Senior Director, Medical Writing Portfolio Management
The Role:
The Senior Director, Medical Writing Portfolio Management, coordinates and facilitates Medical Writing portfolio 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 communication of deliverables and ongoing assessment of resources to support he various teams and molecules. The ability to communicate concisely, succinctly to all levels of the organization is needed. The document scope included in this roles entails protocols, investigational brochures, Informed Consent Forms (ICFs), Pharmacy Manuals, as well as briefing books and regulatory responses.
This role will also:
• Collaborate with Project Management to enable delivery and resourcing to support ongoing study team documents
• Manage key submission documents and issues as they arise to facilitate any concerns and or solutions needed to streamline the writing process
• Collaborate with global regulatory affairs to manage and partner on strategic regulatory documents
• Oversight of the Medical Writing/Regulatory Department Standard Operating Procedures (SOPs) and processes with a Lense of right sizing for biotech
• Integration into clinical operations to facilitate a seamless integrations of Protocol amendments, IB updates, and any ICFs updates
Key Duties and Responsibilities:
• Authoring, facilitating review cycles, finalization of submission-ready specialty documents compliant with regulations and aligned with core messages on both batoclimab and IMVT-1402.
• 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.
• Supervise, develop and manage the Medical Writing Department.
• Ensure quality documents at all times, while prioritizing/delivering the Immunovant 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 and consultant 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:
• B.S./B.A. degree.
• Minimum of 10 years of medical writing experience.
• Minimum 5 years of managing people and functions.
• 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, personalities and levels of management in a cross-functional manner.
• A style that can be flexible and integrate into a fast moving biotech
• 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.
• Strong expertise in troubleshooting and ability to deal with conflict
• 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; Immunovant’s headquarters is in New York City.
• Dynamic, interactive, fast-paced and entrepreneurial environment.
• Domestic or international travel is required (10-20%).
Apply Now
Apply Now
The Senior Director, Medical Writing Portfolio Management, coordinates and facilitates Medical Writing portfolio 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 communication of deliverables and ongoing assessment of resources to support he various teams and molecules. The ability to communicate concisely, succinctly to all levels of the organization is needed. The document scope included in this roles entails protocols, investigational brochures, Informed Consent Forms (ICFs), Pharmacy Manuals, as well as briefing books and regulatory responses.
This role will also:
• Collaborate with Project Management to enable delivery and resourcing to support ongoing study team documents
• Manage key submission documents and issues as they arise to facilitate any concerns and or solutions needed to streamline the writing process
• Collaborate with global regulatory affairs to manage and partner on strategic regulatory documents
• Oversight of the Medical Writing/Regulatory Department Standard Operating Procedures (SOPs) and processes with a Lense of right sizing for biotech
• Integration into clinical operations to facilitate a seamless integrations of Protocol amendments, IB updates, and any ICFs updates
Key Duties and Responsibilities:
• Authoring, facilitating review cycles, finalization of submission-ready specialty documents compliant with regulations and aligned with core messages on both batoclimab and IMVT-1402.
• 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.
• Supervise, develop and manage the Medical Writing Department.
• Ensure quality documents at all times, while prioritizing/delivering the Immunovant 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 and consultant 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:
• B.S./B.A. degree.
• Minimum of 10 years of medical writing experience.
• Minimum 5 years of managing people and functions.
• 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, personalities and levels of management in a cross-functional manner.
• A style that can be flexible and integrate into a fast moving biotech
• 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.
• Strong expertise in troubleshooting and ability to deal with conflict
• 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; Immunovant’s headquarters is in New York City.
• Dynamic, interactive, fast-paced and entrepreneurial environment.
• Domestic or international travel is required (10-20%).
Apply Now
Apply Now