The department vets copy that can pass the rigorous scrutiny of our clients’ medical-legal committees, as well as Health Canada and the FDA. The team also works with other capabilities to ensure that medical information is correctly conveyed within the creative execution. Once marketing materials are clean and scientifically sound, the department submits into submission platforms for approval by MLR, PAAB and the FDA.
Collaborate with Copy, Creative and Account Services to formulate medically sound marketing content- Review medically relevant, topical, and organized content for all types of marketing materials
- Evaluate the utility of sources supplied by the client and other agencies
- Educate Publicis Health Staff and freelancers on product research and claims limits
- Educate Publicis Health Staff and freelancers on disease states
- Educate Publicis Health Staff and freelancers on clients’ regulatory standards
- Review completed, referenced documents to ensure passage in the client’s regulatory approval process
- Be prepared to defend editorial content before the client’s regulatory review committees
- Support the work of the copywriters by finding appropriate literature
- Vet, query, and address medical and regulatory feedback from the client’s regulatory review team
- Submit marketing materials into MLR submission platforms with the appropriate annotations
2+ years of experience in medical writing or editing- Bachelor’s or Master’s degree in life sciences, and/or a degree in US/Canada regulatory affairs
- Familiarity with US and Canada pharmaceutical marketing formats
- Familiarity with US and Canada pharmaceutical marketing regulations
- Familiarity with medical-legal review processes
- Ability to supervise more junior members of staff
- Ability to read and interpret medical literature
- Ability to search for appropriate medical literature
- Must be capable of working both independently and in a team environment
- Must know how to use Microsoft Word software. Familiarity with Adobe Acrobat and Microsoft PowerPoint desirable
- Must have knowledge/experience in pharmaceutical regulatory submissions
