Manager Nonclinical Writer/Editor
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.
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- Team Player
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Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.
Manager Nonclinical Writer/EditorApply Now
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:
- 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
- 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.
Job ID R0012019