Manager, Nonclinical Writing Document Lifecycle Management

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Job Description

OBJECTIVES/PURPOSE

The Manager, Nonclinical Writing Document Lifecycle Management is responsible for:

• Supporting the management of internally-generated nonclinical protocols, reports, and other such documentation during the drug development lifecycle.
• Supporting the intake and archiving of externally-generated nonclinical documentation.
• Ensuring alignment with regulatory requirements.
• Enhancing technical capabilities.
• Optimizing processes related to document management within the nonclinical environment.

ACCOUNTABILITIES

• Manage the development and maintenance of nonclinical documents. This includes but is not limited to: study & report number generation, template assignment, workflow management, electronic archiving, and providing process guidance to functional area partners.
• Collaborate with NCW team members, leadership, and both internal and external stakeholders to optimize document life cycle management.
• Collaborate with relevant stakeholders to ensure documents align with regulatory submission requirements, internal guidelines, and project timelines.
• Provide guidance and support to internal and external stakeholders on usage of NCW electronic document management and study tracking systems.
• Assist with management of the nonclinical hardcopy archive.
• Demonstrate ability to work independently.
• Escalate issues when necessary to maintain project timelines and performance standards.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor’s degree or equivalent in a scientific discipline is preferred. An advanced degree is recommended.
• A minimum of 5 years in a scientific or technical environment, with a focus on document life cycle management or related fields.

Skills & Knowledge

• Strong project management and organizational skills.
• Ability to collaborate effectively with cross-functional teams and stakeholders.
• Strong communication skills, both written and verbal, to deliver clear reports and status updates.
• Excellent problem-solving and decision-making abilities.
• Ability to manage multiple projects simultaneously while meeting deadlines.
• Strong understanding of regulatory guidelines and document management standards.
• Ability to analyze trends and develop improvement opportunities.

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:

$111,800.00 - $175,670.00

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.