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 Senior Scientific Writer - Non-Clinical in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Scientific Writer - Non-Clinical working on the DMPK team, you will be empowered to write and edit nonclinical reports and summary document sections and identify which data are critical to a submission, and a typical day will include:
- Independently edit and write nonclinical reports and summary document sections. 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 resourceallocation and planning.
Act as project lead for nonclinical 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 editors, 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.
- Works independently to resolve issues and inform manager of resolution.
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelors degree with 6+ years pharma or related experience.
- Experience with drug development and regulatory submissions is preferred.
- Experience with writing Module Two or Module Four is preferred.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
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.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.