Associate Director, Medical Writing - Remote

Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director Medical Writing where you will be responsible for medical writing activities for a program or multiple programs within a therapeutic area depending on the scope and stage of clinical development and may or may not have direct reports. With minimal oversight, provides strategic direction to cross-functional project teams to ensure that clinical regulatory documents (e.g., investigators' brochures, study protocol and amendments, study reports, marketing authorization submission documents) accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements. You will write and/or provide direction and leadership to other writers to ensure the timely delivery of high-quality documents that are scientifically rigorous, logically organized, and which provide accurate data presentation and interpretation. In addition to project responsibilities, the Associate Director, Medical Writing is responsible for non-project related activities (e.g., subject matter expert for a process), and generally leads or participates on departmental or cross-functional initiatives designed to establish best practices and efficient cross-functional collaboration. You will also contribute to therapeutic area project teams as the medical writing expert for regulatory submission documents. Collaborate with all Takeda regions to ensure a medical writing regulatory document strategy is created and executed upon for all products within the area of responsibility. As part of the Medical Writing team, you will report to the Medical Writing Director. How you will contribute: Lead the writing strategy providing expertise including organization, content, timelines, and resource requirements. Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications. Coordinates the activities of Takeda employees, contract employees and vendors (on-site or external), provides review and substantive editing of contributions, and ensures resolution of issues. Within designated therapeutic area, manages deliverables and preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements, as well as Takeda requirements and processes across development programs. Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards). As required, serves as lead writer for important regulatory response documents and key components of regulatory submissions. The Associate Director, Medical Writing is seen as an expert in medical writing and performs work independently with minimal supervision. Minimum Requirements/Qualifications: Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor’s degree is required. At least 10 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company is required. Experience as lead writer for key documents included in major US and/or international regulatory submissions required. Experience managing writing activities for a major US or international regulatory submission (project or people management) preferred. Demonstrated ability to understand and interpret clinical and scientific data with minimal oversight; ability to define data presentation to meet key messages developed by the clinical team. Demonstrated ability to independently lead the development, review, and approval of all clinical document types (i.e., those typically developed by MW) and the ability to identify any new or unique document types which may require a different approach. Demonstrated ability to appropriately manage resourcing across assigned projects and negotiate workload priorities. Demonstrated ability to establish detailed timelines for completion of assigned projects and ensure efficient, timely completion. Excellent project management skills including in depth understanding of clinical timelines (study and submission level) and working knowledge of roles of other functional areas and the interdependencies among groups. Ability to interact effectively with team members/leaders and senior leaders at Takeda proactively facilitating effective information exchange/communication (including problem solving and issue resolution). Working knowledge of current global regulatory requirements/guidelines applicable to clinical research (e.g., GCP). Working knowledge of the regulatory guidance(s) regarding content for various document types including, but not limited to, ICH E3 (CSRs), ICH E6 (IBs), ICH M4, ICH E2E, EMA guidance on RMPs. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.

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