Regulatory Medical Writer II

Location
Seattle, WA, United States
Posted
Mar 23, 2021
Ref
1783
Hotbed
BioForest
Required Education
Other
Position Type
Full time
Responsible for managing, writing, and editing regulatory, clinical and nonclinical documents for Omeros programs. The role will interface with multiple cross-functional teams including Regulatory, Clinical, Safety, Research, Commercial Marketing, Legal, and Medical and Scientific Communications as well as external partners, authors and Key Opinion Leaders (KOLs).

Good things are happening at Omeros!

Come join our Omeros Regulatory Affair & Quality Systems Team!

Who is Omeros?

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple phase 3 and phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. Omeros also has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros' proprietary G proteincoupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.

What are your job responsibilities?

  • Writing, editing, and facilitating the review of regulatory documents, study protocols, study reports, investigator's brochures, health authority briefing documents, clinical data summaries, technical reports, and other medical/regulatory documents
  • Formatting and editing review of key documents for adherence to Omeros Style Guide conventions as well as consistency across documents
  • Developing and managing document preparation timelines including QC, cross-functional review, and reconciliation of comments
  • Maintaining the Omeros Style Guide and providing training to Omeros employees
  • Assisting in the development and maintenance of templates and guidelines for the standardization of documents
  • Managing cross-functional review of documents and reconciling comments with the primary author
  • Providing writing support for ad hoc projects
  • Bachelor's or an advanced degree in a scientific or health-related field with a minimum of 2 to 5 years of experience or equivalent in medical/regulatory/publication writing in the pharmaceutical, biotech, research, medical affairs, or CRO industries
  • Requires experience preparing regulatory documents for all types of submissions in electronic Common Technical Document (eCTD) format
  • Must have a solid understanding of FDA/ICH guidelines and GCPs. Familiarity with GLPs and GMPs desired
  • Must display strong analytical and problem-solving skills
  • Must have excellent writing and strong verbal communication skills
  • Must be adept at using a broad range of computer software to format and control large electronic documents
  • Expert abilities in Microsoft Word, Excel, and PowerPoint experience with scientific graphing applications preferred.
  • Must have the ability to build and maintain positive relationships with management, peers, and subordinates.
  • Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 20 lbs.
  • May encounter prolonged periods of sitting
If you have the experience, skills and knowledge we are seeking, we'd love to hear from you! This is an exciting opportunity for the right person!

Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes.

It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can either send an e-mail to hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000