CG Life · 8 hours ago
Regulatory Specialist
United States
Full-time
Remote
Entry, Mid Level
$55K/yr - $70K/yr
2+ years expCG Life is a company focused on healthcare marketing and communications, and they are seeking a Regulatory Specialist to oversee and advise on the medical, legal, and regulatory aspects of promotional material development. The role involves ensuring compliance with FDA regulations and maintaining the accuracy of promotional content for healthcare clients.
Marketing & Advertising
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
Qualification
Required
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
Preferred
Background in health sciences
Familiarity with regulatory or legal review processes in healthcare or other regulated industry
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.
Flexible time off
Life insurance
LTD
A robust employee assistance program
Company
CG Life
CG Life is a different breed of agency, built for the unique challenges of bringing precision medicine to market.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Erik Clausen
Managing Partner
Murad Sabzali
Founding Partner, Board Director
Recent News
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