Regulatory Affairs Specialist

This role supports the medical legal regulatory (MLR) submissions and artwork production teams. Each tactical element of artwork will require a full examination by this role. This person consults with project management, the production specialist creating the adaptation, and other stakeholders to ensure that the claims and references are accurate and compliant, and that each piece has been created and uploaded as required by brand, and MLR/PAAB file standards.

Must have experience and indicated on resume with MLR submissions, PAAB and Veeva PromoMats submissions

JOB QUALIFICATIONS

• Bachelor's degree in the life sciences or equivalent experience is required. Graduate degree in the life sciences preferred.

• Medical, pharmaceutical, or Life Sciences marketing experience preferred

• Experience in the delivery and management of complex quality assurance solutions

• Excellence client facing and customer service skills

• Knowledge of medical/pharmaceutical terminology, and federal regulations governing pharmaceutical advertising preferred

• Minimum 2 years of experience in MLR submissions and PAAB submissions required

• Ability to accurately review complex materials including multimedia graphics, texts, and web sites with excellent attention to detail

• Operates effectively in a fast-paced, deadline-driven environment; highly organized and multitasks effectively

• Excellent team player with strong interpersonal skills; ability to communicate effectively and work well with others

• Working knowledge of Microsoft Office, Adobe Acrobat and Veeva Vault PromoMats required

• Ad agency experience preferred

JOB DUTIES

(* denotes an “essential function”)

• * Checks quality and accuracy of annotations, tags/links, reference binders/packs, and edits to all advertising, promotional, and non-promotional communication materials to ensure accuracy of text, layout, organization and references; compliance with AMA or AP guidelines; and overall sense, consistency, and clarity

• * Work closely with Production team & other stake holders to ensure that jobs are compliant to brand, style, and file standards

• * Keep submission schedule on track

• * Ensure completed job by the studio meets the exact file standards and brief provided, and completing the jobs as per the planned timelines

• Help Project Management and Production teams to ensure that all files coming in are of suitable quality and align with file and brand standards at the start

• Constant communication with MLR, Production, and Project Management teams