Qureos Mentor

BI Worldwide

<div><p>At BI WORLDWIDE, we are committed to creating belongingness, where D&amp;I is a priority. We invite you to join us as we continue to expand our culture of inclusivity, collaboration, and authenticity together.</p>
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Our Learning &amp; Org Effectiveness team is seeking a Medical Content &amp; Compliance Manager. The Medical Content Compliance Manager will support Life Science Learning programs by managing all aspects of our medical content development and the accuracy of medical legal review submissions.
</p><div>If you reside outside of Minnesota, there is an option to work remotely in some states. We have a hybrid model (3 days at the office and 2 days remotely) for Minnesota employees.</div>
<div></div><div>Ability to travel and support onsite at live client meetings - 10%</div>
<div></div><div><b>Roles &amp; Responsibilities:</b></div>
<div></div><div>Medical Legal Compliance:</div>
<ul><li><div>Manage and oversee all aspects of our Medical Content.</div>
</li><li><div>Ensure all medical content projects are scientifically sound and adhere to regulatory guidelines, industry standards, and client specific compliance requirements.</div>
</li><li><div>Act as primary scientific client contact, provide direct oversight.</div>
</li><li><div>Build, maintain, and manage a strong team of contractors with clinical/medical writing, editing and submission expertise.</div>
</li><li><div>Responsible for process improvements that enhance the effectiveness of BIW's clinical/medical submissions.</div>
</li><li><div>Is fully fluent in submission requirements to ensure immediate submission backup and support when needed. Working with Learning and Field Business Development Directors to ensure proposals involving clinical/medical components are sound and accurate.</div>
</li></ul><div>Project Management / Account Support:</div>
<ul><li><div>Identify opportunities to expand existing client relationships and generate new business leads by conducting research of upcoming drug launches in the Pharma Industry.</div>
</li></ul><div></div><div><b>Knowledge, Skills &amp; Abilities:</b></div>
<ul><li><div>Extensive knowledge of ethical guidelines and compliance requirements in the healthcare industry, including OPDP guidance</div>
</li><li><div>Ability to fact check scientific statements and claims</div>
</li><li><div>Ability to research and identify upcoming opportunities in Life Sciences pipelines</div>
</li><li><div>Project management experience</div>
</li><li><div>Excellent written and verbal communication</div>
</li><li><div>Strong Leadership skills</div>
</li><li><div>Resolution management experience</div>
</li><li><div>Strong organization and attention to detail</div>
</li><li><div>Experience with FUSE preferred, but not required</div>
</li></ul><div></div><div><b>Education &amp; Experience Required:</b></div>
<ul><li><div>At least ~ 4 or more years of client services, account management experience within a medical communications agency setting.</div>
</li><li><div>BA/BS College degree preferred - Communications, Learning, Advertising, Marketing, event planning, or related field.</div>
</li><li><div>Expert in referencing and annotating documents within content management platforms.</div>
</li><li><div>Established and demonstrated presentation, organization, ownership, time management, communication, attention to detail, and customer focus skills.</div>
</li><li><div>Proficiency in Microsoft Office suite, including Outlook, Word, Excel, and PowerPoint.</div>
</li></ul><div></div><div>Base Salary Range: $105,000 to $120,000. Final salary and offer will be determined by the applicant's background, experience, and skills.</div>
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More details about our company benefits can be found at the following link: https://www.biworldwide.com/careers/benefits-page/</p></div><p></p>

Medical Content Compliance Manager (remote or hybrid)

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Medical Content Compliance Manager (remote or hybrid)