Takeda Pharmaceuticals/Randstad Work Values

Daily Duties at Takeda Pharmaceuticals/Randstad:

• Planned and provided medical writing and project management for all clinical trial transparency activities • Executed registration and results disclosure activities for all company sponsored clinical research studies globally in accordance with all applicable national and local databases. • Actively monitored legal and regulatory requirements, and continuously improved Takeda processes and systems for clinical trial disclosure. • Participated on relevant global project teams and task forces and consults with study teams to provide expert guidance on public disclosure processes and requirements and information, including international regulatory/legal requirements for registration and results posting (including process, content, and format) • Had responsibility for assembly of (or managing the assembly of) clinical study postings, including (but not limited to) registering and maintaining registrations and posting results on clinicaltrials.gov, EUCTR, and other applicable websites, under the direction of Director/Manager of GCSD • Ensured registration and results disclosure activities were harmonized worldwide, and completed with all applicable US and international laws, regulations, and requirements, as well as industry and Takeda policies and principles • Collaborated with global study teams, including (but not limited to) Statistics, Clinical Operations, Regulatory Affairs, Legal, Publications, Global Medical Affairs, Pharmacovigilance, Clinical Science, Clinical Pharmacology, Publications, as well as local operating companies (LOCs) worldwide to ensure integrity and consistency of disclosed clinical trial information • Developed and executed the Global Registration and Results Disclosure Plans for each clinical study • Provided associated vendor oversight to ensure quality and consistent global study registrations and disclosures • Ensured disclosure records are accurate, complete, and retained for proof of regulatory compliance • Provided training and strategic information on global data transparency and disclosure to study teams and to support disclosure compliance

What they like about Takeda Pharmaceuticals/Randstad:

Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.

Tags

Medical writing, technical writing, MS Office, Documentum, Adobe Suite, project management, publications

Skills

AMA Manual of Style, DSM-IV-TR, CME Guidelines, ICH Guidelines, Clinical Trial Disclosure, Manuscripts, Slide Decks, Posters, Abstracts, Clinical Study Reports, Protocol and Amendments, Synopses

These are some of the questions we asked our climbers about their experiences with Takeda Pharmaceuticals/Randstad: