Non-Clinical Writing Lead Position Available In Suffolk, Massachusetts

Job Description:

By clicking the “Apply” button, I understand that my employmentapplication process with Takeda will commence and that theinformation I provide in my application will be processed in linewith Takeda’s Privacy Notice and Terms of Use . I further attestthat all information I submit in my employment application is trueto the best of my knowledge. Job Description Objective /

Purpose:

The Non-Clinical Writing (NCW) team delivers high-qualityregulatory and technical documentation for Takeda’s Non-ClinicalSafety, Drug Discovery Units (DDU) and the Drug MetabolismPharmacokinetics & Modeling (DMPK&M) groups. This documentationenables robust decision-making as assets progress through Takeda’sResearch pipeline, ensuring alignment with development goals andregulatory standards.

The Non-Clinical Writing Lead leads the NCWteam and oversees a team of 5-10 direct reports. This role isresponsible for driving excellence in non-clinical documentationquality and submission timelines across all Takeda R Dprograms. Close collaboration with above-mentioned stakeholders isexpected, to cultivate a culture of teamwork and efficiency. TheLead ensures seamless operations and Takeda’s ability to deliverimpactful non-clinical writing services across R D. The Leadalso serves as a member of the Non-Clinical Safety & Pharmacology(NCSP) leadership team.

Accountabilities:

Lead team of 8-10employees in delivering high-quality non-clinical documentation,ensuring robust regulatory submissions that support Takeda R Dprograms across therapeutic areas Oversee and ensure compliancewith internal policies, GxP standards, and regulatory requirements,promoting inspection readiness for all regulated activities Developand adapt operating models, standards, and strategies to optimizedocumentation quality, process efficiency, and pipelineacceleration Build and sustain collaborative partnerships withdirect stakeholder groups (NCSP, DMPK&M, DDUs, TAUs) and driveprocess improvements across Research functions Offer strategicdirection on enabling technologies, staffing models, and externalresource usage, ensuring capacity and scalability during increasedworkload periods Create and maintain a culture of deliveryexcellence, inspiring team members and optimizing group performanceto meet organizational objectives Manage staffing, recruitment,training, mentoring, and performance evaluation processes tosustain a highly effective team Ensure efficient electronic librarymanagement Lead continuous improvement initiatives to enhanceprocess optimization, non-clinical documentation standards, andportfolio timeline delivery within Takeda Research Education &Competencies (Technical and Behavioral): Minimum 10 (or 15) years’experience in medical writing within a pharmaceutical or ContractResearch Organization (CRO) Minimum 5 years’ experience leadingteams Advanced degree related to pharmacology, toxicology, orpharmacokinetics, or other related scientific discipline preferredExperience in pharmaceutical or biotech product development acrossnumerous modalities, with direct involvement in regulated studiesrelated to pharmacology, toxicology, or pharmacokinetics,demonstrating a broad understanding of the drug development processStrong leadership capability with advanced skills in team building,motivating, and developing people Ability to influence and workeffectively with various business partnerships, regions, andcultures Demonstrated ability to prioritize, manage multipleprograms within strict regulatory and compliance deadlines, andlead internal/external and scientific teams to regulatorysubmission aims Thorough understanding of regulatory guidelinesrelated to global submissions and submission content (e.g.,FDA/EMA/PMDA regulations; ICH guidance and familiarity with GLP/GCPrequirements) Demonstrated critical thinking skills and strongattention to details. Thrives in an agile and high-pace environmentAbility to comprehend and synthesize complex data, identify issuesand trends and develop and implement solutions Excellentcommunicator with strong written and verbal presentation skillsThis position is currently classified as “hybrid” in accordancewith Takeda’s Hybrid and Remote Work policy Takeda Compensation andBenefits Summary We understand compensation is an important factoras you consider the next step in your career. We are committed toequitable pay for all employees, and we strive to be moretransparent with our pay practices.

For Location:

Boston, MA U.S.

Base Salary Range:

$174,500.00 – $274,230.00 The estimated salaryrange reflects an anticipated range for this position. The actualbase salary offered may depend on a variety of factors, includingthe qualifications of the individual applicant for the position,years of relevant experience, specific and unique skills, level ofeducation attained, certifications or other professional licensesheld, and the location in which the applicant lives and/or fromwhich they will be performing the job.

The actual base salaryoffered will be in accordance with state or local minimum wagerequirements for the job location. U.S. based employees may beeligible for short-term and/or long-termincentives. U.S.basedemployees may be eligible to participate in medical, dental, visioninsurance, a 401(k) plan and company match, short-term andlong-term disability coverage, basic life insurance, a tuitionreimbursement program, paid volunteer time off, company holidays,and well-being benefits, among others. U.S.based employees are alsoeligible to receive, per calendar year, up to 80 hours of sicktime, and new hires are eligible to accrue up to 120 hours of paidvacation. EEO Statement Takeda is proud in its commitment tocreating a diverse workforce and providing equal employmentopportunities to all employees and applicants for employmentwithout regard to race, color, religion, sex, sexual orientation,gender identity, gender expression, parental status, nationalorigin, age, disability, citizenship status, genetic information orcharacteristics, marital status, status as a Vietnam era veteran,special disabled veteran, or other protected veteran in accordancewith applicable federal, state and local laws, and any othercharacteristic protected by law. Locations Boston, MA Worker TypeEmployee Worker Sub-Type Regular Time Type Full time Job Exempt YesIt is unlawful in Massachusetts to require or administer a liedetector test as a condition of employment or continued employment.

An employer who violates this law shall be subject to criminalpenalties and civil liability.