Medical Content Compliance Manager (remote or hybrid)

About the position At BI WORLDWIDE, we are committed to creating belongingness, where D&I is a priority. We invite you to join us as we continue to expand our culture of inclusivity, collaboration, and authenticity together. Our Learning & Org Effectiveness team is seeking a Medical Content & 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. 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.

Responsibilities

• Manage and oversee all aspects of our Medical Content.
• Ensure all medical content projects are scientifically sound and adhere to regulatory guidelines, industry standards, and client specific compliance requirements.
• Act as primary scientific client contact, provide direct oversight.
• Build, maintain, and manage a strong team of contractors with clinical/medical writing, editing and submission expertise.
• Responsible for process improvements that enhance the effectiveness of BIW's clinical/medical submissions.
• 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.
• Identify opportunities to expand existing client relationships and generate new business leads by conducting research of upcoming drug launches in the Pharma Industry.

Requirements

• Extensive knowledge of ethical guidelines and compliance requirements in the healthcare industry, including OPDP guidance
• Ability to fact check scientific statements and claims
• Ability to research and identify upcoming opportunities in Life Sciences pipelines
• Project management experience
• Excellent written and verbal communication
• Strong Leadership skills
• Resolution management experience
• Strong organization and attention to detail
• At least ~ 4 or more years of client services, account management experience within a medical communications agency setting.
• BA/BS College degree preferred -- Communications, Learning, Advertising, Marketing, event planning, or related field.
• Expert in referencing and annotating documents within content management platforms.
• Established and demonstrated presentation, organization, ownership, time management, communication, attention to detail, and customer focus skills.
• Proficiency in Microsoft Office suite, including Outlook, Word, Excel, and PowerPoint.

Nice-to-haves

• Experience with FUSE preferred, but not required

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