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Job Details

Senior Manager Technical Writer

Company name
Takeda Pharmaceuticals U.S.A., Inc.

, MA

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US-MA, Senior Manager Technical Writer


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you looking for a patient-focused company that will inspire you and support

your career? If so, be empowered to take charge of your future at Takeda. Join

us as a Senior Manager, Technical Writer, Quality Assurance in our Cambridge, MA office.


everyone matters and you will be a vital contributor to our inspiring, bold

mission. As a Technical Writer working on the Quality Assurance team, you will

be empowered to lead and prepare documentation

for regulatory submissions and a typical day will include:



The Senior Manager, Technical Writer,

Quality Assurance

will l


documentation preparation for regulatory submissions (CMC sections for

BLA/MAA/NDA, briefing books, responses to questions from Health Authorities)


have r



for delivery of high quality submission-ready documentation.


as the

technical writing and editing expert to team

members and manage continuous process improvements

and e

nsure submission s compliance with regulatory requirements and internal

quality standards.

Lead analytical/Q




activities during the technology transfer

and qualification of new manufacturing sites.

Review and approve validation documentation; assure high quality of

generated results and data integrity.

Partner with GRA CMC, Tech


Operations and Supply Operations groups to ensure high quality and

timely delivery of submission ready documentation.



Lead preparation of CMC sections in CTD format for new submissions and

post-approval changes.

Lead compilation of responses to questions from Health Authorities.

Provide technical expertise for CMC-related questions.

Review validation documentation, study protocols and reports to maintain

compliance and assure high quality of generated data.

Oversee testing for process validation activities at multiple CROs, as


Assure collaborative, proactive, and effective communication with

internal teams and external vendors and partners.



Bachelors Degree in any Life Sciences and

ten (


years of relevant experience or Master s

Degree in any Life Sciences with relevant laboratory coursework and

eight (


years of relevant experience.

Good knowledge and familiarity with technical writing requirements

and e

xperience with small molecule and biologic products.

Understanding of CMC regulatory requirements across major markets.

Good interpersonal skills and ability to work effectively and

efficiently in a team environment.

Excellent written, oral and presentation communication skills in


Must have the following personal

attributes: integrity and trust, work

ethic, sound judgment, intellectual honesty, pragmatism, courage and


Ability to handle multiple tasks concurrently and in a timely fashion.


Willingness to travel to various meetings or training, this could

include overn

ight trips with

approximately 15% travel.


401(k) with company

match and Annual Retirement Contribution Plan


reimbursement Company match of charitable contributions

Health &

Wellness programs including onsite flu shots and health screenings

Generous time off

for vacation and the option to purchase additional vacation days

Community Outreach Programs

Empowering Our People to Shine

Learn more at

Takeda is an EEO

employer of minorities, women, disabled, protected veterans, and considers

qualified applicants with criminal histories in accordance with applicable

laws. For more information, visit

No Phone Calls or

Recruiters Please.


Please visit our website at

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If a direct employer requests that you go to their web site and complete your application there in order to be

considered, please do so. Applications for all positions are subject to each employer's specific requirements.

Company info

Takeda Pharmaceuticals U.S.A., Inc.
Website :

Company Profile
As a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals U.S.A., Inc. (TPUSA) is among the top 15 pharmaceutical companies in the United States. TPUSA was founded in 1998 to accelerate Takeda's global expansion into the U.S. market. Takeda's U.S. clinical development activities are conducted via Takeda Development Center Americas, Inc., which has a robust pipeline of compounds in multiple therapeutic areas including metabolic and cardiovascular diseases, central nervous system, respiratory and immunology, oncology and general medicine. Striving toward better health is at the center of everything we do. Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, but remains ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine.The spirit of our commitment extends to our employees, partners and the larger community.

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