Regulatory Medical Writer II

Location
Seattle
Posted
Oct 28, 2020
Ref
1783
Hotbed
BioForest
Required Education
Bachelors Degree
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?

True innovation requires the right people, and that's what we have at Omeros - smart, hard-working and creative individuals who collaborate and drive to achieve what has not yet been done. We see strength in diversity - diversity in thought, expertise and experience.

We have taken a similar approach in structuring our company. While many bio-techs pursue a single therapeutic area or scientific platform, we are strategically building a deep and diverse pipeline of first-in-class small-molecule and antibody therapeutics. The strength of our scientific discoveries and exclusive intellectual property positions enable our pipeline programs to target highly promising receptors and enzymes that others have not been able to develop.

Although cutting across a wide and diverse range of disorders and therapeutic indications - some orphan, others large-market and many for which there are no approved treatments - all of our drugs on the market and in development target critical unmet needs to improve the lives of patients in meaningful ways.

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