Senior Scientific Writer - Remote Based USA

Highly Competitive Salary
  1. Contract
  2. Medical Writing
  3. United States
Santa Fe, New Mexico
Posting date: 13 Aug 2019

Proclinical is currently seeking a Scientific Writer II, remotely based, for a leading biotechnology company. 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 (e.g., SMT, CDT); 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 - 2.5 years of Reg. writing experience preferred.
  • Experience in therapeutic area working on neuroscience.
  • Strong written and oral communication skills.
  • Strong organizational and meeting skills.
  • Solid understanding of therapeutic area(s). Ability to interpret data.
  • Solid understanding of standard clinical document types.
  • Solid 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.