Contract - SOP Writer

Location
94080, South San Francisco
Posted
Jul 09, 2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract

CONTRACT – SOP WRITER

Job Summary:

The SOP (Standard Operation Procedure) Writer will work with GBT’s Subject Matter Experts (SMEs) to prepare new or changes to existing SOPs, policies and work instructions as part of an overall document coordination and integration initiative in Clinical Development. This role will implement the document workflow process as a formal written procedure as well as being responsible for supporting the development and revision of procedures by applying document standards, criteria and adhering to timelines as well as incorporating latest regulations such as ICH E6 R2. The writer will focus processes on procedures specific to Drug Safety/Pharmacovigilance, Biostatistics/Data Management and Clinical Science. This is a contract position.

Essential Duties and Responsibilities:

  • Develop GCP SOPs and Work Instructions and ensure alignment with current GCP and ICH (E6 R2) guidelines
  • Support the full procedural document lifecycle for Policies, SOPs, Work Instructions (WIs) and Forms by serving as a SOP Writer
  • Collect input from stakeholders and consolidates comments, resolving conflicts collaboratively
  • Work with process owner and SMEs to implement agreed upon procedural development applying appropriate document standards and criteria, ensuring terminology consistency across documents
  • Translate process maps or other process representations and applies them to SOP procedures wording
  • Work with functional area SMEs to develop cross-functional process models
  • Contribute to the development and maintenance of up-to-date SOP Writer procedures so that the process is used and consistently applied by all SOP Writers
  • Display the ability to manage customer expectations
  • Demonstrate proactive thinking and actions
  • Familiar with cross-functional customer service techniques
  • Ability to multi-task in a fast-moving environment
  • Common SOPs the Writer is familiar with, and may work on processes such as: Implementation of Single Patient INDs and Expanded Access, Data Safety Monitoring Board, Adverse Event Reporting, Investigator’s Brochure, Protocol Development (and Amendments), Clinical Study Report, Clinical Trial Unblinding (End of Study)

Qualifications:

  • Bachelor degree in a scientific or life science field
  • At least 5 to 10 years of research and development SOP writing experience in the Biotech, Pharmaceutical, or Medical Device Industry, or relevant comparable background in Clinical Research is preferred
  • 10 to 15 years of R&D experience is required
  • Experience working in a GXP environment with emphasis on GCP, GLP, GPV, and GMP
  • Technical writing certification a plus
  • QA and Training experience a plus