Senior Medical Writer - Contract - Home Based USA

Highly Competitive Salary
  1. Contract
  2. Medical Writing
  3. United States
Boston, Massachusetts
Posting date: 14 Aug 2019

Proclinical is currently recruiting for a Senior Medical Writer for a biotechnology company located in Boston, MA but the position can also be remotely based for experienced candidates after a 1-week onsite orientation period.

Job Responsibilities:

  • 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.
  • 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.
    Participates on departmental initiatives Participate on cross-functional teams and influence decision making.
  • Lead strategy discussions related to document development.
  • Analyze and interpret strategic information with direction.
  • Anticipate problems with completing tasks and develop solutions with minimal direction.
  • Make decisions related to task prioritization with direction.
  • Provide information to management to facilitate decision making. Decisions affect primarily study and program activities.
  • Make recommendations for process improvements within department and participate in discussions to implement change.

Skills and Requirements:

  • MA/MS required PhD preferred in Life or Health Science discipline.
  • 5+ years of regulatory writing experience with MA/MS; 4+ years regulatory writing experience with PhD; 1 - 2 years of experience in Reg writing required.
  • Ability to receive direction on document review and team leadership skills.
  • Knowledgeable of internal and external guidelines related to content and format of clinical documents.
  • 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.