Associate Director, Medical Writing Regulatory Submissions

Takeda; Warszawa; Hybrid; PLN 402,000 - 553,000; Full time

Job summary

Takeda in Lodz, Poland is seeking an Associate Director, Medical Writing to lead regulatory document strategy and ensure rigorous, compliant submissions across programs. You will mentor writers, collaborate across regions, and guide timelines, content, and resource planning.

The role emphasizes strategic direction, high-quality data presentation, and independence with minimal supervision, supporting FDA and other agencies while advancing Takeda's therapeutic programs.

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 (ie, 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.
• Strong oral and written presentation skills.
• 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 (eg, 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).

Responsibilities

• Contributes to therapeutic area project teams as the medical writing expert for regulatory submission documents.
• Collaborates with all Takeda regions to ensure a medical writing regulatory document strategy is created and executed upon for all products within area of responsibility.
• The Associate Director, Medical Writing leads 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.

Skills

Medical writing

Regulatory submissions

Project management

Cross-functional collaboration

Excellent communication

Education

Bachelor's degree required

Advanced degree preferred

Job description

Takeda in Lodz, Poland is seeking an Associate Director, Medical Writing to lead regulatory document strategy and ensure rigorous, compliant submissions across programs. You will mentor writers, collaborate across regions, and guide timelines, content, and resource planning.

The role emphasizes strategic direction, high-quality data presentation, and independence with minimal supervision, supporting FDA and other agencies while advancing Takeda's therapeutic programs.