Contract -Technical Writer / Investigator

Location
San Francisco, CA, United States
Posted
Jun 14, 2021
Ref
1036
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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