Submission Lead/Senior Scientific Writer

Company: Takeda Pharmaceuticals International GmbH
Location: Cambridge
Posted on: February 16, 2021

Job Description:

The health and safety of our employees and candidates is very important to us. Due to the current situation related to the Coronavirus (COVID-19), we're leveraging our digital capabilities to ensure we can continue to recruit top talent at Takeda. As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey. If so, one of our colleagues will explain how these tools will be used during the recruitment process. Thank you. *Please be aware of an Identity Theft Scheme targeting individuals seeking jobs with Takeda and other employers. See below or here for more info. Submission Lead/Senior Scientific Writer - Remote Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda's long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole. As one of the world's leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units. We are a passionate team doing important work that impacts patients' lives. If you are driven to create better health and a brighter future, join us! Success What makes a successful member of our team? Check out the traits we're looking for and see if you have the right mix. Life at Takeda A Global Top Employer Recognized for our culture and way of working, we're one of only select companies to receive Top Global Employer -- status for 2021. Submission Lead/Senior Scientific Writer - Remote Job ID R0030132 Date posted 02/11/2021 Location Cambridge, Massachusetts 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 Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Submission Lead/Senior Scientific Writer Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Submission Lead/Senior Scientific Writer 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 Submission Lead/Senior Scientific Writer in the Nonclinical Regulatory Writing and Submissions (NRWS) group within Preclinical and Translational Sciences (PTS), you will be empowered to contribute to this collaborative and dynamic environment, bringing experience to add further value to the NRWS contribution to the PTS organization, with involvement in a variety of projects of diverse scope and complexity, reflecting the breadth of Takeda's portfolio. A typical day will include: POSITION OBJECTIVES:

• Responsible for the generation and management of nonclinical regulatory submission components for compounds in Takeda's Research and Development portfolio across all developmental stages (pre-development through post-marketing) and Takeda's major therapeutic areas (eg, Oncology, Gastrointestinal, Neuroscience, Rare Disease).
• Involved in a variety of projects of diverse scope and complexity, reflecting the of breadth of Takeda's portfolio. The NRWS team is a very goal- and customer-driven team, and the incumbent will contribute to this collaborative and dynamic environment, bringing experience to add further value to the NRWS contribution to the PTS organization,
• Represent NRWS on cross-functional teams, and will lead the nonclinical submission subteams, working in close partnership with Global Regulatory Affairs (GRA) and nonclinical subject matter experts (SMEs) from pharmacology, drug metabolism and pharmacokinetics (DMPK), drug safety research and evaluation (DSRE) functions and external collaborators. The Submission Lead/Senior Scientific Writer is responsible for the planning, management, authoring and delivery of high-quality nonclinical summary components to support all regulatory submissions globally in accordance with the regulatory strategy developed by GRA (eg IB, briefing books, IND/CTA, CAC-SPA, RMP, periodic reports, PIP, NDA/MAA/BLA).
• Provide nonclinical regulatory expertise and mentorship to members of NRWS. May lead or support training initiatives within the group and will support maintenance of a balanced workload among NRWS Submission Leads. May serve as the NRWS representative on cross-functional initiatives. POSITION ACCOUNTABILITIES:
  • Lead the planning, tracking, compilation and regulatory compliance of nonclinical documentation for regulatory submissions.
  • Representative on multiple project team across multiple therapeutic areas. For each assigned compound, manage all nonclinical content for global submissions.
  • Represent NRWS on cross-functional teams (Clinical, Global Patient Safety, Program Management, Global Regulatory Affairs, Regulatory Operations) to plan, generate, manage, and finalize nonclinical documents for regulatory submissions. Generates nonclinical timelines. Liaises effectively with cross-functional team members to communicate aims, content requirements, and timelines.
  • Interpret nonclinical data to independently author and/or edit nonclinical documents. Ensure alignment with ICH guidelines.
  • Work closely with SMEs from DSRE, DMPK, Drug Discovery units and Therapeutic Area units to ensure appropriate input, review, and finalization of regulatory submission documentation activities in alignment with NRWS and Takeda processes. EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
    • College degree B.S./M.S. preferably in scientific field (eg, biology, pharmacology, toxicology), and/or Regulatory field and/or related biomedical discipline. Bachelor's degree with 6+ years pharmaceutical or related experience or Master's/PhD with 3-4 years pharmaceutical or related experience.
    • Experience in pharmaceutical or biotech product development across numerous modalities, with direct involvement in regulated studies related to pharmacology, toxicology, or pharmacokinetics, demonstrating a broad understanding of the drug development process.--
    • Significant experience in direct authoring of nonclinical summary sections and other components to support regulatory submissions, including but not limited to IB, briefing books, IND, CAC-SPA, periodic reports, NDA/MAA/BLA/J-NDA, and agency responses.
    • Experience with regulatory submissions for new modalities (eg: cell therapies, gene therapies, biologics) an advantage
    • Experience in a program management-type role; ability to prioritize, manage multiple programs within strict regulatory/compliance deadlines and lead internal/external and scientific teams to Regulatory submission aims
    • Thorough understanding of regulatory guidelines related to global submissions and submission content (e.g. FDA/EMA/PMDA regulations; ICH guidance and familiarity with GLP/GCP requirements) 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 Check out where you could be
        working if you apply. Job Seekers: Protect yourself against identity theft Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers. Copyright 1995-2019 Takeda Pharmaceutical Company Limited. All rights reserved.

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