Scientific Writer II (contract 12 months plus)

Highly Competitive Salary
  1. Contract
  2. Medical Writing
  3. United States
Cambridge, Massachusetts
Posting date: 02 Aug 2019

Proclinical is currently seeking a Scientific Writer II for a biotechnology company located either remotely or in their Cambridge, MA office. Successful candidate will interact with other medical writers, document managers, document quality reviewers, and cross-functional teams, in order to create/author/manage documentation required to support clinical trials and regulatory submissions.

Job Responsibilities:

  • Independently prepare moderately complex clinical documents for one or more programs.
  • Coordinate preparation of clinical documents by other writers with minimal supervision.
  • Represent department on clinical teams.
  • Lead document-related meetings.
  • Review statistical analysis plans and clinical data reports as needed.
  • Mentor junior writers on departmental processes related to document preparation.
  • Review documents written by junior writers for content and format.
  • Participate on departmental initiatives.

Skills and Requirements:

  • MA/MS required PhD preferred.
  • 5+ years' regulatory writing experience with MA/MS, 4+ years' regulatory writing experience with PhD.
  • 1 or 2 and a half years of years or Reg writing experience.
  • Solid understanding of therapeutic area(s). Ability to interpret data.
  • Strong written and oral communication skills.
  • Flexible with exp level.
  • Strong organizational and meeting skills.
  • Therapeutic area working on will be neuroscience but need not have this specific therapeutic experience.
  • Solid understanding of standard clinical document types. Understanding of internal and external guidelines related to document preparation.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call George Watson at (+1) 929-223-4385 or upload your resume on our website -

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.