Medical Content Compliance Manager (remote or hybrid)

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.

• 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.

• 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
• Experience with FUSE preferred, but not required

• 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.

More details about our company benefits can be found at the following link: https://www.biworldwide.com/careers/benefits-page/