Non-Clinical Writing Lead

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Job Description

Objective / Purpose:

The Non-Clinical Writing (NCW) team delivers high-quality regulatory and technical documentation for Takeda's Non-Clinical Safety, Drug Discovery Units (DDU) and the Drug Metabolism Pharmacokinetics & Modeling (DMPK&M) groups. This documentation enables robust decision-making as assets progress through Takeda's Research pipeline, ensuring alignment with development goals and regulatory standards.

The Non-Clinical Writing Lead leads the NCW team and oversees a team of 5-10 direct reports. This role is responsible for driving excellence in non-clinical documentation quality and submission timelines across all Takeda R&D programs. Close collaboration with above-mentioned stakeholders is expected, to cultivate a culture of teamwork and efficiency. The Lead ensures seamless operations and Takeda’s ability to deliver impactful non-clinical writing services across R&D. The Lead also serves as a member of the Non-Clinical Safety & Pharmacology (NCSP) leadership team.

Accountabilities:

• Lead team of 8-10 employees in delivering high-quality non-clinical documentation, ensuring robust regulatory submissions that support Takeda R&D programs across therapeutic areas

• Oversee and ensure compliance with internal policies, GxP standards, and regulatory requirements, promoting inspection readiness for all regulated activities

• Develop and adapt operating models, standards, and strategies to optimize documentation quality, process efficiency, and pipeline acceleration

• Build and sustain collaborative partnerships with direct stakeholder groups (NCSP, DMPK&M, DDUs, TAUs) and drive process improvements across Research functions

• Offer strategic direction on enabling technologies, staffing models, and external resource usage, ensuring capacity and scalability during increased workload periods

• Create and maintain a culture of delivery excellence, inspiring team members and optimizing group performance to meet organizational objectives

• Manage staffing, recruitment, training, mentoring, and performance evaluation processes to sustain a highly effective team

• Ensure efficient electronic library management

• Lead continuous improvement initiatives to enhance process optimization, non-clinical documentation standards, and portfolio timeline delivery within Takeda Research

Education & Competencies (Technical and Behavioral):

• Minimum 10 (or 15) years’ experience in medical writing within a pharmaceutical or Contract Research Organization (CRO)

• Minimum 5 years’ experience leading teams

• Advanced degree related to pharmacology, toxicology, or pharmacokinetics, or other related scientific discipline preferred

• Experience in pharmaceutical or biotech product development across numerous modalities, with direct involvement in regulated studies related to pharmacology, toxicology, or pharmacokinetics, demonstrating a broad understanding of the drug development process

• Strong leadership capability with advanced skills in team building, motivating, and developing people

• Ability to influence and work effectively with various business partnerships, regions, and cultures

• Demonstrated ability to prioritize, manage multiple programs within strict regulatory and compliance deadlines, and lead internal/external and scientific teams to regulatory submission aims

• Thorough understanding of regulatory guidelines related to global submissions and submission content (e.g., FDA/EMA/PMDA regulations; ICH guidance and familiarity with GLP/GCP requirements)

• Demonstrated critical thinking skills and strong attention to details.

• Thrives in an agile and high-pace environment

• Ability to comprehend and synthesize complex data, identify issues and trends and develop and implement solutions

• Excellent communicator with strong written and verbal presentation skills

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Boston, MA

U.S. Base Salary Range:

$174,500.00 - $274,230.00

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.