Associate Director/Director Regulatory Medical Writing

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Job description

Associate Director/Director, Regulatory Medical Writing

Position Summary:

Responsible for authoring, managing, and editing clinical regulatory documents (e.g., CSR, protocols, IBs), periodic safety reports, 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. Support development of regulatory briefing documents and regulatory response documents. Additionally, oversee outsourced writing performed by vendors and/or contract medical writers.

Good things are happening at Omeros!

Come join our Omeros Medical Affairs Team!

Who is Omeros?

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 .

Essential Duties & 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, Knowledge, and Skills Required:

• Bachelor's degree and a minimum of 7 years as a regulatory writer in the biopharmaceutical industry
• 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
• 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 documents

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

Flexibility and ability to assimilate corporate business priorities and needs

Compensation and Benefits

Omeros is proud to offer a competitive total compensation package designed to support the lives of our employees and their families. The wage scale for the Associate Director/Director, Regulatory Medical Writing role is $170,000 - $240,000. Salaries will be determined based on knowledge, skills, education, and experience relevant to the role. Employees are offered medical, dental, vision, life insurance, and a 401(k) plan with a company match. Employees accrue three weeks of vacation and 80 hours of sick time on an annual basis and receive twelve paid holidays throughout the calendar year. This position is eligible for bonus and stock options. To learn more about Omeros, please visit .

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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 or contact Omeros, asking for Human Resources, at .

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