Contract - Development Operational Excellence Senior Technical Writer

Location
South San Francisco, CA
Posted
May 01, 2022
Ref
4429275004
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract

CONTRACT - DEVELOPMENT OPERATIONAL EXCELLENCE SENIOR TECHNICAL WRITER

Position Summary:

The Development Operational Excellence Senior Technical Writer is a highly skilled individual with life science industry experience.  OpEx Senior Technical Writers communicate complex information clearly, concisely, and accurately, without relying on jargon.  In this role, you will serve as a liaison working with Development and Quality to drive strategic compliance priorities in support of Operational Excellence Management.  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 through the application of knowledge management
  • Work with Subject Matter Experts to prepare new documents or changes to existing Policies, SOPs, and Work Instructions
  • Author/Update new process documents or changes to existing process documents
  • Calibrates with the business and management to determine revisions to governance documents
  • Creates and Translates process maps or other business representations to apply to SOP writing
  • 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 Business Reviews.  Highlight opportunities to drive improvements in Development across all functions
  • Collaborate with internal teams to develop training, onboarding, content and focused coaching based on industry trends
  • Aid in establishing electronic systems for document workflows, when required

Qualifications:

  • Bachelor's degree in a scientific-related field or equivalent experience and 5-8 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 Smartsheets and MS office products, particularly, 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
  • Demonstrated experience building relationships with peers and senior stakeholders and collaborating with cross-functional teams across multiple locations
  • Track record of operating independently and delivering results, embracing ambiguity, demonstrating creativity, and delivering results in a highly organized manner
  • Experience thinking analytically and strategically about issues and influencing stakeholders, leadership and individual contributors at all levels
  • Lean / Six Sigma experience is 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 contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity

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.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company’s facilities.  The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.