CG Life

Compensation

Full Description

CG Life is seeking a Senior Regulatory Specialist to serve as key agency regulatory expert. The Senior Regulatory Specialist is accountable and responsible for overseeing, educating, and advising on the medical, legal, and regulatory (MLR) aspects of promotional material development. The Senior Regulatory Specialist will ensure the accuracy and integrity of all promotional content for our healthcare (pharma) clients. This includes ensuring compliance with all applicable FDA regulations and guidance, client-specific requirements, and editorial guidelines. For all assigned projects, the they oversees all regulatory-related efforts, prepares submissions, ensures incorporation of MLR feedback, and guides submissions to MLR approval, and is expected to adhere to, optimize, and evangelize internal workflow processes. The Senior Regulatory Specialist grows the regulatory knowledge of the agency to ensure compliance and maintain a high level of submission quality. They shows leadership in guiding teams through challenging submissions and product launches. Responsibilities Serve as the agency expert on internal and client regulatory processes and requirements as well as FDA regulations and guidance and educate team members about them. Identify trends, risks, patterns, and precedents in the MLR process to inform our content creation and speed up the approval process, and increase the expertise of the agency as a whole by seeking and sharing knowledge. Advise Project Management, Client Services, and Strategy team members on regulatory risk considerations and MLR submission strategy for current projects as well as tactical planning and proposals. Establish positive relationships with new client MLR teams, learn their processes, onboard internal teams, and work with the Project Management team to develop and optimize internal processes as needed. Develop, maintain, and optimize documentation on regulatory compliance, submission preparation processes, and client-specific MLR requirements. Identify needs and develop resources and training for effective collaboration with the Creative team. 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 ensure the maintenance of claim reference and citation libraries. Prepare submissions for MLR review, ensuring 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. Act as an agency regulatory expert in client MLR review meetings to seek clarification, obtain clear direction, answer questions, and maintain positive MLR relationships. Lead the regulatory efforts for complex, high-priority, and high-visibility projects such as product launches, including working closely with the Project Management team on submission process and strategy, educating team members, and maintaining communication, collaboration, optimism, and empathy through challenging situations. Define, optimize, and enforce internal processes to create improvements and efficiencies in editing, submission preparation, resubmission, and approval. Spearhead change to successfully implement process improvements; be firm yet flexible as the team adapts to change. Bachelor’s degree in English, healthcare, communications or similar, or similarly relevant degree 2+ years experience in regulatory work or 4+ years 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 Experience developing/optimizing processes and best practices in business environments 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 (Preferred) Familiarity with regulatory or legal review processes in healthcare or other regulated industry (Preferred) Working knowledge of Veeva Vault PromoMats or similar content management and review platform We are proud to offer a comprehensive benefits package to all of our employees: 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. And more! We offer flexible time off, life insurance, LTD, a robust employee assistance program, and more! At CG Life, we recognize that attracting the best talent is key to our strategy and success as a company. As a result, we aim for flexibility in structuring competitive compensation offers to ensure we are able to attract the best candidates. As required by law in this state, the estimated salary range for this position is $80,000 - $95,000 and represents our good faith estimate as to what our ideal candidates are likely to expect. We tailor our offers within the range based on organizational needs, internal equity, market data, geographic zone, and the selected candidate’s experience, education, industry knowledge, location, technical and communication skills, and other factors that may prove relevant during the selection process. At CG Life, it is not common for individuals to be hired at the higher end of the range, and compensation decisions depend on a variety of factors. This position is eligible to participate in a discretionary bonus program, subject to the rules governing the plan. CG Life offers a variety of benefits, including health benefits, 401K retirement with a generous company match and immediate vesting, and flexible time off. This job posting is intended for direct applicants only; please, no outside recruiters.