Senior Specialist, Regulatory Operations

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 Senior Specialist, Regulatory Operations will manage all 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. This role reports to the Director of Operations.

Job Responsibilities

• Upload clean, properly named documents, and annotate pieces with appropriate references based on copywriters’ provided documents (linking and tagging)
• Submit tactics to MLR portals for various brands, using numerous systems (oMAP, PROGRES, Veeva PromoMats, Aprimo, etc.)
• Act as a subject matter expert on the submission systems and process for assigned brands
• Identify information required for submission of tactics (eg, intended for use, page numbers) with input from account team as needed
• Responsible for resubmissions, final submissions, validation, functional annotations, etc., as specified by assigned brands regulatory process needs
• Upload relevant supporting documents to accompany submissions
• Link tactics to relevant component assets as per assigned brands regulatory process
• Track status of submitted tactics in the MLR portal
• Create tags within appropriate references associated with each piece
• Partner with copy team to ensure all annotations are completed
• Organize or attend meetings related to the submissions/review process as necessary
• Pull reports and comments from regulatory reviews
• Develop an understanding of the submission days/deadlines across assigned brands
• Ensure the PMO for the assigned brands have scheduled submission dates onto the full Reg Ops submission calendar
• Partner with account team of assigned brands to ensure all submissions are completed
• Clearly and professionally communicate with the internal teams and submissions coordinators regarding submissions and timing
• Inform the team of updates to the MLR process of assigned brands
• Keep an updated record of all best practices and training materials for the assigned brands

Desired Skills and Qualifications

• Minimum 4 years’ experience in client submissions
• Excellent organizational, written, 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 familiarity of the language used for annotating, tagging, and linking for submissions process
• Strong organizational skills and ability to manage multiple projects simultaneously
• It is expected that the Senior Regulatory Operations Specialist will complete training and obtain a Veeva PromoMats Certification while in this role
• Highly organized with a strong attention to detail

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.

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.