Contract SOP Writer - Drug Developement
CONTRACT SOP WRITER – DRUG DEVELOPMENT
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 project in Clinical Research. 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. The writer will address procedures from Clinical Operations, Global Medical Affairs, Global Drug Safety, Global Regulatory Affairs, Research and Clinical Development Operations. This is a contract position, 20-30 hours a week, with 1-2 days a week in the office.
Essential Duties Responsibilities:
- Develop GCP SOPs and Work Instructions and ensure alignment with current GCP and ICH (E6 R2) guidelines
- Develop Clinical Operation on-boarding program, training program and revision of current JDs
- Supports the full procedural document lifecycle for Policies, SOPs, Work Instructions (WIs) and Forms by serving as a SOP Writer
- Collects input from stakeholders and consolidates comments, resolving conflicts collaboratively
- Works with process owner and SMEs to implement agreed upon procedural development applying appropriate document standards and criteria, ensuring terminology consistency across documents
- Translates process maps or other process representations and applies them to SOP procedures wording
- Works with functional area SMEs to develop cross-functional process models
- Contributes 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
- Contributes to the maintenance and updates to the SOP, coordinating tracking spreadsheets and timelines, as assigned
- Displays the ability to manage customer expectations
- Demonstrates 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:
GCP Training, Site Monitoring visits, Subject Screening and Recruitment, Informed Consent Process and Documentation, Eligibility Confirmation. Source Documentation, Data Management, Protocol Deviations, Adverse Events and Serious Adverse Events Reporting, Confidentiality of Information, Drug/Device Storage, Accountability and Management. Regulatory Document Submission Process (Initial Submissions, Amendments and Continuing Reviews), Sample Processing and Shipping Training, Monitoring Visits, Sponsor, CRO and Internal Audits.
- Bachelor degree in a scientific or life science field
- At least 5 to 10 years of research and development medical writing, or 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
Fit with GBT culture:
- Ability to build strong relationships with co-workers of various backgrounds and expertise
- Ability to function at a high level in a team setting whether leading the group or acting as an individual
- Values-based leadership consistent with GBT's Core Values
- Excitement about the vision and mission of GBT
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.