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Manager Nonclinical Writer/Editor

Boston, Massachusetts

Overview

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!

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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.

  • Collaborative
  • Strategic
  • Results Driven
  • Team Player
  • Versatile
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

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Manager Nonclinical Writer/Editor

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Job ID R0012019 Date posted 09/10/2019 Location Boston, Massachusetts

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda.  Join us as a Scientific Writer/Editor, Nonclinical in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Scientific Writer/Editor, Nonclinical working on the Nonclinical Writing and Documentation team, you will be empowered to successfully write and edit nonclinical reports and act a project lead, and a typical day will include: 

Position Summary:

  • Independently edit and write nonclinical DMPK, DSRE, and pharmacology reports and author nonclinical Module 2 documents. . Provide guidance to junior editors.
  • Write draft documents. Guidance may be needed when editing or writing more complex or unusual documents.
  • Independently assess gaps in submission documentation, on the basis of regulatory requirements (eg, ICH M4, S9 versus M3). Independently propose solutions to address gaps.
  • Identify which data are critical to a submission, and use these data (from source documents, such as study reports and articles) to generate summary documents. Present the data in the format best suited to the summary document (eg, create tables and draft new text as best suits a given set of data). Able to summarize data into succinct and informative text, without losing accuracy. Assist manager with resource allocation and planning.
  • Act as project lead for nonclinical writing on projects of moderate scope (eg, IND). With guidance, lead more complex projects (eg, MAA).
  • Review work of junior editors, and provide training when required, assisting with their professional development. Balance workload among a small group of writers, either to support own projects or to support the work of the group as a whole. May take on a supervisory role for editors, vendors, and contractors. May be responsible, with supervision, for performance management and development of employees (small number of individual contributors) with coach and counsel.
  • Independently to resolve issues and inform manager of resolution


Qualifications

  • Bachelors degree w/6+ years pharma or related experience or PhD with 1-2 years pharma or related experience. Experience with drug development, regulatory submissions, and MS/PhD preferred.
  • Takeda provides equal employment [and affirmative action] opportunities to minorities, females, veterans, and disabled individuals, as well as other protected groups.

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

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

#LI-SM1

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0012019

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