Skip to main content

This job has expired

Sr. Medical Writer

Employer
Seagen
Location
Bothell, Washington State
Salary
Market Rate
Closing date
Jun 30, 2019

View more

Position
Administrator/Manager
Category
Pharmaceutical, Biotechnology
Hours
Full Time
Education
BS
Career Fair Category
Career Fair

Job Details

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 in peer-reviewed journals.

 

 Responsibilities: 

  • Author, revise, and edit clinical study reports, clinical study protocols, investigator’s brochures, clinical data summaries, and other medical/regulatory documents
  • Develop and author abstracts and slides or posters presenting clinical study data to medical congresses and the development of primary manuscripts for publication in peer-reviewed journals
  • Represent medical writing on project and program teams through collaborative engagement with personnel from other clinical disciplines, regulatory affairs, and scientific departments
  • Develop and manage the overall document development process including timelines, document reviews, and approvals in adherence with company standard operating procedures and regulatory guidance
  • Contributes to clinical trial registry postings and results disclosures on US and EU platforms

 

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

 

 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.

Company

Seagen is a global biotechnology company that develops and commercializes transformative cancer therapies. We’re driven by a singular mission—to make a difference for people impacted by cancer.

As an industry leader in antibody–drug conjugate (ADC) technology, we pioneered the science of harnessing antibodies designed to deliver cell-killing agents to cancer cells. Three of our four approved medicines are built on this technology.

We also focus our research efforts on novel targeted small molecule therapies. In addition, we are leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents.

Company info
Website

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert