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Manager, Regulatory Affairs, Promotions & Advertising

Employer
Omeros Corporation
Location
Seattle, WA
Start date
Sep 13, 2022

View more

Discipline
Marketing, Advertising, Regulatory
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioForest
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Job Details

Manager Regulatory Affairs, Advertising and Promotion

 

 

Good things are happening at Omeros!

 

Come join our Regulatory & Quality Systems Team!

 

 

 

The Manager of Regulatory Affairs, Advertising and Promotion reports to the Director, who is responsible for the Commercial Regulatory function. As a Manager, you are accountable for all operational aspects of Regulatory Advertising/Promotion providing planning and technical support for the Company’s products.

 

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.

 

Job Responsibilities:

 

  • Responsible for running the process including facilitation of review and tracking of all materials throughout the review and approval process in collaboration with Commercial Operations and closely interacting with relevant departments, teams and agencies
  • Manage proofing for print and digital production materials within the scientific principles of regulatory/quality reviews
  • Submission activities for pre-clearance and 2253, "time of first use" submissions and also regulatory activities involved with a new product launch
  • Providing strategic regulatory advice on advertising and promotional materials and activities in accordance with business goals and objectives, FDA regulations/guidelines, PhRMA guidelines, and company policy
  • Serve as regulatory submissions liaison to FDA/CDER/OPDP for assigned products, as a single point of contact for the compilation, submission, tracking, approvals and review of Form 2253 to transfers for FDA’s Office of Prescription Drug Promotion submission
  • Check data sources supporting Advertising and Promotional materials and labeling claims, history of labeling negotiations and changes
  • Manage proofing of print and digital materials for production
  • Supports goals and prioritize workload with Commercial Operations, reflecting clear alignment with the Commercial organization’s strategic priorities
  • Establishes collaborative relationships with the Commercial Operations/Marketing team and agencies through frequent communication and interaction to understand needs and optimize effectiveness
  • Provide notification of FDA submission of materials to project originators and maintain Activity Tracker for FDA-OPDP submissions
  • Ensures the appropriate and timely review and approval of any generated materials in accordance with relevant SOPs and local laws/codes of practice
  • Candidate to assist with additional regulatory projects as needed

 

Education, Experience, Skills, and Knowledge Required:

 

  • Bachelor’s degree required, higher degree with clinical and scientific training will be an advantage (MS, PharmD, PhD, RN)
  • 5 years of experience in Regulatory Affairs Advertising & Promotion (desirable)
  • Experience in leading activities for pre-clearance and 2253, "time of first use" submissions (desirable)
  • Experience with regulatory activities involved with a product launch (desirable)
  • Strong ability to work with cross-functional teams
  • Strong project management skills with the ability to collaborate and manage with all stakeholders to adhere to timelines and deadlines; work independently on assigned projects within timelines
  • Great attention to detail and ability to interpret clinical and scientific data is required
  • Ability to work in a fast-paced, cohesive, collaborative team-oriented work environment

 

Behavioral Competencies Required: 

 

  • Demonstrated ability to build and maintain positive relationships with management, peers, and subordinates
  • Integrity

 

Physical Demands Required

 

  • May encounter prolonged periods of sitting or standing

 

 

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.

 

Company

At Omeros, we are proud of our innovative and cutting-edge science. Our world-class team has achieved scientific advances that no other group has been able to accomplish, delivering wholly new classes of therapeutics to benefit patients. We let science lead the way.

From our foundation of groundbreaking science, we continue to build and advance a deep and diverse pipeline of small-molecule and protein therapeutics. We are not interested in developing “me-too” products; instead, we are focused on tackling challenging diseases and disorders with significant unmet medical needs. The result is an exciting pipeline of first-in-class drugs with new mechanisms of action that target previously untapped receptors and enzymes.

The Omeros team is exceptionally talented, passionate, collaborative and diverse. We hire smart, creative and hard-working people who want to play a meaningful part in building a preeminent biopharmaceutical company. We come from all corners of the globe, bringing unique abilities and experiences together to provide hope to patients and their families.

Find Us
Phone
206.676.5000
Location
201 Elliott Avenue West
Seattle
98119
US
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