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Manager/Sr. Manager OTAU Business Operations

Company: Takeda Pharmaceutical
Location: West Nyack
Posted on: September 21, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. 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 deliver Better Health and a Brighter Future to people around the world.Here, you will be a vital contributor to our inspiring, bold mission.Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.OBJECTIVES: - This individual will be responsible for supporting novel and exciting oncology pharmacology as a member of the Scientific Affairs department, working with research staff/Scientific Affairs group to support IND centric quality initiatives for study implementation/conduct/documentation. - This high level quality documentation is necessary for program technical reports and all oncology scientific data supporting the oncology portfolio.

  • Manages quality scientific documentation for project teams as well as group functions
  • Partners with RDQA, Regulatory Affairs, as well as multiple cross functional project team members on necessary requirements
  • Works with data system owners to capture and improve data and processes
  • Technical Report writing and ROP's to improve scientific practice behind the data headed to agencies - - - - - - - - -ACCOUNTABILITIES: - Partnering with oncology pharmacology project teams to support Scientific Affairs with quality documentation, including ELN documentation/utilization supporting regulatory submissions. - Preparation of technical reports/timelines and process around supporting multiple regulatory submissions - Ensure the quality of any external study data and reports coming from contract research organizations; sufficient to meet all Takeda and agency compliance standards. Train and support staff around critical data platforms such as GENI, StudyLog, BioReg, Mosaic, StarDoc etc -- for traceability and reproducibility Support robust scientific study design for project teams headed toward IND Supportive approach with many critical cross functional partners Manage OTAU Resource SharePoint Site and other business critical IT needs, ensuring effective and efficient collaboration within the TAU and with cross-divisional/functional stakeholders including the IT department. Identify process improvement opportunities and initiate and manage plans to complete the improvement initiative. As time allows, support ROP's for standardization across scientific processEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: -Education/Experience/Competencies
    • BS (Biology, Pharmacology, Toxicology or other life science) with a minimum of 5 years experience in a related field
    • Good understanding of pharmaceutical development, statistics and experimental design is expected
    • Proficiency in MS Word, Excel and PowerPoint is expected, and familiarity with document management and storage systems (ELN, EDMS such as Mosaic/StarDoc) is a plus
    • Experience writing documents for regulatory submissions is a plus
    • Ability to handle multiple priorities, build strong relationships across all levels
    • Strong communication skills with a proven track record of influencing othersWHAT 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 ProgramsIn accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.#LI-JT1EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Tenafly , Manager/Sr. Manager OTAU Business Operations, Executive , West Nyack, New Jersey

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