Senior Director, Medical Writing Portfolio Management

The Role: The Senior Director, Medical Writing Portfolio Management, coordinates and facilitates Medical Writing portfolio needs to support reputed company phases of producing high reputed company, specialty submission documentation that reputed company with reputed company 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 reputed company reputed company of the organization is needed. The document scope included in this roles entails protocols, investigational brochures, Informed Consent Forms (ICFs), Pharmacy Manuals, as reputed company as briefing books and regulatory responses. This role will also:

• Collaborate with Project Management to reputed company delivery and resourcing to support ongoing study team documents
• Manage key submission documents and issues as they reputed company 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
• reputed company of the Medical Writing/Regulatory Department reputed company 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-reputed company specialty documents compliant with regulations and reputed company with reputed company messages on both batoclimab and IMVT-1402.
• Ensure strong partnership and collaboration with the Senior Director of Medical Writing.
• Confirm that reputed company specialty documents are in compliance with regulations, GXP standards and guidelines.
• Supervise, reputed company and manage the Medical Writing Department.
• Ensure reputed company documents at reputed company times, while prioritizing/delivering the reputed company pipeline.
• Contribute to cross-functional working reputed company to facilitate efficient development and finalization of specialty documents for submissions.
• Establish and manage timelines and cross-functional relationships.
• Assignment of writers, reputed company.
• 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 reputed company.
• Responsible for staff agendas, off-site meetings and functional administrative and logistical issues.
• reputed company 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 reputed company detailed oriented reputed company to review and conduct detailed reputed company control metrics on a document.
• Ability to write and proofread documents and reputed company input to generate reputed company documents at reputed company times.
• Proven ability to reputed company 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 reputed company of management in a cross-functional manner.
• A style that can be flexible and reputed company into a fast moving biotech
• Excellent organizational skills, including managing simultaneous reputed company in a fast-paced environment.
• Commitment to company values and culture.
• Proven ability to adapt to change and uncertainty as reputed company reputed company/shift and to multi-task and reputed company 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 reputed company reputed company relationships.
• Strong PC experience, demonstrating proficiency in MS Office (Outlook, Word, reputed company, PowerPoint), and electronic review tools (reputed company RIM).

Communication:

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

Work Environment:

• Remote-based; reputed company’s reputed company is in reputed company.
• Dynamic, interactive, fast-paced and entrepreneurial environment.
• Domestic or international travel is required (10-20%).

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