Regulatory Specialist

CG Life

6d • $55,000 - $70,000

About The Position

The Regulatory Specialist oversees, educates, and advises on the medical, legal, and regulatory (MLR) aspects of promotional material development. The Regulatory Specialist is responsible for ensuring the accuracy and integrity of all promotional content for our healthcare clients. This includes ensuring compliance with all applicable FDA regulations, client-specific requirements, and editorial guidelines. For all assigned projects, the Regulatory Specialist oversees all regulatory-related efforts, including submission preparation, incorporation of MLR feedback, and MLR approval, and is expected to adhere to and evangelize internal workflow processes. The Regulatory Specialist increases the knowledge of the Regulatory team to ensure compliance and maintain a high level of submission quality.

Requirements

• Bachelor’s degree in English, healthcare, communications or similar (Master’s preferred), or similarly relevant degree
• 2+ years experience in editing or writing for a technical audience (medical, science, engineering, etc)
• Proven ability to manage a large number of deliverables in a fast-paced environment
• Familiarity with scientific journal formats and comprehension of study methods and results
• Familiarity with the AMA Manual of Style, 11th ed
• Substantial working knowledge of Adobe Acrobat, Microsoft Office Suite, and Mac OS

Nice To Haves

• Background in health sciences
• Familiarity with regulatory or legal review processes in healthcare or other regulated industry

Responsibilities

• Gain a deep understanding of internal and client regulatory processes and requirements as well as FDA regulations and guidance, educate team members about them, and update internal documentation as processes or requirements change
• Become an MLR expert by identifying trends, risks, patterns, and precedents to inform our content creation and speed up the approval process, and work to increase the expertise of the Regulatory team by seeking and sharing knowledge
• Advise Project Management, Accounts, and Strategy team members on regulatory risk considerations and MLR submission strategy for current projects
• Contribute to developing and maintaining documentation on regulatory compliance, submission preparation processes, and client-specific MLR requirements
• Collaborate effectively with the Creative team and assist in developing resources that further collaboration
• Ensure that all written and designed content is accurate, meets editorial guidelines, adheres to client and brand requirements, and complies with FDA regulations
• Support copywriters in gathering and ensuring the accuracy of references and citations in preparation for submission, and in maintaining claim reference and citation libraries
• Conduct quality assurance on submissions to ensure that they are error-free and meet all internal, client, and FDA standards
• Track submissions through client MLR review and approval via internal tracking systems and client submission systems
• Actively participate in client MLR review meetings to seek clarification and obtain clear direction
• Enforce internal processes for editing, submission preparation, resubmission, and approval
• Shepherd change with all related team members to successfully implement process improvements; be firm yet flexible as the team adapts to change
• Support the onboarding and training of new and existing team members

Benefits

• Medical, Dental & Vision Insurance. We cover a generous portion of employee contributions
• 401K plan. We invest in present and future you, which is why we offer a generous match and immediate vesting on our plan
• Parental Leave. Generous paid time off for parents to bond with their newest addition
• Professional Development. Each employee has an annual budget to allocate to professional development opportunities. Employees are encouraged to take a workshop, attend a webinar, join associations, and do anything else that will help them grow in their careers.
• We offer flexible time off, life insurance, LTD, a robust employee assistance program, and more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 51-100 employees