Only candidates based in the US will be considered.

Summary:

The Sr. Technical Writer (Scientific writing) is responsible for producing high-quality documentation and for the technical formatting of complex documents. The position supports the necessary compliance activities associated with the Document Control department and the Quality Management System. This includes leading the periodic review process, external standards process, CAPA, nonconformance process and training. In addition to the above tasks, the Sr. Technical Writer is required to interact with multiple departments within the Cerus organization and prioritize tasks to timely completion.

Primary Responsibilities:

• Serve as the subject matter expert for scientific writing and the technical formatting of complex documents. This includes protocols, reports, GLP and non- GLP studies, specifications, and documents associated with filings and dossiers.

• Serve as the system administrator for the Cerus electronic document management system.
• Maintain and support the document control system for the release, approval, distribution, and obsolescence of quality system documents.
• Work closely with SMEs and/or authors throughout the document development process. Perform document draft reviews, formatting reviews, obtain feedback and provide guidance to ensure that documentation meets project requirements and deadlines.
• Format and edit complex documents using MS Word.
• Develop and maintain documentation standards, templates, and style guide to ensure consistency and alignment with industry best practices.
• Provide training/support to cross functional groups related to technical writing, technical formatting, and the use of MS Word.
• Lead the periodic review process and report progress with Key Process Indicators (KPIs), external standards process, CAPA and NC processes and training.
• Actively contribute to development of processes and procedures to improve departmental and cross functional workflows.
• Build relationships and work collaboratively with team members.
  
  

Education & Experience

• Bachelor of Science required.
• Seven years of experience with advanced scientific writing and technical formatting.
• Seven yearsof experience with electronic document management systems (EDMS) to complete workflow of document to final approval.
• Strong knowledge of quality systems ISO 13485, 21 CFR 820, MDSAP, MDR, ICH/GCP
• Expert knowledge using MS Suite programs, (Word, Excel, PowerPoint) and Adobe Pro DC to produce high quality documents.
• Experience with EDMS system implementation and validation is desired.
• Attention to detail related to consistency, grammar, syntax, and scientific accuracy.
• Excellent time management, ability to multi-task with a commitment to complete, and timely work is required.
• Ability to work with minimal or no supervision.

We understand that our people are essential to our success. This philosophy is revealed in our competitive benefits package, designed to improve employees' lives both on and off the job.

Benefits plans: medical, dental, vision, domestic partner benefits, paid maternity and paternity leaves, healthcare and dependent care flexible spending, life and accidental death insurance, long-term and short-term disability insurance, matching 401(k), ESPP, RSUs

Work and family: EAP, legal and financial services, health club membership discounts, tuition reimbursement

Compensation: The base salary range for this position if candidate is based in San Francisco Bay Area is $112,000-$137,000 annually.Compensation may vary outside of this range depending on various factors, including a candidate's qualifications, skills, competencies, experience, and location. Base pay is one part of the total package to compensate and recognize employees for their work.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.