Scientific Editor, Randstad, Cambridge, MA

Posted October 6, 2014

Position Summary:

The position is working for Randstad on-site at Millennium: The Takeda Oncology Company.

The position is a 6-12 month contract position.

The Nonclinical Writing group is looking for a contract Scientific Editor to coordinate reviews and edit nonclinical documentation for regulatory submissions. Scientific Editors are critical to the success of the Nonclinical Writing group and are primarily responsible for editing nonclinical study reports and submission sections, as well as timeline management related to those documents.

Duties & Responsibilities:

This candidate will be responsible for:

• Independently editing nonclinical protocols, reports, and summary document sections.
• Providing ad hoc writing support for reports and written and tabulated summary sections.
• Creating content-rich templates.
• Independently creating nonclinical tabulated summaries.
• Using their regulatory and editorial expertise to provide guidance to nonclinical project team members.

Duties:

• Edit nonclinical protocols, reports, and regulatory summary document (submission) sections (eg, INDs, IMPDs, Briefing Documents).
• Populate annual updates for regulatory agencies (eg, IND ARs, DSURs) from final reports and protocols.
• With guidance, coordinate the nonclinical components (timeline, reviews, revisions) on projects of moderate scope (eg, nonclinical sections of an IND).
• Represent the nonclinical function on cross-functional submission working group meetings.
• Develop, communicate, and ensure adherence to project timelines.

Qualifications:

• Bachelors Degree with 3+ years pharma or related experience.
• Experience with scientific editing/writing or publications preferred.

Years of Experience:

3-5 years

Contact:

Lauri Marsanne
Sr. Account Manager
On-site business partner of:
Millennium: The Takeda Oncology Company
40 Landsdowne Street
Cambridge, MA 02139
617.444.4360
[email protected]
[email protected]