Senior Medical Writing Lead – Regulatory Submissions

Takeda; Łódź; Hybrid; PLN 4,021,000 - 5,529,000; Full time

Job summary

Takeda Lodz in Poland is seeking an Associate Director of Medical Writing to lead writing strategy for regulatory submissions and guide cross-functional teams through complex documents. You will work with writers, vendors, and internal partners to ensure accuracy, consistency, and regulatory alignment across programs.

The role requires extensive experience in clinical/regulatory writing, leadership of writing activities, and the ability to operate in a hybrid work model within a global

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.

Responsibilities

• Contributes to regulatory submission documents as medical writing expert for the area.
• Leads writing strategy and ensures timely, high-quality documents.
• Coordinates activities of writers, vendors, and reviewers across regions and functions.

Skills

Regulatory writing leadership

Cross-functional collaboration

Strategic writing direction

Education

Advanced degree in scientific/clinical/regulatory field

Bachelor's degree required

Job description

Takeda Lodz in Poland is seeking an Associate Director of Medical Writing to lead writing strategy for regulatory submissions and guide cross-functional teams through complex documents. You will work with writers, vendors, and internal partners to ensure accuracy, consistency, and regulatory alignment across programs.

The role requires extensive experience in clinical/regulatory writing, leadership of writing activities, and the ability to operate in a hybrid work model within a global