Skip to main content

Search Jobs

Director Medical Writing, Vaccines

Takeda Pharmaceuticals

$166,545.00 - 167,060.00 per year

Full-time

59 Tremont St

Boston, MA 02297

Job Description
The Director Medical Writing is responsible for strategically planning and resourcing the medical writing (MW) deliverables that support Takeda s business objectives for clinical development for VBU with multiple compounds through all phases of development.

This position provides medical writing therapeutic leadership responsible for the oversight and execution of the medical writing strategy in line with global medical writing objectives as well as Clinical Program Leadership and serves as a senior strategic Medical Writing resource to clinical development teams for its vaccine development activities.

Director Medical Writing, Vaccines

Responsible for Medical Writing global submission timelines/planning/forecasting and budget management for assigned therapeutic area. Responsible for administrative budget and for direct reports.

Responsible for MW vendor oversight and operational strategy, contract compliance, quality and timeliness of deliverables, and continuous improvement related to outsourced clinical development MW activities.
Represents Global Medical Writing at CPT level as responsible point of contact for CPTs, internal stakeholders and vendors.
Able to integrate business and science to make strategic decisions; assume responsibility for medical writing issues relative to global development programs, and serves as responsible contact for team and functional managers. This is a leadership role that will be responsible for developing and implementing global medical writing strategies, operational plans and innovative solutions for all medical writing activities. He/she will lead high performing in-house and outsourced medical writing teams in the delivery of high quality regulatory writing services in accordance with applicable regulatory regulations.
Will oversee the strategies that fully support global regulatory submissions and global clinical development programs with respect to content, processes, and standards, and enhance quality and optimize production time for all regulatory documents.
The Director Medical Writing will be responsible for medical writing regulatory submissions that may be large, complex, high risk and/or of business importance to Takeda, requiring multi-functional leadership experience and skills to achieve submission goals. More than one program may be assigned.

Provides global medical writing strategic direction and leadership for VBU across multiple compounds
Responsible for developing, implementing and assuring execution of strategic global medical writing
plans.

Accountable for overall direction of multiple, large, complex regulatory submissions.
Provides oversight for the development, approval, and implementation of
medical writing processes, standards, style guidelines and templates.

Guides medical writing activities (including document preparation and/or production) for assigned regulatory submissions or projects.
Formulates writing strategy for key documents, including organization, content, timelines, and resource requirements; ensures that needs (e.g. headcount, funding, time) are appropriately represented to relevant teams and management.
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.
Provides leadership on functional teams that address requirements or issues related to document preparation and production.
Reviews availability of sufficiently qualified vendor resources on a regular basis, contribute to planning of future vendor resource needs; generally through departmental resource reviews, vendor assessment strategies, including vendor forecasts.
Provides oversight external vendors for implementing and assuring execution of strategic medical writing plans. - Coordinates the activities of Takeda and contract employees (on-site or external), provides review and substantive editing of contributions, and ensures resolution of issues.
Oversees compliance with relevant internal and external standards, and maintains a functional group that meets or exceeds industry standards.
Align project and resource priorities that with the business objectives and establishes, communicates and executes plans that drive toward goal achievement.
Works with medical writing leadership to deploy resources and develop processes to ensure a highly functional department.
Adheres to and enforces policies and applicable ethical, regulatory, and clinical standards.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

Minimum BS degree in life science, English or other applicable scientific degree with MS, PhD or MD preferred.
10+ years of applicable clinical research and medical writing experience.
5+ years of line or matrix management experience.
Significant previous experience leading the medical writing activities for major global submissions
Scientific and medical experience/expertise sufficient to understand and be conversant on key issues in relevant therapeutic areas.
Highly advanced understanding of the clinical development process and preparation of the clinical sections of marketing applications and other regulatory submissions.
Minimum 5 years experience managing writing activities for major US, EU and/or other ROW international regulatory submissions (project and people management, management of overall resources).
Expertise in global eCTD submissions required.
Phase 1-4 experience required.
Demonstrated excellence in leading global eCTD submissions, matrix leadership skills and strategic problem-solving ability.
Knowledge and Skills:

Expertise in global regulatory and compliance requirements and principles of global drug development from IND/CTA through submission, and ability to relate individual elements of clinical development programs to specific needs for document preparation and production.
Scientific and medical experience/expertise sufficient to understand and be conversant on key issues in relevant therapeutic areas.
Expertise for all types of regulatory submission documents including but not limited to, Investigator Brochures and updates, clinical study reports, NDA/MAA eCTD summary documents, briefing documents, response documents, pediatric investigational plans, and other IND/CTA or global regulatory submission documents
Advanced knowledge of ICH and GCP guidelines, and global regulatory requirements and processes as related to document content, organization, format, and production.
Overall understanding of technologies required for document preparation and production, and ability to identify opportunities to implement value-added technology.
Understanding of resources (time, headcount, expertise) and inputs required for preparation and production of documents supporting global regulatory submissions and global clinical development programs.
Ability to lead and motivate teams.
Excellent oral and written communications skills and ability to communicate effectively across management, functional areas, and geographical locations.
Ability to anticipate and manage the evolution of needs, and effectively drive the implementation of new technology and process to increase efficiency or address changes in requirements for document preparation and production.


Associated topics: administrative officer, administrative staff, administrative support, asso, beverage, facilities, front desk, food, operation, operational support