Offer summary

Qualifications:

Bachelor’s degree in English, healthcare, communications, or a similar field (Master’s preferred)., 2+ years of experience in editing or writing for a technical audience, particularly in medical or scientific contexts., Familiarity with FDA regulations and the AMA Manual of Style, 11th ed., Proficient in Adobe Acrobat, Microsoft Office Suite, and Mac OS..

Key responsabilities:

Oversee and ensure compliance of promotional content with FDA regulations and client-specific requirements.

Educate team members on regulatory processes and maintain documentation on compliance and submission preparation.

Collaborate with the Creative team to ensure accuracy and adherence to editorial guidelines in all content.

Conduct quality assurance on submissions and track them through client MLR review and approval processes.

Job description

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.

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

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
(Preferred) Background in health sciences
(Preferred) Familiarity with regulatory or legal review processes in healthcare or other regulated industry

Benefits

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.
Sabbatical Program. Enjoy 4 weeks of paid leave following 6 years of service to pursue travel, time with family, and drive in a new hobby; the options are endless!
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 $58,000 - $70,000 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.

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