Senior QA Technical Writer

Job Description

As part of the Document Control Team in the Quality Assurance (QA) Department, the Senior Technical Writer works collaboratively with various Exelixis teams to produce and improve documentation for use in supporting various business processes. This includes, but is not limited to Policies, Standards, SOPs, Work Instructions, and Product Specifications.

A Senior QA Technical Writer understands both the business requirements and the technical details of the processes to be able to effectively produce high quality documentation. Adepts at translating verbal descriptions of processes into clear, well-written documents. Skilled at mapping processes that align with documents. Examines the processes to help derive information for documentation.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES: Author controlled documentation within the Exelixis documentation systemo Conduct review sessions with internal partners to provide comment and improvement recommendations.o Work closely with management and subject matter experts to determine content for documentation.o Organize material and complete writing assignments according to set standards regarding order, clarity, conciseness, style, and terminology.o Format for ease of use and clarity; including flowcharts.o Review documentation packages for accuracy to the company standard. Maintain templates for SOPs, Standards, Policies, Work Instructions, and Specifications. Support team improvement projects. Deliverables must be accurate and timely.

SUPERVISORY RESPONSIBILITIES: No supervisory responsibilities

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:Education: Bachelor’s degree in life sciences or communications and eight plus years of related experience; or Master’s degree in life sciences or communications and six plus years of related experience; or Equivalent combination of education and experience.

Experience: Experience in biotech, pharmaceutical or related industry. Six to eight years of technical writing experience. Demonstrated knowledge of GxPs, Health Authority Regulations, Quality Systems, and technical expertise in document management. Experienced with paper and Electronic Documentation Management System (EDMS). Familiarity with Veeva database software; strongly preferred.

Knowledge/Skills: Highly organized, detail oriented and works effectively as both a team member and independent contributor, with minimal oversight. Must be able to read, understand, speak, and write (print) legibly in English. Ability to communicate clearly and precisely, both orally and in writing, is essential. Strong knowledge and understanding of clinical and commercial processes and the Global Regulatory Requirements and regulations related to GxP. Must have strong critical thinking skills, initiative, integrity, and strong interpersonal and leadership skills. Demonstrated proficiency in MS Suite, particularly Microsoft (MS) Word, Excel, and PowerPoint, Visio equivalent, database manipulation and data extraction. Demonstrated ability to translate verbally conveyed processes into a standard document.

WORKING CONDITIONS: Environment: working indoors, office based Travel not required

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Additional Information

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.