Regulatory Operations Specialist

Brace your career – you’re going beyond the science quo with Spectrum. We’re the full-service, health and science communications and media agency that’s out of this world. We’re fiercely independent and 100% science-focused so we can go where other “science-light” agencies can’t or won’t. Together with superhuman strategy, atomic creative, intermedia magic, interwoven ingenuity and indomitable innovation we dream beyond the realm of the possible – and do it.

The Regulatory Operations Specialist will manage project submissions for the assigned brands to obtain client’s medical, legal, and regulatory internal approvals. This person will also serve as an experienced regulatory operational resource for the other department members. 

Job Responsibilities

• Own IRB/EC submission process, partnering with account team to ensure all materials are finalized prior to submission
• Reviewing final packages pulled together by study teams, evaluating for completeness and accuracy of submitted study documents and required documentation using our team developed checklists to ensure compliance with client policies and procedures and Good Clinical Practices
• Submitting final packages to client and documenting submissions accordingly
• Ensuring all IRB/EC decisions are documented and tracked in internal system; following up with client/CROs as needed to obtain final documents
• Working with project management team to ensure deadlines and timelines are met
• Conducting regular follow-up with CROs on all outstanding submissions; coordinating any materials updates as needed; leading resubmission process

Desired Skills and Qualifications

• Excellent organizational and verbal communication skills to ensure accuracy and efficiency
• Able to think critically and be tech savvy; having the ability to master new systems as well as become the submissions expert for the assigned brands and have a good working knowledge of systems and processes across all brands
• Understand fact checks and reference annotations
• Prior writing experience required with a high-level understanding of the language used for annotating, tagging, and linking for submissions process
• Strong organizational skills, attention to detail and ability to manage multiple projects simultaneously
• High level understanding of with IRB submissions and clinical trial recruitment process highly desirable
• 1-2 years of experience, with agency experience highly desirable

The anticipated salary range for this position will be $50K-70K. Salary is based on job-related factors such as: years of relevant experience, qualifications and/or certifications. Spectrum reserves the right to modify this pay range at any given time.

You choose where you work. We are a hybrid work environment with options to work in one of our four offices (DC, NYC, Chicago, and Atlanta), remotely anywhere in the United States, or a combination that best suits your most productive work environment. 

Spectrum is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.