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 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.
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
- 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
- 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.
EDUCATION, BEHAVIORAL COMPETENCIES AND
- 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
- 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 overnight trips with approximately 15% travel.
WHAT TAKEDA CAN OFFER YOU:
- 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 takedajobs.com.
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 http://www.takeda.us/careers/EEO_Policy_Statement.aspx
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