Regulatory & Medical Affairs Submission Specialist

Healio Strategic Solutions is seeking an experienced Regulatory & Medical Affairs Submissions Specialist for our growing Custom Engagements team.

The Submissions Specialist will partner with Project Managers to ensure thorough submissions that follow protocols established by pharmaceutical clients when submitting marketing materials for review. This includes preparing completed editorial content to the Medical-Legal-Regulatory (MLR) review board and tracking the progress of each project through the various stages of MLR review.

This role will serve as the go-to expert on the client regulatory submission process and the systems/tools used for the submission. The role will also be responsible for staying abreast of updates, creating/maintaining the regulatory process documentation, and working closely with Project Managers to communicate updates.

This role is a combination of administrative and project coordination tasks. You will work across several clients and brands and be responsible for supporting the project teams on ancillary activities as needed.

Duties include:  

• Determine the time and effort required to complete each submission
• Establish a timeline and assign responsibility to the appropriate team members for the delivery of the components of the submission
• Create and/or oversee the creation of the components and ensure they conform to proper guidelines
• Maintain a comprehensive, accurate dashboard of all current and upcoming submissions including the stage of review, job codes, and deadlines
• Act as the primary point of contact with the clients' MLR Review department, both to get information regarding submissions requirements and to answer procedural questions that arise during the MLR review process
• Attend review committee meetings as needed to address questions and gather reviewers’ feedback
• Create and maintain change logs to track MLR-based revisions
• Attend initial/ongoing training updates on submission platform requirements
• Create, update, and disseminate to the rest of the department procedure(s) specific to the clients supported. Serve as the expert on system requirements.
• Manage multiple submissions and deadlines

Qualifications include:

• Minimum of a bachelor's degree and 2-4 years of experience in the preparation of complex deliverables under tight deadline constraints is required
• 2+ years of work experience in pharma advertising with knowledge of regulatory review process
• Technical competency in Chrome, Firefox, Adobe Acrobat, and the Microsoft Office Suite are required
• Experience communicating with external clients directly is required
• Clear communication and attention to detail are essential
• Expert in project management software, such as SmartSheet or similar applications
• Project management experience desired
• Strong planning and organization skills

Remote applicants are encouraged to apply.

The Wyanoke Group is the holding company for Healio, Healio Live, Healio Strategic Solutions, SLACK Incorporated, and Vindico Medical Education.  From medical journals, newspapers, and textbooks to websites and live events, it is our mission to deliver the highest quality information, education, and communications to customers around the world.

The Wyanoke Group is an equal opportunity employer and is committed to a diverse and inclusive workplace.  We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, current or prospective service in the uniformed services or disability.

The Wyanoke Group strives to instill a positive culture, an environment that encourages collaboration and learning from one another.  The Wyanoke Group recognizes the great people that allow us to accomplish great things.

And those same people who contribute to the success of our business every day are equally as committed to serving others in our community.  The Wyanoke Group enjoys doing its part through charitable fundraisers, sponsorships and events.