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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Documentation Lead in our Cambridge, MA office.

At Takeda, we develop innovative medicines and we develop people! We are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower all colleagues to realize their professional and personal potential through their life-changing work and interpersonal relationships. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliverBetter Health and a Brighter Futureto people around the world.

At Takeda, you will be a vital contributor to our inspiring, bold mission and high-performing culture.

OBJECTIVES

• Support the management of internally generated nonclinical protocols, reports, and/or regulatory submission documents during the drug development lifecycle; responsibilities include but are not limited to formatting, editing, publishing, and operational and system-related tasks.
• Perform comprehensive quality checks (QC) and content verification for nonclinical content within regulatory submission documents in order to achieve the highest quality from a technical, regulatory, and compliance perspective.
• Assist with the management and tracking of both submission and nonsubmission supporting Nonclinical documentation within the electronic document management systems (both regulatory and non-regulatory), and within the GLP hardcopy archive.

ACCOUNTABILITIES

• Edit and format internally-generated nonclinical protocols, amendments, and deviations.

• Format and copy edit internally generated nonclinical reports and amendments.
• Perform publishing to submission-ready standards on all Nonclinical submission documentation
• Management of nonclinical documentation (reports, protocols, and related documents) within the applicable electronic document management system (EDMS).

• Management of study and report records in the Global study tracking database.
• Assignment of nonclinical study and report numbers and templates.
• Management of ongoing system workflows
• Content verification and QC of Nonclinical content within submission documents back to the source.
• Creation of document plans for global regulatory submissions.
• Creation of Nonclinical tabulated summaries for global regulatory submissions.
• Assist with business development-related tasks (eg: creation of indices of nonclinical studies for partnerships, QC of documentation received for transfer).
• Assist the nonclinical archivist with record management as appropriate.
• Maintain compliance with applicable GLP regulations and SOPs.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

• BS(preferably in technology, sciences or information-related field).

• Previous experience in nonclinical sciences and compiling nonclinical documentation is a plus.
• A team player with excellent communication skills and advanced computer literacy.
• Strong knowledge of Microsoft Word Suite (Word, Excel, Power Point).
• Experience with EDMS systems.
• Experience working in a regulated environment
• Ability to consistently meet deadlines.
• Ability to work on several documents at the same time, high attention to detail and accuracy.
• Proven ability to work independently and effectively handle multiple projects.
• Effective interpersonal, oral and written communication skills.
• Highly effective organizational, prioritization, and time-management skills.

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

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