Director, Medical Writing Team Lead Marketed Products Group

Company: Takeda Pharmaceutical
Location: Hackensack
Posted on: November 12, 2021

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 DescriptionDirector, Medical Writing Team Lead Marketed Products GroupAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director, Medical Writing in our Cambridge, MA office.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.As a Director, Medical Writing working on the Medical Writing team, you will be responsible for developing and implementing global medical writing strategies, operational plans and innovative solutions for all medical writing activities. Promotes and/or leads departmental or cross-functional initiatives designed to establish highly efficient processes, best practices, and productive cross-functional collaboration. Leads high performing in-house and outsourced medical writing teams in the delivery of high-quality documents and guidance, in accordance with applicable regulatory regulations. -A typical day will include:POSITION OBJECTIVES:

• Responsible for strategically planning and resourcing the medical writing (MW) deliverables that support Takeda's business objectives for clinical development for a therapeutic area unit (TAU) with multiple compounds through all phases of development.-
• Provides strategic direction to cross-functional project teams to ensure that clinical regulatory documents accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements, and that continuity and consistency of clinical data are maintained from concept to licensing and disclosure.
• Responsible for Medical Writing global submission timelines/planning/forecasting and budget management for assigned therapeutic area.-
• Vendor oversight and operational strategy, contract compliance, quality and timeliness of deliverables, and continuous improvement related to outsourced clinical development MW activities.
• Represents Global Medical Writing at therapeutic area level as responsible point of contact for GPTs, internal stakeholders and vendors; able to integrate business and science to make strategic decisions.
• Functional leadership for medical writing, including hiring, training, staff assignments, coaching, mentoring, and performance management (including compliance) assume responsibility for medical writing issues relative to global drug development programs, and serves as responsible contact for team and functional managers.
• Oversee the strategies that fully support global regulatory submissions and global clinical development programs with respect to content, processes, and standards.POSITION ACCOUNTABILITIES:
  • Provides global medical writing strategic direction and leadership for responsible therapeutic area across multiple compounds.
  • Responsible for developing, implementing and assuring execution of strategic global medical writing plans, including oversight of external vendors to accomplish these aims.
  • Accountable for overall direction of multiple, large, complex regulatory submissions.
  • Provides oversight for the development, approval, and implementation of medical writing processes, standards, style guidelines and templates.
  • Reviews availability of sufficiently qualified vendor resources on a regular basis, contributes to planning of future vendor resource needs, generally through departmental resource reviews, vendor assessment strategies, including vendor forecasts.
  • Oversees compliance with relevant internal and external standards and maintains a functional group that meets or exceeds industry standards.-
  • Aligns project and resource priorities that with the business objectives and establishes, communicates and executes plans that drive toward goal achievement.
  • Works with medical writing leadership to deploy resources and develop processes to ensure a highly functional department. Adheres to and enforces policies and applicable ethical, regulatory, and clinical standards.EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
    • Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor's degree is required.
    • At least 12 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company is required, with at least 5 years of direct line management or matrix experience.
    • Global regulatory submission experience required. Leadership and mentoring skills.
    • Demonstrated ability to lead the development, review, and approval of all clinical regulatory document types and the ability to develop new or unique document types.
    • Demonstrated ability to analytically evaluate and interpret clinical and scientific data; ability to define data presentation to meet key messages developed by the clinical and therapeutic teams.
    • Excellent project management skills including in-depth understanding of clinical timelines (study and submission level), working knowledge of the roles of other functional areas and interdependencies among groups; demonstrated ability to establish detailed timelines for completion of assigned projects and ensure efficient, timely completion.
    • Minimum 5 years of experience managing writing activities for major US, EU and/or other ROW international regulatory submissions (project and people management, management of overall resources).-
    • Expertise in global eCTD submissions required; phase 1-4 experience required; demonstrated excellence in leading global eCTD submissions, matrix leadership skills and strategic problem-solving ability.
    • Demonstrated ability to appropriately manage resourcing across multiple projects with competing workload priorities. Strong oral and written communication skills.
    • Working knowledge of current global regulatory requirements/guidelines applicable to clinical research and GCP/ICH/eCTD compliant documents; experience with interpreting and applying global regulatory authorities regulations and/or guidance, including but not limited to: ICH E3 (CSRs), ICH E6 (IBs), ICH M4, ICH E2E.Takeda U.S. Vaccine Requirement:Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.This job posting exclude Colorado applicants.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 ProgramsEmpowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.*RM-LIEEO 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

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