Senior Manager/Associate Director, Regulatory Affairs Advertising & Promotion

Location
Seattle
Posted
Sep 30, 2019
Ref
1677
Required Education
Bachelors Degree
Position Type
Full time
This position is primarily responsible for the compliant implementation of regulatory advertising and promotional activities for marketed products and those in late‑stage development. Additional responsibilities include review and drafting of various regulatory submissions as well as serving as a regulatory representative on one or more program teams. The candidate must have a sound understanding of, and direct experience with, regulatory advertising and promotional regulations and must understand overall regulatory affairs in drug development. In accordance with current regulations and department procedures, the candidate will be responsible for providing regulatory review and guidance to the promotional review committee (commercial, legal, medical, and regulatory) regarding advertising and promotional activities, will be responsible for maintaining operating procedures for the promotional review committee, and will oversee submissions of promotional and other materials to FDA and other regulatory agencies.

Good things are happening at Omeros!

Come join our Regulatory Affairs and Quality Systems Group!

Who is Omeros?

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system.

The company's drug product OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3% is marketed in the U.S. 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. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.

Omeros has multiple Phase 3 and Phase 2 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 diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.

What are your job responsibilities?

  • Provides regulatory insight and advice to commercial, medical, and legal cross-functional colleagues on content, strategy, and implementation of advertising and promotional activities for Omeros products (commercial and pre-launch)
  • Serves as chair of the Promotional Review Committee (PRC) and ensures compliant and timely review of promotional materials by PRC in accordance with company procedures and relevant regulations
  • Actively contributes to strategic discussions regarding advertising and promotional materials, pre-approval and launch activities, and new promotional campaigns for marketed products
  • Maintains current knowledge of regulations, guidance's, and precedents that impact pharmaceutical advertising and promotion and provides insight to cross-functional colleagues regarding applicability to Omeros activities
  • Works closely with the cross-functional team to ensure that promotional materials, including important safety information, are consistent with current product labeling (package insert)
  • Assists with review and drafting of regulatory submissions annual reports, as well as other periodic reports required by EMA and FDA (e.g., DSUR, PBRER)
  • Serves as regulatory representative on one or more program teams
  • Collaborates and communicates effectively cross-functionally and across all levels of management
  • Provides creative and compliant solutions regarding advertising and promotional activities that balance business considerations and risk assessments
  • Assists in creation of new or revision of existing department standard operating procedures as appropriate
  • Manages regulatory tasks within time frame and budget of approved project plans
  • Minimum of a BS degree in a relevant field and at least 6 years of related experience and/or training, or an equivalent combination of education and experience in regulatory affairs advertising and promotion
  • Working knowledge of drug development guidelines and FDA regulations
  • Direct experience in regulatory advertising and promotion for orphan products and for products with FDA accelerated approval a plus
  • Regulatory Affairs Certification (RAC) a major plus
  • Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines
  • Excellent oral and written communication skill
  • Strong computer application skills used in general office settings including word processing, spreadsheet, presentation software, and internet search engines
  • Creativity and strong analytical and problem-solving skills are essential
  • Good organizational and planning skills
  • Must represent Omeros in a professional manner
  • Demonstrated ability to identify issues and take appropriate actions
  • The ability to build and maintain professional relationships with management, peers, and subordinates
  • May be performing repetitive movements such as keypad typing or using a mouse
  • May climb, bend, reach, push, pull, balance, stoop, kneel, or crouch
  • On occasion must lift and/or move up to 25 pounds.
If you have the skills, knowledge and experience we are looking for, we'd love to hear from you!

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.