Job Openings | USDM Careers

GCP Technical Writer SME
Technical Writer
Lexington, MA

GCP Technical Writer
The resource should have a strong Clinical background to create the clinical SOPs for the client. Good writer. Good communicator. Will need to facilitate working and review sessions. Track progress and ensure deliverables are on time.

Job tasks:

Partner with business area leaders and stakeholders to write/rewrite a complete set of GCP procedures

Work with leadership and a project coordinator to define a roadmap to deliver all procedures within the time allowed

Be a trusted expert adviser and partner

Facilitate SOP working sessions of 3 to 4 SME Stakeholders to gather requirements and build consensus

Write and review GCP Procedures that reflect current best practices


Formal qualification in the sciences and recent experience in the bio pharmaceutical industry, preferably including biologics

Thorough knowledge of current good clinical practices (GCP) and the complete regulatory context

Good communicator

Technical writing (Clinical SOPs)

Technical reviewer

Outstanding attention to detail but still responsive to evolving priorities and deadlines

Work with business area owner, SMEs and project coordinator

Local. Onsite in Lexington MA


Would you like to apply to this job?

Apply Here

Previous MonthNext Month