Seattle Genetics

Senior QA Associate Technical Writing

Description

Seattle Genetics is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in people’s lives. ADCETRIS® (brentuximab vedotin) uses the company’s industry-leading antibody-drug conjugate (ADC) technology and is approved for the treatment of multiple CD30-expressing lymphomas.

Beyond ADCETRIS®, the company has established a pipeline of novel targeted therapies at various stages of clinical testing, including three in ongoing or planned pivotal trials for solid tumors. Enfortumab vedotin for metastatic urothelial cancer and tisotumab vedotin for metastatic cervical cancer use our proprietary ADC technology. Tucatinib, a small molecule tyrosine kinase inhibitor, is in a pivotal trial for HER2-positive metastatic breast cancer. In addition, we are leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents in clinical trials targeting hematologic malignancies and solid tumors.

Summary

The Sr. QA Associate, Technical Writing will be responsible for the creation, revision and management of GMP documents including Policies, Procedures, and Work Instructions to achieve and maintain compliance with applicable regulatory requirements. The position will participate in the development and maintenance of the company’s global document hierarchy and will act as a consultant to other GMP functions in the development and revision of compliance related documentation.

Responsibilities:

• Plan, develop, organize, write, and edit polices, operational, procedures, work instructions, and GMP compliance related documents.
• Analyze documents to maintain continuity of style and content.
• Organize, conduct, and lead GMP cross functional meetings focused on development and revision of applicable documents.
• Act as an advisor to GMP staff during the revision of department specific GMP documents.
• Under limited supervision, may coordinate or lead the activities of multiple contributors to GMP writing projects.
• Lead and/or participate in the development or revision to the document writing process and document hierarchy infrastructure.
• May coordinate the activity of contract technical writers, and other providers.
• Develops and implements templates, style standards, and standard operating procedures to ensure consistent and high quality deliverables.

Qualifications:

• Minimum 6 years proven experience working as a technical writer.
• Minimum of 5 years of pharmaceutical experience working in current Good Manufacturing Practices.
• Excellent written and verbal communication skills.
• Proficiency in MS Office.
• Strong attention to detail.
• Able to write in explanatory and procedural styles for multiple audiences.
• Able to prioritize and multi-task.

Education:

• Bachelor’s degree in a life sciences or related field with pharmaceutical experience in current Good Manufacturing Practices.

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

Apply:

Seattle Genetics

Seattle Genetics is an Equal Opportunity Employer

Submitted: 11/29/2019