staff.

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 $255,000.00 - $265,000.00.