Sr. Manager, Regulatory Medical Writing - Seattle, WA | Biospace
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Sr. Manager, Regulatory Medical Writing

Omeros Corporation

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Location:
Seattle, WA
Posted Date:
8/14/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

As the Sr. Manager, Regulatory Medical Writing you’ll be responsible for the development, writing and editing of nonclinical reports, CMC information, clinical documents, regulatory agency meeting requests, briefing documents, and response documents as well as applications such as INDs and NDAs for our development programs.

Good things are happening at Omeros!
Come join our Regulatory Affairs Group!

Who is Omeros?
Omeros is a Seattle-based biopharmaceutical company committed to discovering, developing, and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system.
Part of its proprietary PharmacoSurgery® platform, the company's first drug product, OMIDRIA® (phenylephrine and ketorolac injection) 1%/0.3%, was broadly launched in the U.S. in April 2015. OMIDRIA is the first and only FDA-approved drug (1) for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain and (2) that contains an NSAID for intraocular use. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.
Omeros has clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington's disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a proprietary G protein-coupled receptor, or GPCR, platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development, and a platform used to generate antibodies.

What are your job responsibilities?
•   Primary author working cross-functionally for regulatory documents including but not limited to research reports, agency briefing documents, agency response documents, Module 2 overview and summary documents to be submitted to regulatory authorities such as the FDA, European Medicines Agency and Health Canada
•   Working closely with clinical and other cross-functional content owners, preparation of high-quality key documents such as Investigator’s Brochures, clinical protocols, technical reports, and other scientific documents that may be submitted to regulatory agencies
•   Ensuring that Omeros writing standards are met, anticipating and assessing the regulatory writing needs, responsible for hiring and managing contract writers as appropriate
•   Assisting in the development and maintenance of templates and guidelines for the standardization of documents
•   Maintaining the Omeros Style Guide and providing training to Omeros employees
•   Serving as the primary regulatory writing representative on project teams working closely with Nonclinical, Clinical, Regulatory, CMC, and vendors/partners
•   Managing cross-functional review of documents and reconciling comments with the primary author
•   Managing document preparation timelines, including QC, cross-functional review and reconciliation of comments
•   Providing writing support for ad hoc projects that may include preparation of abstracts, posters, or other materials for Medical Affairs

Requirements

What experience and education do you need?
You’ll need to have a Bachelor’s degree in a life sciences discipline (advanced degree is a plus) and 7-10 years of regulatory writing experience with a minimum of 5 years of biopharmaceutical industry experience
Additionally, we are seeking candidates with the following experience:
•   Experience preparing regulatory documents for all types of submissions in electronic Common Technical Document (eCTD) format

What skills does our ideal candidate have?
As our ideal candidate, you’ll need the follow skills and knowledge:
•   A solid understanding of FDA/ICH guidelines and GCPs is required along with a familiarity with GLPs and GMPs
•   Excellent writing and strong verbal communication skills
•   Adept at using a broad range of computer software to format and control large electronic documents
•   Expert abilities and experience in Microsoft Word, Excel and PowerPoint with scientific graphing applications preferred
•   Demonstrated ability to build and maintain positive relationships with management, peers, and subordinates
•   Ability to display strong analytical and problem-solving skills
•   Superior attention to detail


If you have the skills, knowledge and experience we are looking for, we’d love to hear from you!
Apply at:  Omeros.com, About Omeros, Careers.  This will route you to our online applicant tracking system where you can apply.

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.