Seattle Genetics

Sr. Medical Writer

Description

Seattle Genetics is an emerging global multi-product biotechnology company that develops and commercializes innovative antibody-based therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to one marketed product, we are advancing a strong product pipeline of novel therapies for solid tumors and blood-related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients.

Summary

The Senior Medical Writer will be responsible for authoring and revising clinical and regulatory documents for submission to the FDA and other agencies, and to support other clinical communication efforts including abstracts and presentations for medical congress meetings and manuscripts for publication peer-reviewed journals.

Responsibilities:

• Minimum of 2 years (MS/PhD) or 5 years with (BA/BS) medical writing experience in the biopharmaceutical industry.
• Experience preparing clinical regulatory documents and scientific publications is crucial.
• Must have a solid understanding of FDA/ICH guidelines and GCPs.
• The ability to interpret statistical and clinical data.
• Prior NDA/BLA/MAA submission experience, including eCTD, preferred.
• Familiarity with clinical trial transparency requirements, including ClinicalTrials.gov and EudraCT standards, preferred.
• Must have strong written and verbal communication skills, and expert abilities in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat preferred.
• Must have the ability to coordinate and prioritize multiple projects in a fast-paced environment with little supervision.
• Background in oncology drug development is a plus.

Qualifications:

• Minimum of 2 years (MS/PhD) or 5 years with (BA/BS) medical writing experience in the biopharmaceutical industry.
• Experience preparing clinical regulatory documents and scientific publications is crucial.
• Must have a solid understanding of FDA/ICH guidelines and GCPs.
• The ability to interpret statistical and clinical data.
• Prior NDA/BLA/MAA submission experience, including eCTD, preferred.
• Familiarity with clinical trial transparency requirements, including ClinicalTrials.gov and EudraCT standards, preferred.
• Must have strong written and verbal communication skills, and expert abilities in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat preferred.
• Must have the ability to coordinate and prioritize multiple projects in a fast-paced environment with little supervision.
• Background in oncology drug development is a plus.

Education:

• Bachelor’s degree or higher, life sciences preferred.

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, color, religion, sex, national origin, protected veteran status, or disability status.

Apply:

Seattle Genetics

Seattle Genetics is an Equal Opportunity Employer

Submitted: 11/02/2018