Director, Regulatory Medical Writing

Associate Director/Director, Regulatory Medical Writing

As the Director, Regulatory Medical Writing, you will be responsible to author, manage and edit clinical regulatory documents (e.g., CSR, protocols, IBs), regulatory agency briefing documents and response documents, clinical submission documents for marketing applications (BLA, NDA, MAA, NDS), and investigational applications (IND, CTA) for our development programs, providing regulatory-compliant documents with consistent messaging and use of program-specific technical terms resulting in well written, reader-friendly documents and applications. You will additionally oversee outsourced writing performed by vendors and/or contract medical writers.

Good things are happening at Omeros!

Come join our Omeros Regulatory Affairs Team!

About Omeros Corporation

Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases) and cancers. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial. For more information about Omeros and its programs, visit www.omeros.com.

What are your job responsibilities?

·       Work closely with clinical and other cross-functional content owners to author, manage, and/or drive the development of high-quality clinical documents, such as investigator’s brochures, clinical protocols, clinical study reports, agency briefing documents, agency response documents, and/or Module 2 overview and summary documents that will be submitted to regulatory authorities such as the FDA, European Medicines Agency, and Health Canada

·       Coordinate medical writing resources performed by contract medical writers and/or vendors, including the planning, development, management of cross-functional reviews, reconciling comments with the primary author, editing, QC, and formatting of clinical documents in alignment with Omeros styles

·       Assist in the development and maintenance of templates and guidelines for the standardization of documents

·       Assist in the maintenance of the Omeros Style Guide and provide training to Omeros employees

·       Manage document preparation in accordance with established timelines, including writing, editing, QC, cross-functional review, eCTD readiness for pre-publishing, and final hand-off to document management

·       Provide direct writing support for ad hoc projects that may include preparation of abstracts, posters, or other materials for physicians and Medical Affairs

Education, Experience, Skills, and Knowledge Required:

• Bachelor’s degree and a minimum of 8 years of experience as a regulatory writer in the biopharmaceutical industry (a minimum of 10 years for a Director role)
• Depth of experience preparing regulatory documents for all types of submissions in electronic Common Technical Document (eCTD) format
• Excellent organizational and/or project management skills
• Depth of experience and enthusiasm for successfully overseeing the work of outsourced contract writers and vendors
• Solid understanding of FDA/ICH guidelines and GCPs, with a familiarity with GLPs and GMPs
• Excellent technical/regulatory writing skills and strong verbal communication skills
• Expert abilities in Microsoft Office Professional, Adobe Acrobat, and experience with scientific graphing applications
• Adept at version control, formatting, and managing large electronic document

Behavioral Competencies Required: 

• Demonstrated ability to build and maintain positive relationships with management, peers, and subordinates
• Enthusiasm for adapting and learning new skills and helping others to learn and adapt to situations as they evolve
• Strong analytical and problem-solving skills
• Superior attention to detail

Physical Demands Required: 

• Intermittent physical activity including bending, reaching, pushing, pulling or lifting up to 20 lbs.
• May encounter prolonged periods of sitting

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.