Posted to MedZilla on 3/18/2018

Takeda Pharmaceuticals

US-MA, Senior Manager Technical Writer 1703024-MZ


Are 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.

Here, 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 lead documentation preparation for regulatory submissions (CMC sections for BLA/MAA/NDA, briefing books, responses to questions from Health Authorities) and have responsibility for delivery of high quality submission-ready documentation.
  • Serve as the technical writing and editing expert to team members and manage continuous process improvements and ensure submission s compliance with regulatory requirements and internal quality standards.
  • Lead analytical/Quality Compliance 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, Technical 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 applicable.
  • Assure collaborative, proactive, and effective communication with internal teams and external vendors and partners.


  • Bachelors Degree in any Life Sciences and ten (10) years of relevant experience or Master s Degree in any Life Sciences with relevant laboratory coursework and eight (8) years of relevant experience.
  • Good knowledge and familiarity with technical writing requirements and experience 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 English.
  • Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
  • Ability to handle multiple tasks concurrently and in a timely fashion.
  • Willingness to travel to various meetings or training, this could include overnight trips with approximately 15% travel.
  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition 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
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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

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