Contract -Technical Writer / Investigator

Company: Global Blood Therapeutics, Inc.
Location: South San Francisco
Posted on: June 10, 2021

Job Description:

CONTRACT - TECHNICAL WRITER / INVESTIGATOR

Position Summary:

The Technical Writer / Investigator is a highly-skilled individual with life science industry experience. Technical writers communicate complex information clearly, concisely and accurately, without relying on jargon. In this role, you will serve as a liaison working with Quality and Clinical Operations to drive strategic compliance priorities. This role reports to the Director of Clinical Operations Excellence

Essential Duties and Responsibilities:

* Develop a deep understanding of the company's policies, data, operational structure, and products to identify ways to enhance GxP compliance * Work with Subject Matter Experts to prepare new documents or changes to existing Policies, SOPs, and Work Instructions * Aid in establishing electronic systems for Investigations and Change Control * Calibrates with the business and management to determine revisions on quality procedures and standards * Creates and Translates process maps or other business representations to apply to SOP writing * Maintain ongoing awareness of industry and organization-wide best practices for quality and share information across the board as necessary * Support efforts to understand requirements, for any new regulations, conduct gap analyses of system, processes, and supporting documentation, outline impact, define changes required, and support implementation to verify compliance * Regularly analyze and report trends to support QMRs. Highlight opportunities to drive improvements in Quality across all functions * Collaborate with internal teams to develop training, onboarding, content and focused coaching based on industry trends

Qualifications:

* Bachelor's degree in a scientific-related field or equivalent experience and 8-10 years' experience in the life sciences industry * High level of professionalism and collaboration in team settings * Focus on compliance, driving results, and upstream thinking * Ability to quickly ramp up knowledge of business and quality management systems * Fluency with MS office products, in particular, MS Word * Organized, detail-oriented, able to perform tasks methodically, and can employ critical thinking in problem-solving * Ability to manage multiple simultaneous projects with attention to detail and delivery dates * Able to escalate risk with the necessary urgency * Strong interpersonal skills with the ability to clearly communicate in writing and verbally * Lean / Six Sigma experience is a plus

Keywords: Global Blood Therapeutics, Inc., South San Francisco , Contract -Technical Writer / Investigator, Other , South San Francisco, California