Managing Medical Editor
Job Description
The Medical & Regulatory department vets copy and design that can pass the rigorous scrutiny of our clients’ medical, legal and regulatory committees, as well as Health Canada and the FDA.
The team also works with other capabilities to ensure that medical and regulatory information is correctly conveyed within the creative execution.
The team is responsible for all submissions into Veeva for both the FDA and PAAB regulatory bodies.
DUTIES & RESPONSIBILITIES :
- Collaborate with Creative, Copy and Account Services to formulate medically sound marketing content
- Develop research reports for client presentations, strategy presentations, and new business proposals
- Review medically relevant, topical, and organized content for all types of marketing materials
- Educate 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 Medical Editors track by obtaining appropriate supportive literature and providing feedback from the client’s regulatory review
- Vet, query, and address medical and regulatory feedback from the client’s regulatory review team
- Oversee a team of Medical Editors, Submissions specialists and Freelancers
- Accepts, delegates and prioritizes work
Qualifications
- Master’s or doctoral level (MD, DO, PhD) degree in healthcare or communication.
- 5+ years of experience in medical writing or editing
- Expertise in pharmaceutical marketing formats
- Expertise in PAAB pharmaceutical marketing regulations
- Expertise in the medical, legal, and regulatory review processes
- Ability to supervise more junior members of staff
- Ability to read and interpret the medical literature
- Must be capable of working both independently and in a team environment
- Must know how to use Veeva, Adobe Acrobat and Microsoft PowerPoint desirable
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