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 Documentation Associate, Nonclinical Writing and Documentation, in our Cambridge, Massachusetts office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Documentation Associate, Nonclinical Writing and Documentation working on the Nonclinical Writing & Documentation team, you will be empowered to support drug development through production, monitoring, and archiving of nonclinical protocols, reports, and documents for regulatory filings.
- The Documentation Associate, Nonclinical Writing and Documentation is responsible for documentation formatting and document management activities for nonclinical studies. This individual will support drug development from discovery through market and beyond, monitoring nonclinical protocols, reports, and documents intended for worldwide regulatory filings. Primary responsibilities include: formatting documentation to required standards, report level publishing, eCTD hyperlinking and QC checks, oversight and/or technical support of nonclinical document preparation for electronic submissions. This incumbent will perform template maintenance. S/he will be performing regulated related responsibilities that support GLP nonclinical study protocol and report document life cycle coordination. S/he will support regulatory submission-related operational tasks. S/he will perform general quality compliance.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- AS/BS (preferably in technology, sciences or information-related field) is required. A minimum 2 years-experience in a regulated environment with hands-on experience in document management, submission and/or large-volume document preparation. A team player with excellent communication skills and advanced computer literacy is required. Experience in biological research and development is preferred. Proven ability to work independently and effectively handle multiple projects. The successful candidate is required to have strong knowledge of word processing applications, database structure, multiple computer applications: electronic document management systems (Documentum or similar applications), EndNote, Oracle, SharePoint. Ability to work on several documents at the same time, high attention to detail and accuracy, ability to consistently hit deadlines, excellent written and oral communication skills. High level of competency required in teamwork for departmental and cross-functional project teams. Fundamental knowledge of worldwide regulatory submissions guidance a plus.
- The position is located in our Cambridge, Massachusetts Office and minimal travel is required <5%.
WHAT TAKEDA CAN OFFER YOU:
- 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
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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